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Zavotsky, K.E., Banavage, A., James, P., Easter, K., Pontieri-Lewis, V., & Lutwin, L. (2014). The effects of music on pain and anxiety during screening mammography. Clinical Journal of Oncology Nursing, 18, E45–E49.

Study Purpose

To test whether women who listened to music during screening mammography report lower levels of pain and anxiety than women who did not listen to music

Intervention Characteristics/Basic Study Process

On three days of the week, patients listened to music during screening mammorgraphy, and on two days of the week, music was not provided. An MP3 player was preloaded with various types of music. Patients who were part of the music group were asked to select the music of their choice. Patients rated pain and anxiety immediately after completing the mammography.

Sample Characteristics

  • N = 100
  • MEAN AGE = 54.1 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Most were Caucasian. About 45% had had 13 or more previous mammographies.
     

Setting

  • SITE: Multi-site 
  • SETTING TYPE: Outpatient 
  • LOCATION: United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic

Study Design

  • Non-random, two-group comparison

Measurement Instruments/Methods

  • 10-point Likert-type scale for pain and anxiety

Results

No significant differences in pain or anxiety were seen between groups.

Conclusions

This study did not show an effect of listening to music during mammography on pain or anxiety.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • No baseline anxiety measures—if patients were not anxious to begin with, they unlikely would have a result.

Nursing Implications

This study did not show an effect of listening to music during screening mammography, but evidence has shown effectiveness of music in reducing anxiety during invasive procedures. Listening to music during mammography is a low-cost and low-risk intervention that may be helpful to some patients. This study had multiple limitations.

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Zanin, T., Zanin, F., Carvalhosa, A.A., Castro, P.H., Pacheco, M.T., Zanin, I.C., … Brugnera, Jr., A.  (2010). Use of 660-nm diode laser in the prevention and treatment of human oral mucositis induced by radiotherapy and chemotherapy. Photomedicine and Laser Surgery, 28, 233–237.

Study Purpose

To evaluate the qualitative and quantitative effects of the 660-nm diode laser in the prevention and treatment of oral mucositis in patients with head and neck cancer being treated with chemotherapy and radiation

Intervention Characteristics/Basic Study Process

Seventy-two patients were divided into two groups. One group was the control, and the other group received low-level laser therapy twice weekly. Teeth were protected using a silicone tray containing neutral fluoride gel. Daily physical intraoral evaluations were performed. Patients were followed for seven weeks during radiation treatment.

Sample Characteristics

  • The study reported on 72 patients with head and neck cancer receiving treatment that included 1.8 gy radiation and 70 mg/mcisplatin weekly.
  • The sample had an age range of 34–80 years.
  • The sample was 83% male and 17% female.

Setting

This was a single-site study conducted at the Cancer Hospital of Mato-Grasso, Cuiaba, MT, Brazil.

Study Design

The study was a prospective clinical trial.

Measurement Instruments/Methods

  • A visual analog scale (VAS) was used to measure severity of oral pain.
  • The Brown scale was used to evaluate incidence of oral mucositis.
  • The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) was used.
  • Patients received daily physical intraoral exams.

Results

  • Patients in the laser group had significantly lower NCI mucositis scores throughout the study period (p < 0.001).
  • Patients in the laser groups reported absence of pain during treatment, and controls reported increasing pain from weeks 1–4. Overall differences were significant (p = 0.05).

Conclusions

This study found that 660-nm diode laser therapy was effective in the prevention and treatment of oral mucositis in patients being treated with chemotherapy and radiation for head and neck carcinoma.

Limitations

  • The sample size was small with fewer than 100 patients.
  • The control group was not adequately described, including whether they received sham treatment.
  • A risk of bias exists because the patients were not randomly assigned to groups. Addtionally, the study was not blinded.
  • The report did not include a discussion of other oral care or medications used.

Nursing Implications

Low level laser therapy may be effective in the prevention of mucositis. However, this treatment is highly technical and requires special equipment and highly trained personnel.

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Zang, J., Hou, M., Gou, H.F., Qiu, M., Wang, J., Zhou, X.J., … Yi, C. (2011). Antiemetic activity of megestrol acetate in patients receiving chemotherapy. Supportive Care in Cancer, 19, 667–673.

Study Purpose

To evaluate the antiemetic properties of megestrol acetate (MA) in patients receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive either MA or placebo combined with routine antiemetic medications during the first cycle of chemotherapy and used the alternative during the second cycle. Patients were given oral MA or a placebo tablet prior to the start of chemotherapy then daily on days 1–4 of the chemotherapy. All patients were given granisetron and metoclopramide daily on days 1–4 of chemotherapy. Patients received either MEC or HEC for one day. Patients recorded nausea, vomiting, and adverse experiences daily on diary cards during days 1–5 of chemotherapy.

Sample Characteristics

  • The sample consisted of 100 patients.
  • Mean age was 51.6 years (SD = 10 years).
  • The sample was 39% female and 61% male.
  • Cancer diagnoses were 67% alimentary tract cancer (including esophageal cancer, gastric cancer, colorectal cancer) and 33% lung cancer.
  • Slightly more than half (56%) of patients received HEC, and 44% received MEC.
  • Patients were not eligible for the study if they experienced nausea or vomiting before the start of chemotherapy or if they used antiemetic agents within 72 hours of the study.

Setting

The study was conducted at a single cancer center in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized, single-blind, placebo-controlled, crossover study.

Measurement Instruments/Methods

Patients recorded each emetic episode, their assessment of nausea and global satisfaction, and occurrence of any adverse effects on diary cards.

Results

  • MA combined with granisetron and metoclopramide provided higher protection of chemotherapy-induced nausea and vomiting (CINV) (p = 0.000) than no MA.
  • HEC patients who received MA had less CINV in comparison to patients with no MA (p = 0.001).
  • MEC patients who received MA had less CINV than patients with no MA (p = 0.002).
  • In the acute phase, nausea was higher (p = 0.039) and vomiting was more frequent (p = 0.003) without MA than with MA.
  • In the delayed phase, nausea (p = 0.000) and vomiting (p = 0.000) were lower with MA than without.
  • All adverse events were mild and did not cause patients to discontinue the drug.

Conclusions

MA provides higher rates of CINV protection in the acute and delayed phase of chemotherapy, especially the delayed phase. MA is effective in patients receiving HEC and MEC.

Limitations

  • This was a single institution study.
  • Demographic characteristics were not reported between the two different groups of subjects (MA versus placebo); therefore, it is unclear if characteristic differences may have influenced outcomes.

Nursing Implications

MA may have some antiemetic activity in patients receiving moderate to highly emetic chemotherapy and should be considered as part of an antiemetic regimen.

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Zachariah, B., Gwede, C.K., James, J., Ajani, J., Chin, L.J., Donath, D., … Kachnic, L.A. (2010). Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: Randomized RTOG trial 0315. Journal of the National Cancer Institute, 102(8), 547-556.

Study Purpose

To assess the ability of long-acting octerotide (LAO) to prevent acute diarrhea in patients undergoing concurrent chemoradiation for rectal or anal cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to either receive two 30 mg intramuscular injections of LAO or placebo. A “test” dose of 100 µg LAO was administered. Patients who tolerated the test dose then received a 30-mg dose of study drug between days 4–7 before the start of radiation and a second dose on day 22 (+ 3 days) of radiation. Patients received concurrent chemotherapy and radiation therapy to the pelvis. Radiation and chemotherapy regimens varied by institution. The plan was for a minimal dose of 45 Gy with a portal of 10x10 cm to the whole pelvis and a boost to the tumor bed. Follow-up evaluations were performed 3, 6, 9, and 15 months from start of radiation therapy.

Sample Characteristics

  • The study reported on 215 patients.
  • The mean age of patients in the LAO group was 61 years with a range of 27–83 years. The mean age of patients in the placebo group was 61 years with a range of 37–85 years.
  • The LAO sample was 38% female and 62% male. The placebo group was 36% female and 64% male.
  • The majority (80%) of patients had rectal cancer.

Setting

The study was conducted at multiple outpatient settings in the United States.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, double-blinded, placebo-controlled trial.

Measurement Instruments/Methods

The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (version 3.0) (CTCAE), Qualify of Life–Radiation Therapy Instrument (QOL-RTI), 14-item Expanded Prostate Cancer Index (EPIC)–Bowel, 7-item Functional Alterations due to Changes in Elimination–Bowel (FACE-Bowel), and 4-item Diarrhea Assessment Scale (DAS) were used.

Results

  • Prophylactic use of LAO is not beneficial in reducing the severity or preventing the incidence of diarrhea in patients receiving concurrent chemotherapy and radiation therapy for rectal or anal cancer.
  • Incidence of grade 2–4 acute diarrhea was similar in both groups (49% in the placebo group versus 44% in the LAO group).
  • LAO did not reduce the number of hospitalizations required (p = 0.55) or eliminate the need for additional standard antidiarrheal agents (p = 0.67).
  • LAO did not prevent modifications, delays, or interruptions in chemotherapy (p = 0.27) or radiation therapy (p = 0.95).

Conclusions

LAO did not demonstrate a statistically significant reduction in the incidence or severity of diarrhea or change in patient-reported bowel function and QOL in patients with rectal or anal cancer undergoing chemotherapy and radiation therapy.

Limitations

  • No intention-to-treat analysis was performed.
  • This study had a short follow-up timeframe with a median follow-up of only 9.64 months. Further long-term assessment should be conducted to evaluate QOL.

Nursing Implications

More clinical research is needed to evaluate interventions for the prevention of diarrhea in patients receiving chemotherapy and radiation therapy concurrently for rectal or anal cancer. LAO does not appear to reduce the incidence or severity of diarrhea or change patient-reported bowel function or QOL. Other studies have reported similar results. LAO should not be used to prevent diarrhea in patients receiving combined chemotherapy and radiation therapy outside of a controlled clinical research setting.

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Yu, Z., Liu, W., Wang, L., Liang, H., Huang, Y., Si, X., … Zhang, H. (2009). The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: A phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial. Supportive Care in Cancer, 17, 99–102. 

Study Purpose

To evaluate the safety and efficacy of palonosetron versus granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive a single IV dose of either palonosetron 0.25 mg or granisetron 3 mg as a bolus dose, 30 minutes before receiving chemotherapy. Patients were evaluated daily from study days 1–7, and investigators were responsible for recording emetic episodes, rescue medication, and adverse events. Complete response was defined as no emetic episodes and no rescue medication for the first 24-hour interval after chemotherapy and during successive 24-hour time periods.

Sample Characteristics

  • The study consisted of 208 participants.
  • Mean age was 51.5 years.
  • The study group was 36.54% female and 63.46% male.
  • The most common cancer types were non-small cell lung, gastric, and breast cancers. A variety of other types were included.
  • The majority of the palonosetron group (92%) and the granisetron group (87%) were receiving cisplatin-containing chemotherapy; 17% in the granisetron and 19% in the palonosetron group were receiving epirubicin-containing therapy.
  • Approximately half of the sample was chemotherapy naïve.

Setting

The study was conducted at multiple sites in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a double-blind, randomized, parallel comparative study.

Measurement Instruments/Methods

Evaluation was based on the World Health Organization's evaluation criteria of emesis. Emetic episodes and use of rescue medication were recorded.

 

Results

  • No significant differences were reported between groups in complete response rates.
  • In the granisetron group, 72% of patients had complete response in the 0–24 hour period compared to 83% in the palonosetron group.
  • Response rates declined in both groups from 24–96 hours.
  • No clinically relevant differences were reported between groups in overall incidence of adverse events.
  • No serious adverse events were found to be associated with the study drugs.
  • The most frequent adverse events were headache and constipation.

Conclusions

Palonosetron and granisetron appeared to provide similar results in control of CINV in the immediate, acute phase.

Limitations

  • The level and distribution of emetogenicity of chemotherapeutic regimens was not described, and no subgroup analysis based on this was done.
  • Nausea was not measured.
  • Methods of blinding were not described.
  • Reliability of recording vomiting and nausea episodes was unclear.
  • The authors did not report if the study was conducted in an inpatient setting.
  • The study only looked at single dose adminiatration, and the study had a short duration.

Nursing Implications

  • Palonosetron and granisetron appear to have similar efficacy and tolerability for the management of CINV in the immediate acute period.
  • Most patients (70%–80%) in the study population had an effective short-term response.
  • Response was less in the delayed phase.
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Yun, Y. H., Lee, K. S., Kim, Y. W., Park, S. Y., Lee, E. S., Noh, D. Y., . . . Park, S. (2012). Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial. Journal of Clinical Oncology, 30, 1296–1303.

Study Purpose

To determine if an internet-based, tailored, psychoeducational program was effective in the management of fatigue and other symptoms for patients with cancer-related fatigue.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to a tailored, web-based, health navigation program or usual care. The 12-week intervention program covered energy conservation, physical activity, nutrition, sleep hygiene, pain control, and distress management. The program included online education, health advice, message services, caregiver monitoring, and support and educational sessions. Principles of cognitive-behavioral therapy were used in the program design. The program was provided via a health navigation web site. Study measures were obtained at baseline and at the end of 12 weeks. Intention-to-treat (ITT) analysis was performed using the last observation carried forward for missing values.

Sample Characteristics

  • In total, 243 patients (23% male, 77% female) were included.    
  • Mean age was not provided; 53.5% of the patients were 45 years or older. 
  • Multiple tumor sites were included, with 38.6% being breast cancer.
  • Slightly greater than 94% of the patients had completed high school or higher education. 
  • Global Brief Fatigue Inventory (BFI) scores at baseline were an average of 4.13 across the study groups. 
  • At baseline, mean anxiety score was 6.46 and mean depression score was 5.7. 
  • All patients had fatigue scores at baseline of 4 or greater for at least one week and had completed primary treatment within the past 24 months.

Setting

  • Single site 
  • Home 
  • South Korea

Study Design

The study was a randomized, controlled trial with a wait-list control.

Measurement Instruments/Methods

  • BFI
  • Health-related quality of life (HRQOL)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30)
  • Hospital Anxiety and Depression Scale (HADS)
  • Brief Pain Inventory (BPI)
  • Mini Nutritional Assessment (MNA)
  • Medical Outcomes Study (MOS) Sleep Scale

Results

The intervention group had a significantly larger reduction in fatigue scores (p = 0.0011), with an effect size of 0.29 (Cohen’s d). The intervention group also had a greater improvement in anxiety score and several quality of life–related scale scores (p < 0.05). Multiple variables were statistically significant predictors of change in fatigue scores.

Conclusions

Health navigation, the psychoeducational intervention used here, had a slight to moderate positive effect in reducing fatigue.

Limitations

  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • Key sample group differences could have influenced the results.
  • Patient withdrawals were 10% or greater. The patient withdrawal rate was 29% overall and 31% in the intervention group.
  • At baseline, BFI scores were lower in the intervention group, so the method of ITT analysis may have overestimated the lower fatigue scores at follow-up for this group.
  • The withdrawal and loss to follow-up rate in the intervention group suggested that the intervention may not be well received by several patients.

Nursing Implications

The findings suggested that a psychoeducational program delivered via a web-based program may be helpful for some patients for the management of fatigue. Although the study was limited by a high withdrawal rate in the intervention group, the majority of patients continued with the program. This may be a practical approach that is helpful to some patients. Further research in the area of facilitating and encouraging patient participation in such programs would be useful.

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Yun, Y.H., Lee, M.K., Park, S., Lee, J.L., Park, J., Choi, Y.S., . . . Hong, Y.S. (2011). Use of a decision aid to help caregivers discuss terminal disease status with a family member with cancer: A randomized controlled trial. Journal of Clinical Oncology, 29, 4811–4819.

Study Purpose

To test whether a decision aid (DA) consisting of a videotape and workbook focused on explaining how to discuss death with family members is more effective than a videotape and workbook on patient pain control for caregivers of patients with cancer

Intervention Characteristics/Basic Study Process

A computerized random number generator blindly assigned caregivers to either a study treatment arm or a control arm with stratification according to caregiver age and patients’ awareness of their terminal status. The treatment group received a DA consisting of a 20-minute take-home educational DVD and a companion 43-page workbook, Patients Want to Know the Truth, for family members’ disclosure of terminal status to patients intended to facilitate decision making of patient–caregiver dyads. The authors developed and rigorously tested the DA, based on the transtheoretical model, in several earlier studies that appear in refereed journals to support its current study use. The control group received a National Cancer Institute–developed, Korean language DVD of similar length and a 29-page educational booklet developed by the Korean Ministry of Health and Welfare on cancer pain control. Both treatment and control groups were observed and assessed at the same intervals: zero, one, three, and six months.

Sample Characteristics

  • The sample (N = 119) included 63 participants in the intervention group and 56 participants in the control group. 
  • Patient mean age was 61.9 years (SD = 12.9); caregiver mean age was 45.6 years (SD = 11.8).
  • The patient sample was 57.2% male and 42.8% female; the caregiver sample was 33.2% male and 66.8% female.
  • Patients were diagnosed with breast cancer (18.5%), lung cancer (15.1%), terminal stomach cancer (14.6%), colon cancer (12%), liver cancer (7.4%), and “other\" cancers (42.5%).
  • All patients were defined as terminally ill and nonresponsive to conventional cancer therapy.
  • All caregivers were a spouse, parent, or child of the patient, 80% were married, 40% had college education or higher, 69% believed in a religion, and most were urban dwellers who had a monthly household income of $2,000 or more.

Setting

  • Multisite
  • Inpatient and outpatient settings
  • Korea

Phase of Care and Clinical Applications

  • End-of-life phase
  • End-of-life and palliative care; education; quality of life

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Decision Conflict Scale (DCS): Used to assess caregiver perceptions of decisional conflict (uncertainty in making choices, feeling informed, clarity of personal values, and receipt of decision-making support) and satisfaction with choice; five-point Likert scale with 0.90 Cronbach’s alpha; administered to caregivers at zero, one, three, and six months   
  • Hospital Anxiety and Depression Scale (HADS): Used to measure caregiver psychological distress; Cronbach’s alphas for two factors ranged from 0.81 to 0.85; administered to caregivers at zero, one, three, and six months     
  • Caregiver Quality of Life Index–Cancer (CQOL): Used to measure caregiver quality of life with cancer; five-point Likert scale and Cronbach’s alpha of 0.89; administered to caregivers at zero, one, three, and six months
  • Decision Regret Scale (DRS): Used to measure caregiver regret with decision to discuss terminal diagnosis with patient; five-point Likert scale and Cronbach’s alpha of 0.89; administered to caregivers at one, three, and six months

Results

Sociodemographic and clinical characteristics of the treatment and control groups did not differ significantly, nor were there significant between-group differences in baseline DCS, HADS, or CQOL-C scores. By six-month assessment, only 26.8% of the total sample remained. Decisional conflict and satisfaction total score and conflict, uncertainty, and value clarity subscale scores significantly improved from baseline to one month for the treatment group as compared to the control group. Over six months, significant between-group differences continued for the DCS total score (p = 0.40) and subscales for conflict (p = 0.031), uncertainty (p = 0.014), and value clarity (p = 0.039). Depression scores improved significantly more in the treatment group than in the control group, and this was sustained over six months (p = 0.008). In the caregiver groups in which patients knew their terminal diagnosis, at six months, DCS uncertainty and depression scores (p = 0.029 and p = 0.031, respectively) showed significant improvement in the treatment (DA) group as opposed to the control group. In the caregiver groups in which patients did not know their terminal status, only the value clarity and depression subscale scores (p = 0.037 and p = 0.032, respectively) showed significance, with greater improvement in the treatment group at six months.

Conclusions

Theoretically based DAs appear to help caregivers of patients with cancer communicate with terminally patients if trained professionals assist those caregivers in the process of using them. This study found that the use of a DA did not improve the decision to discuss terminal prognosis but did reduce caregivers’ decisional conflict and depression, which is congruent with other literature. The caregivers in the treatment group did not have a decrease in anxiety.

Limitations

  • The sample included Koreans only. The DA needs to be tested with other diverse groups and illness populations. 
  • There was high attrition of the sample over the duration of the study (more than 70% in both the control and intervention groups); hence, this was a low-powered study despite the authors’ early determination of needed sample for statistically significant results.

Nursing Implications

Nurses have a primary role in assisting patients and caregivers in making treatment decisions to improve the quality of decision making for both groups. Helping patients become involved in decision making is an important facet of patient-centered care. Face-to-face discussions among nurses, patients, and caregivers often facilitate family coping when nurses engage in astute assessment and establish a trusting relationship with patients and their caregivers to understand their concerns. Use of DAs may provide an additional way to educate and empower patients and caregivers for difficult conversations, including those surrounding end-of-life prognosis and decisions. Nursing support and conversations about the efficacy of DAs for both patients and caregivers can offer greater insight into needed components of care to meet goals for quality patient and caregiver care during the cancer trajectory.

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Yuen, K.K., Shelley, M., Sze, W.M., Wilt, T., & Mason, M.D. (2010). Bisphosphonates for advanced prostate cancer. Cochrane Database of Systematic Reviews 2010(2).

Purpose

To determine the effectiveness of bisphosphonates in relieving the bone pain of patients with bone metastases from prostate cancer

Search Strategy

  • Databases searched were MEDLINE, EMBASE, LILACS, the Database of Abstracts of Reviews of Effects (DARE), Allied and Complementary Medicine Database (AMED), and the Cochrane Central Register of Controlled Trials (CENTRAL). Investigators performed manual searches of reference lists and proceedings of the American Society of Clinical Oncology.
  • Search keywords included bone neoplasms, osseous metastasis, cancer or carcinoma and bisphosphonates or diphosphonates. Authors included an extensive list of search terms in their review.
  • Studies were included if they
    • Were randomized controlled trials that assessed the effect of bisphosphonates in prostate cancer patients with bone metastases
    • Measured pain as one of the outcome variables
  • Studies were excluded if the primary site of the cancer was not the prostate, if the treatment assessed was a radioactive bisphosphonate, or if the study was an abstract or unpublished.

Literature Evaluated

  • The search identified 23 studies. After exclusions, the set of studies to be investigated included 10 studies.
  • The sample size of the 10 studies was 1,955 patients. 
  • Range of sample size across studies was 55–378 patients.
  • Investigators evaluated study quality by using the Jadad scale.

Sample Characteristics

The final sample of 10 studies included placebo-controlled and active controlled studies of patients with prostate cancer and confirmed bone metastases.

Results

  • Four studies analyzed pain response. There was no significant heterogeneity. The overall odds ratio (OR) was in favor of bisphosphonates over placebo (OR = 1.64, 95% CI 1.02–2.61, p = 0.07).
  • Four studies assessed mean pain change. Because the four studies were extremely heterogeneous, investigators could perform no meaningful analysis.
  • In regard to analgestic consumption, investigators noted no significant heterogeneity. The overall OR showed no difference between bisphosphonates and placebo in terms of reduced analgesic consumption.
  • In regard to skeletal events, investigators noted a marginally significant difference: Incidence of skeletal effects was lower for patients using bisphosphonates than for patients using placebo (OR = 0.79, 95% CI 0.62–1.0, p = 0.05).
  • In terms of adverse events, the analysis showed a significant increase in nausea with bisphosphonates.
  • Authors also analyzed findings related to quality of life, survival, disease progression, and prostate-specific antigen.
  • No study compared different types of bisphosphonates.

Conclusions

Compared to patients receiving placebo, a higher proportion of patients receiving bisphosphonates reported a decrease in skeletal events. Use of bisphosphonates was associated with increased nausea. Findings supported the use bisphosphonates for reduction of the bone pain associated with prostate cancer. However, findings did not show that bisphosphonates made any difference in analgesic use or consumption.

Limitations

This review was limited to prostate cancer patients with bone metastases. Authors noted that findings were influenced by the way in which studies were analyzed. In general, analysis of the number of evaluable patients favored bisphosphonates, but intention-to-treat analysis revealed no difference between treatments. Invesigators also saw that results differed according to how data from active study arms were handled. In one key study, when data from study arms were analyzed individually, meta-analysis was significant; however when data from active arms were combined, investigators noted no statistical difference relating to bisphosphonate use.

Nursing Implications

Bisphosphonate appears to have a role in decreasing pain and skeletal complications in patients with metastatic prostate cancer. Nausea appears to be the most frequent side effect associated with bisphosphate use. Data are insufficient to allow researchers to determine the most appropriate bisphosphonate choice, dose, or route of administration. More research is needed to determine the most effective treatment schedules and cost-effectiveness.

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Yue, T., Zhuang, D., Zhou, P., Zheng, L., Fan, Z., Zhu, J., ... & He, Q. (2015). A prospective study to assess the feasibility of axillary reverse mapping and evaluate its effect on preventing lymphedema in breast cancer patients. Clinical Breast Cancer, 15, 301–306. 

Study Purpose

To determine if lymphedema prevention is affected by the use of the axillary reverse mapping (ARM) procedure

Intervention Characteristics/Basic Study Process

Two groups of patients with breast cancer receiving modified radical mastectomies were randomized to a standard axillary lymph node dissection (ALND) or ALND with ARM.

Sample Characteristics

  • N = 265
  • AVERAGE AGE = 50.14 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis; invasive and in situ ductal carcinomas; metastatic lymph nodes from 1–10+ included; any hormone receptor or HER2 status; all tumor sizes for staging
  • OTHER KEY SAMPLE CHARACTERISTICS: Exclusion of neoadjuvant treatment patients and those with bilateral breast cancer; removal from study if experimental (ARM) group had positive ARM nodes on a pathology study

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Jinan Military Hospital in Jinan, China

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Preoperative Tc-Nanocoll injections with lymphoscintigraphy
  • Methylene blue injections
  • Intraoperative gamma probe
  • Student T test
  • Fisher exact test
  • Arm circumference measurement

Results

Between the experimental and the control group, there was a significant difference (p < 0.001) for both areas of circumference measurement in postoperative lymphedema evaluations. The experimental ARM group had less occurrence of lymphedema.

Conclusions

Based on the data presented by the investigators the incidence of lymphedema and the severity of lymphedema can be reduced by evaluating which lymph nodes really need to be removed to allow for the best lymphatic flow.

Limitations

  • Risk of bias (no blinding)
  • Other limitations/explanation: Patient weight and height or body surface area not collected (can affect lymphedema risk); no mention of prior history of breast cancer or radiation to upper body; risk factors not included such as diabetes, vascular disease, or other cancers; risk of bias; no blinding; there was no blinding for the ARM versus standard procedure; but for follow-up measurement of arm circumference for lymphedema assessment; the person measuring was blinded

Nursing Implications

Although this intervention doesn't change what staff nurses may do for patients on a day to day basis, it does allow nurses to educate patients about options as well as to open discussion with the oncology team as to the use of this newer intervention.

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Yuan, D.M., Li, Q., Zhang, Q., Xiao, X.W., Yao, Y.W., Zhang, Y., . . . Song, Y. (2016). Efficacy and safety of neurokinin-1 receptor antagonists for prevention of chemotherapy-induced nausea and vomiting: Systematic review and meta-analysis of randomized controlled trials. Asian Pacific Journal of Cancer Prevention, 17, 1661–1675. 

Purpose

STUDY PURPOSE: To evaluate the efficacy and safety of neurokinin-1 receptor antagonists (NK1s) for the prevention of chemotherapy-induced nausea and vomiting (CINV) among children and adolescents

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, Cochrane Library, ISI Web of Science, and a manual search of references
 
INCLUSION CRITERIA: Randomized controlled trials (RCTs) that compared NK1 (alone or combined with other antiemetics) to non-NK1s antiemetics, adequate data on the outcome or toxicity of each treatment, and prospective RCTs
 
EXCLUSION CRITERIA: Case reports, reviews, conference reports, or studies with overlapping cohorts from the same institutions

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 4,722
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Heterogeneity was evaluated with Higgins I2. Publication bias was evaluated with the Begg funnel plot and the Egger test.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 38 articles (32 for overall complete response [CR] analysis, 34 for acute CR analysis, 33 for delayed CR analysis, and 35 for toxicity analysis)
  • TOTAL PATIENTS INCLUDED IN REVIEW = 13,923 patients (12,820 for overall, 13,561 for acute, and 13,385 for delayed; number not reported for toxicity analysis)
  • SAMPLE RANGE ACROSS STUDIES: 35–1,917 patients
  • KEY SAMPLE CHARACTERISTICS: The studies occurred in multiple countries with multiple types of malignancies. NK1s were used with 5-HT3s and dexamethasone in 30 studies. Aprepitant was used in 29 studies (NK1s most common).

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Pediatrics, elder care

Results

Overall: Those with NK1 had 71% CR, and those with out NK1 (control group) had 56% CR (p < 0.001). Subgroup analysis showed that aprepitant had significantly higher CR than the control (64% versus 51%, p < 0.001), but fosaprepitant had no difference (p = 0.311). 

Acute Phase: Those with NK1 had 85% CR, and those without NK1 had 79.6% CR (p < 0.001). Subgroup analysis showed that those with oral or IV NK1 had significantly better CR (p < 0.001 for both groups) than those without NK1, but no significant difference occurred if NK1 was used intravenously on day 1 followed with oral NK1 (p = 0.685). NK1 used in combination with 5-HT3 alone or 5-HT3 plus dexamethasone had higher CR (p = 0.001 and < 0.001, respectively), but no difference occurred if NK1 was used with dexamethasone alone (p = 0.274).  

Delayed Phase: Those with NK1 had 71% CR, and those without NK1 had 58% CR (p < 0.001). Children or Adolescents: NK1 had increased CR in the overall phase (p < 0.001), acute phase (p = 0.012), and delayed phase (p < 0.001).

Other Outcomes: Compared to the control group, NK1 showed less incidence of nausea (45.2% versus 45.9%, p < 0.001), less vomiting (22.6% versus 38.9%, p < 0.001), and less use of rescue drugs (23.5% versus 34.1%, p < 0.001).

Adverse Events: NK1 did not increase the incidence of adverse events (69% versus 65%, p = 0.204), and no difference was noted among the three pediatric studies (80% versus 77%, p = 0.497).

Conclusions

The review confirms that the addition of NK1 to 5-HT3 alone or 5-HT3 plus dexamethasone is effective in achieving complete remission of chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases with no significant increase in adverse events. The addition of NK1 is also effective for children and adolescents in the acute and delayed phases with no significant increase in adverse events.

Limitations

  • No quality evaluation
  • Low sample sizes
  • Only three studies evaluated efficacy and safety in children and adolescents

Nursing Implications

A NK1, specifically aprepitant, is effective in preventing CINV during the acute or delayed phases of treatment, but the medication should be administered consistently either orally or intravenously. Changing the IV route to oral is not effective.

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