To investigate the safety and efficacy of intrathecal dexmedetomidine with or without fentanyl

Patients were randomly assigned to one of three groups. The control group received 0.5% bupivacaine and saline intrathecally, the second group received bupivacaine and 5 mcg of dexmedetomidine, and the third group received bupivacaine, 5 mcg of dexmedetomidine, and 25 mcg of fentanyl intrathecally prior to anesthesia. All patients received 5 mg of oral diazepam the night before surgery. Pain was assessed immediately after surgery and at two, four, six, eight, 12, and 24 hours. Postoperatively, intravenous tramadol at 100 mg was given upon patient request or if pain scores were three or greater.

• N = 90  
• MEAN AGE = 44.31 years
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: All patients were receiving major abdominal surgeries. Specific disease types were not reported.

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Egypt

• PHASE OF CARE: Active antitumor treatment

Double-blinded, randomized, three-arm trial

• Visual Analog Scale (VAS) for pain severity
• Observers Assessment of Alertness/Sedation (OAA/S) scale
• Time to first request for analgesia
• Total analgesic consumption

There were no differences between groups in sedation scores or hemodynamic measures. Patients in the control bupivacaine-only group had significantly higher pain at baseline. Postoperative pain scores were lower among those who received dexmedetomidine compared to controls at 12 hours (p = 0.027), but there were no differences at any other time point. Time to first analgesic request was significantly longer in the dexmedetomidine and fentanyl group, and this time was longer in both dexmedetomidine groups compared to the control (p < 0.001). Total tramadol consumption also was lower among those who received dexmedetomidine (p < 0.001). In general, there was a lower prevalence of adverse effects among those receiving dexmedetomidine.

The intrathecal administration of 5 mcg dexmedetomidine increased the efficacy and duration of postoperative analgesia. The addition of fentanyl did not have a significant additive effect.

• Small sample (< 100)

The provision of preoperative intrathecal anesthetics and analgesics can improve postoperative pain control. This study demonstrated that the addition of dexmedetomidine to bupivacaine improved the postoperative effectiveness and duration of analgesia, resulting in less need for other analgesics. Nurses can advocate for the consideration of this type of approach for patients undergoing major surgery to reduce procedure-related pain.

To evaluate the effects of group therapy on anxiety and depression

Acceptance and commitment therapy (ACT) is described as a type of “third wave” of cognitive behavioral therapy that focuses on values and goals clarification and acceptance-based behavioral strategies and mindfulness processes. Participants were randomly assigned to experimental and control groups. The experimental group had ACT held in eight sessions of 90 minutes during four consecutive weeks. These were provided in a group setting. Study measures were obtained at baseline and after the intervention.

• N= 30
• MEAN AGE = 47.2 years (range = 29-59)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer, but stages varied.  Standard therapy was completed.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Iran

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled trial

• Beck Depression Inventory
• Beck Anxiety Scale

Anxiety and depression scores declined in the experimental group, while increasing in the control group. These differences, however, were not statistically significant (p = 0.000).

Findings suggest that a psychoeducational intervention based on acceptance and commitment therapy can be of benefit in reducing anxiety and depression among women with breast cancer.

• Small sample (less than 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: There is no description of the control condition, and apparently no attentional control. Baseline anxiety and depression scores were higher in the experimental group, and other studies have shown that interventions can have a greater effect for those with higher anxiety and depression initially.

This type of psychoeducational intervention may be of benefit to reduce anxiety and depression in women with breast cancer. It is not clear to what extent results here were an effect of the protocol used or the participation in group sessions, which could have been supportive.  Psychoeducational interventions are generally low-risk and relatively low-cost approaches that may be of benefit to patients.

• FINAL NUMBER STUDIES INCLUDED = 60 
• TOTAL PATIENTS INCLUDED IN REVIEW: Not able to determine the total number of patient is this review
• KEY SAMPLE CHARACTERISTICS: Characteristics spanned a wide variety of diagnoses that included cancer, dyspepsia, and gastroesophageal reflux disease. 

Twelve studies looked at rikkunshito’s effects on anorexia in subjects with cancer. Three studies utilized human subjects. These studies looked at patients receiving cisplatin for unresectable/relapsed gastric cancer and gemcitabine for pancreatic cancer with ascites. The results showed that rikkunshito improved anorexia in 19 patients receiving docetaxel/5-FU/cisplatin. When evaluated for nausea, mood, and activities of daily living, scores in these metrics were significantly lower in the rikkunshito group compared to controls. In a crossover design, the effects of rikkunshito on cisplatin-induced anorexia were studied, which demonstrated an increase in oral intake, no decrease in ghrelin levels, and a lower grade of anorexia in patients taking rikkunshito compared to when those patients were not taking rikkunshito. In a retrospective study of 39 patients who were treated with gemcitabine, improvement in anorexia was noted as well as increased survival. In the studies of anorexia, models utilizing animals revealed improved food intake with increased ghrelin levels that were noted along with improved survival. Rikkunshito was combined with various western agents in these studies and was shown to improve gastrointestinal side effects/symptoms and not affect the effects of the agents (e.g., SSRIs, antimicrobial agents, antiparkinson agents). There was no indication for any effect on CYP isoenzymes or P-gp.

Rikkunshito combined with western anticancer medicines has been shown to improve appetite by increasing ghrelin levels, thereby reducing anorexia.

All studies were conducted in Japan where Kampo medicine is used frequently and is readily available for use. There were very few human studies conducted; the majority of studies utilized animal subjects.

Rikkunshito appears to be a promising medication to improve anorexia, but there is inadequate data to recommend this agent at this time. Additional studies utilizing human subjects and a variety of anticancer medications as well as cancer diagnoses need to be conducted. In addition, studies are needed to evaluate the use of rikkunshito for the management of gastrointestinal symptoms in other diagnoses (e.g., depression, Parkinson’s, gastroesophageal reflux disease).

To evaluate the use of honey and royal jelly on fatigue in individuals undergoing treatment for cancer

In this study, the intervention group received processed honey and royal jelly. The control group received pure honey. Each group consumed 5 ml twice daily for four weeks. Assessments of outcome measures were completed at baseline, two weeks, and four weeks after the intervention.

• N = 52   
• AGE = 54.8 years
• MALES: 40%, FEMALES: 60%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy, other
• KEY DISEASE CHARACTERISTICS: Solid tumors (breast, prostate, and gastrointestinal related)

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Iran

PHASE OF CARE: Active antitumor treatment

This was a double-blind, randomized, controlled clinical trial in which participants were randomized to one of two groups (intervention group = processed honey and royal jelly; control group = pure honey).

Visual analog scale for fatigue (VAS-F) and fatigue severity scale

Numeric fatigue ratings in the intervention group were significantly less than those reported in the control group (p < 0.001) at the week 2 and week 4.

The use of processed honey and royal jelly to manage cancer-related fatigue warrants further investigation into the mechanisms and efficacy of use.

Small sample (< 100)

No side effects were noted in this study with the use of a dietary supplement. The results suggested that honey with royal jelly may help alleviate chemotherapy-related fatigue.

A self-paced, progressive, home-based exercise program (walking exercise versus usual care) was used. Individualized walking was based on age, level of fitness, and history of exercise. The program was a brisk, incremental, 20- to 30-minute walk, followed by a 5-minute slow walking cool-down, four to five times per week for six weeks. Outcomes were exercise, fatigue, physical functioning, emotional distress, and sleep.

• The sample was comprised of 46 females.
• Mean age was 49 years.
• Of the patients, 87% were Caucasian and 72% had stage I breast cancer and were undergoing radiotherapy.

• Two university teaching hospitals
• Instructions were given at the institution, but the intervention was performed at home.
• Southeastern United States

Patients were undergoing the active treatment phase of care.

The study used a two-group, controlled, pre-/posttest experimental design.

• Symptom Assessment Scale (SAS)
• Piper Fatigue Scale (PFS)
• 12-minute walk test
• Sociodemographic information

Women who exercised regularly reported less difficulty sleeping than the control group.

• Only the first patient received random assignment. Subsequent patients were alternately assigned to the usual care or exercise groups.
• A diffusion effect was possible for exercisers in the usual care group.
• The study had a small sample size.
• The study lacked control over the intervention in the home.
• Patients had to adhere to a five-day-a-week regimen.
• Exercise physiologist consultation is needed.
• RNs must be trained in delivering the intervention.
• The study should be supervised by a principal investigator.

Caution:  maintain safety while exercising.

To investigate the effect of combined decongestive therapy (CDT) and pneumatic compression pump on upper-limb lymphedema indicators (circumference, volume, and shoulder range of motions) in patients with breast cancer-related lymphedema

The intervention was completed in two phases. In the first phase, the therapeutic phase, CDT and compression pumping was performed by the one researcher at the clinic. Each session included manual lymphatic drainage for 30–40 minutes. The affected upper limb was then placed in the compression pump for 15 minutes and bandaged with multilayer compression bandages, followed by remedial exercises. Also during the first phase, written and verbal information were given regarding skin and nail care, care of the bandaging and practical training in manual lymphatic drainage, how to bandage the upper limb, and remedial exercises. In the second phase, the maintenance phase, patients performed CDT daily at home. The first phase included three weekly sessions for four weeks; each session lasted 60–90 minutes. The second phase included daily CDT for four weeks. Patients were evaluated at baseline and four and eight weeks after the intervention.

• The study sample (N = 21) was comprised of 100 femal patients with breast cancer-related upper-limb lymphedema.
• Mean age ranged from 35–70 years.
• All patients were at least one year since axillary node dissection and had not received CDT.

The study took place at the Shahid Mottahari Therapeutic Center in Shiraz, Iran.

The study has clinical applicability for late effects and survivorship.

The study used a pre-post design.

• Measuring tape was used to measure circumference.
• Volume was measured using water displacement.
• Range of shoulder joint motions was measured using a goniometer.

The mean difference in circumference of the two upper limbs in all areas at different phases of study decreased significantly (p < 0.05). The difference in mean volume between the two upper limbs four and eight weeks after the intervention were smaller than before the intervention (p < 0.001). Mean range of flexion (p < 0.001), extension (p < 0.004), abduction (p < 0.001), and external rotation (p < 0.001) increased four and eight weeks after the intervention.

Combined CDT and pneumatic compression pump reduce mean volume and mean circumference of the breast cancer-related upper-limb lymphedema and increase shoulder joint range of motion.

• The sample size was small, with less than 30 participants.
• The study had a risk of bias because of no control group or random assignment.
• Unintended interventions or applicable interventions were not described and would influence results.
• The author did not provide the time (how many minutes) of daily CDT performed by patients in the second phase.
• No information is provided regarding the compression pump.  

Nurses can play a key role in providing rapid and timely interventions to reduce the severity of lymphedema (e.g., CDT skills and use of compression pump) and patient education regarding self-care and self-management of lymphedema.

Random assignment occurred in a 2:1 ratio to the intervention group or control group after stratification by treatment (chemotherapy or antiestrogen therapy). The yoga intervention consisted of twelve 1.5-hour weekly classes held at three locations within the cancer center. Participants were permitted to attend more than one class per week, with such activity documented. The yoga intervention was developed for use with patients with breast cancer by one of the study authors who was an oncologist and a certified yoga instructor. The intervention was based on Hatha yoga stretches and poses, breathing exercises, and meditation. All exercises were performed in a seated or reclined position. Patients were asked to practice yoga at home daily and were given an audiotape/CD for guidance in their home practice.

• Oncology outpatients were recruited from oncology clinics at a university medical center and from several private clinics between 2001 and 2005.
• The sample was comprised of 128 patients with breast cancer.
• Mean age was 54.81 years (range 28–75).
• Of the patients, 42% were Black, 31% were Hispanic, 23% were White, 76% had high school education or less, 69% were not married, 45% had stage I, and 53% had undergone lumpectomy.
• Of 164 women with breast cancer who consented, 128 (78%) completed the baseline and main follow-up (three-month) assessments.

Patients were undergoing the active treatment phase of care.

The study used a randomized, wait-list control design.

Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)

No significant difference was found in fatigue change scores from baseline to three-month follow-up between the intervention and wait-list control groups. Both groups were significantly fatigued compared with normative values for the FACIT-F. Subanalysis of the change scores only among the subgroup of patients not on chemotherapy (n = 71) also failed to demonstrate an effect of the yoga intervention on fatigue. However, adherence analysis suggested that participants in the intervention group who were highly adherent with the yoga intervention had significantly improved in fatigue compared with those in the intervention group who were less adherent with the yoga intervention. The primary reason for attrition was lost to follow-up (15%), with attrition similar between the intervention (22%) and control (21%) groups. Those who dropped out were significantly more likely to be younger.

• The study had a small sample size (intervention group, n = 84).
• One can speculate that the effects of the intervention may have been obscured by the relatively high level of fatigue of the participants. In support of this possibility is the fact that fatigue was a statistically significant predictor of yoga class attendance.
• Yoga may be less feasible for patients who are on active treatment with radiation or chemotherapy or those who are already fatigued—adherence analysis revealed that greater fatigue, younger age, receiving radiotherapy, and not being on antiestrogen therapy together explained 40% of the variance in attendance at weekly yoga classes.

To determine whether adding olanzapine to current standard antiemetic therapy could reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve patients’ quality of life (QOL) during chemotherapy

• N = 44 
• MEAN AGE = 63 years (olanzapine group), 55 years (control group), non-significant difference p = .06
• MALES: 50%, FEMALES: 50%
• KEY DISEASE CHARACTERISTICS: Cancer patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) with an Eastern Cooperative Oncology performance status of 0–2.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had not experienced NVR in the 24 hours before the start of the trial, had not scheduled to receive concurrent abdominal radiation therapy, had no history of DM, were not receiving other antipsychotic agents, and were not hypersensitive to olanzapine.

• SITE: Multi-site  
• SETTING TYPE: Inpatient  
• LOCATION: Sapporo, Hokkaido, Japan

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blind, placebo-controlled trial

• Primary endpoint: Total control (no vomiting, no use of rescue medications, and maximum nausea of < 5/100 mm)
• Secondary endpoint: Functional Living Index–Emesis (FILE) questionnaire scores on days 0 and 6
• Additional: QOL (FLIE), amount of diet intake during CTx, satisfaction, complete response (no vomiting, no use of rescue medication), complete control (complete response + nausea < 25 mm/100 mm), and Visual Analog Scale

The olanzapine group achieved better total control (59% overall, 86% in the acute phase, and 64% in the delayed phase) than the control group (23% overall, 55% in the acute phase, and 23% in the delayed phase). The olanzapine group also achieved better complete protection and complete response except for acute phase complete response (p < .05). Furthermore, the olanzapine group experienced better QOL (p < .01), and the olanzapine group indicated that CINV did not affect their daily activities whereas 36% of the control group reported influence of CINV on daily life activities. There were significant differences between the VAS for nausea and satisfaction scores for additional medication. Most of the olanzapine group patients (91%) wished to receive same protocol for future chemotherapy. Dietary intake was better maintained by the olanzapine group with a significant difference on day 2 and days 4–6.

The addition of 5 mg/day of oral olanzapine to standard therapy can reduce the frequency of CINV and improve QOL for patients receiving highly or moderately emetogenic chemotherapy.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (sample characteristics)
• Other limitations/explanation: Age of the olanzapine group was higher than the control (which could have influenced less development of CINV), and other risk factors of the CINV were not taken into consideration. MEC group also received NK1, which is not a standard antiemetic. Combination of palonosetron and olanzapine need to be investigated further, with stratification of emetogenicity of chemotherapy regimen, and the use of first and second generation 5-HT3RA between the two groups (as palonosetron 0.75mg was used in the study).

The addition of olanzapine to standard antiemetics, such as 5-HT3RA, steroids, and NK1RA, could achieve better control of CINV, especially for the delayed phase, with additional benefit in terms of QOL and less change in dietary intake. However, caution needs to be exercised in interpreting the result as the study allowed NK1 for the MEC, had age difference between the olanzapine and control group, and did not take risk factors of CINV into consideration, and the palonosetron dose of 0.75mg was higher than antiemetic recommendations.

To evaluate the safety, efficacy, and pharmacokinetic profile of a 12.5 mcg/hour transdermal matrix fentanyl patch used to manage the persistent pain of patients with cancer

On study day 1, the patch was applied. It was replaced every 3 days for a 10-day period. All patients initially received the 12.5 mcg/hour  dose. At the time of patch replacement, the dose could be increased according to pain intensity and rescue medication used. Use of opioid receptor antagonist analgesics and other opioid medication was prohibited. Patients received fast-acting morphine for breakthrough pain. Serum fentanyl levels were measured on days 4, 7, and 10. Physicians assessed global effect on day 10 or at the time of study discontinuation. Patients provided a global assessment on days 1, 4, and 7.

• The sample was composed of 85 patients.
• Of all patients, 75% were age 60 or older. The age range was 40 to older than 70.
• Of all patients, 47% were female and 53% were male. 
• Diagnoses included gastrointestinal cancer (which 40% of patients had), gynecologic cancer (10.6%), and hepatobiliary cancer (5.9%). The sample contained a mix of other cancer sites. At baseline, 69.4% of patients were taking oxycodone, 29.4% were taking morphine, and 1.2% were undergoing fentanyl injections for pain control.

• Single site
• Outpatient
• Japan

Open-label prospective trial

• Five-point scale (5 = very satisfied, 1 = very dissatisfied), to measure patient's global assessment of pain
• Dichotomous scale (1 = effective, 2 = ineffective), to measure physicians' global assessment
• Eastern Cooperative Group (ECOG) performance status

In 78 patients, a total of 316 adverse events occurred. The most frequent adverse events were nausea (which 36% of patients experienced), somnolence (30.2%), vomiting (25.6%), diarrhea (19.8%), constipation (16.3%), pyrexia (12.8%), and insomnia (10.5%). Three patients experienced evere adverse events: dyspnea and respiratory failure. Authors observed 12 cases of skin irritation at the patch site. Of all patients, 96% reported that they were satisfied or very satisfied with the 12.5 mcg/hour transdermal matrix fentanyl patch. According to global assessment by physicians, the 12.5 mcg/hour transdermal matrix fentanyl patch was as effective as the other treatments in 98% of cases.

The 12.5 mcg/hour transdermal matrix fentanyl patch appears to be a reasonable means of controlling persistent cancer pain in patients switching from low-dose morphine or oxycodone.

• The study had a small sample, with fewer than 100 participants.
• The study had a risk of bias due to no control or comparison group.
• Authors provided no specific severity rating of adverse effects.
• Distribution of final fentanyl doses associated with efficacy was not provided.
• Authors did not report how adverse events were defined or recorded.
• Authors did not report the use rescue medications.
• Authors stated the results of a visual analog scale over time; however, they did not describe the scale or how it was used.

No firm conclusions can be drawn from this study.

To determine the impact of palonosetron on chemotherapy-induced nausea and vomiting (CINV) in patients with lymphoma receiving CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone or prednisolone) chemotherapy

This single-arm study evaluated palonosetron in patients with lymphoma. Patients received 0.75 mg palonosetron as an IVP 30 minutes prior to chemotherapy. No antiemetics were allowed within 48 hours prior to treatment. Patient were further restricted from taking any antiemetics unless they experienced symptoms of CINV for 168 hours after treatment. There is no mention of other antiemetics that were used. It is unclear if the data were collected beyond one cycle. Patients were chemotherapy naïve but could have received rituximab.

• N = 54/50   
• AGE = 23–75 years
• MALES: 46%, FEMALES: 54%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma  
• OTHER KEY SAMPLE CHARACTERISTICS: Stage of disease, alcohol use, smoking, motion sickness, morning sickness, previous radiation

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Single-arm study conducted at five hospitals

Patients maintained an assessment diary from 0–168 hours after chemotherapy. Questionnaires also assessed drinking history, motion sickness, pregnancy history, and emesis during pregnancy. The primary end point was the occurrence rate of nausea, vomiting, and anorexia, which were measured using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Secondary end points evaluated these symptoms during the acute and delayed phases of CINV, as well as frequency of rescue medication use. The patients’ physicians scored the CTCAE based on the patients' diary.

Four patients became ineligible because of steroid administration dosing and new central nervous system metastasis. Overall occurrence of nausea and anorexia of any grade for the overall phase was 56% for nausea, 62% for anorexia, and 12% for vomiting. Six patients experienced vomiting. Half of these patients experienced vomiting after completion of the five days of steroids (part of the chemotherapy regimen). Patient characteristics were evaluated using univariate analysis, which did not show any association between patient parameters and nausea or vomiting in the overall phase. Anorexia, however, was significantly associated with both sex (p < 0.001) and drinking history (p < 0.001).

Females were more likely to experience anorexia, and should be considered for NK-1 inhibitors. There was an association of nausea in the acute phase leading to the development of delayed anorexia. Clinicians should also be more attentive to development of CINV in the delayed phase after 120 hours.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Provider scoring diaries, with possible prejudice

Nurses need to consider delayed CINV in CHOP chemotherapy, particularly after patients have completed the steroid component of their treatment.