Madeddu, C., Dessi, M., Panzone, F., Serpe, R., Antoni, G., Cau, M.C., . . . Mantovani, G. (2011). Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib +/- megestrol acetate for patients with cancer-related anorexia/cachexia syndrome. Clinical Nutrition, 31, 176–182.
To compare the efficacy and safety of a two-drug combination (including nutraceuticals) with carnitine and celecoxib (arm 1) versus megestrol acetate (arm 2) for the treatment of cancer anorexia and cachexia syndrome
No dietary restrictions were placed on participants. Polyphenols (2 tabs, 300 mg/day), lipoic acid (300 mg/day), carbocystine (400 mg/day), vitamin A (30,000 IU/day), and vitamin C (500 mg/day) were administered orally to all patients. Patients were then randomized to treatment arms: arm 1, L-carnitine (4 g/day) + celecoxib, or arm 2, l-carnitine (4 g/day) + celecoxib + megestrol acetate (MA) (320 mg/day). Treatment duration was four months. Measurements were obtained at 4, 8, and 16 weeks. Analysis focused on differences from baseline to 16 weeks. Data were collected from 2009 to 2010. No placebo arm was included for ethical reasons and based on previous research. Planned study duration was four months.
A phase III, randomized, two-group, non-inferiority trial design was used.
Primary endpoints: There was no significant difference (based on t test) between arms for LBM and physical activity. DEXA and CT of L3 significantly increased at 16 weeks from baseline in both arms. BIA did not change in either arm. There were no significant changes in physical activity in either arm. The six-minute walking test improved in both arms, and grip strength did not change significantly in either arm. REE, fatigue, Eastern Cooperative Oncology Group score, and prognostic score decreased significantly in both arms. Body weight did not change significantly in arm 1 but did increase in arm 2 (p = 0.052, which was not significant but on the border and trending). Appetite was reported as improved significantly in both arms (p < 0.05). Fatigue scores were improved significantly in arm 1 after treatment (p = 0.036). Survival measurements did not change and were not significantly different between groups. Two patients reported grade 3 diarrhea.
No significant differences were found in patients based on the intervention arm.
A multimodal approach may help to improve anorexia and cachexia in patients with cancer. More work focused on patient-reported outcomes, safety, and adherence is needed. Specific description of how appetite is assessed should be included in studies reporting this outcome measure.
Butow, P., Price, M.A., Shaw, J.M., Turner, J., Clayton, J.M., Grimison, P., . . . Kirsten, L. (2015). Clinical pathway for the screening, assessment and management of anxiety and depression in adult cancer patients: Australian guidelines. Psycho-Oncology, 24, 987–1001.
PHASE OF CARE: Multiple phases of care
No information is provided regarding literature retrieved, quality of evidence, or how the evidence was used to develop the guidelines provided.
Outlines relevant healthcare provider roles. Identified the following assessment tools for use: Edmonton Symptom Assessment Scale, the NCCN's Distress Thermometer, and the Hospital Anxiety and Depression Scale. Provides a stepped path of interventions based on ongoing monitoring of symptoms and effectiveness of previous interventions. Recommendations for initial intervention are patient education (in-person or online) and brief emotional support. Ongoing interventions for those with cancer-related anxiety and depression include coping skills training, relaxation skills, communication skills, mindfulness, and a variety or psychological therapies.
Despite an extensive review process for guidelines, as well as input from stakeholders, there is little information on the evidence base for the recommendations provided.
This guideline outlines recommended providers, and nurses are not specifically outlined as recommended providers in the written pathway other than as “other appropriately trained staff,” although nurses are identified as having roles in screening, assessment, and educational and counseling types of roles. This guideline provides no new information and does not directly provide the evidence base on which recommendations are based. The guideline suggests more limited roles for nurses than has been demonstrated in relevant research.
Butler, L.D., Koopman, C., Neri, E., Giese-Davis, J., Palesh, O., Thorne-Yocam, K.A., . . . Spiegel, D. (2009). Effects of supportive-expressive group therapy on pain in women with metastatic breast cancer. Health Psychology, 28, 579–587.
To examine the effect of supportive-expressive group therapy using hypnosis in patients with metastatic breast cancer experiencing pain and to explore the interaction between hypnotizability and pain experience in women trained to use hypnosis
Baseline pain, distress, coping, social support, physical activity, and immune and endocrine function were evaluated, and patients were randomized by the project director and a research nurse using an adaptive randomization biased coin-design method. Treatments were conducted at each of the three sites weekly for 90-minute sessions. Group size varied from 3–15 participants because of rolling recruitment and participants dying. Each supportive-expressive therapy session was co-led by two psychotherapists; among these were a psychiatrist, psychologists, and social workers. Themes emerging in these sessions were fears of dying and death, including dealing with the deaths of group members, reordering life priorities, improving support from and communication with family and friends, integrating a changed self and body image, and improving communication with physicians. A hypnosis exercise ended each session, and participants were instructed to practice this several times a day and any time the pain was noticeable or increased. The control group members were offered self-directed education and a year membership to a consumer health library in their community. Post-baseline assessments were every four months for the first year and then every six months after.
Analysis of covariance on change in intensity of current pain showed statistical significance (P = .001) in those in the treatment group versus the education only group. Those who received therapy and education showed a smaller increase in the intensity of current pain than the control (education alone) (P = .034). Those who had a greater intensity of current pain and suffering at baseline experience a great decrease in intensity (P = .001), whereas those for whom baseline pain was less experienced increases in intensity. No statistically significant relationships associated with hypnotizability were found across recruitment sites, and hypnotizability did not show an interaction with treatment. The treatment effect was not significant with the baseline level of pain but still predicted a greater decrease in pain (p = .008). Those who reported the most pain at baseline showed a decrease in frequency of pain, whereas those who reported least frequent pain at baseline showed an increase in frequency (p = .001). Constant pain at baseline showed the greatest reduction in constant pain, whereas those who did not report constant pain showed an increase in constant pain (p = .001). Treatment did not have an effect on constant pain. Highly hypnotizable women reported greater use of hypnosis exercises for controlling nausea and vomiting, for management of stress and anxiety, and for comfort versus low hypnotizable women.
Hypnosis and group sessions can be successful in reducing pain and suffering—more specifically for those with high hypnotizability—and potentially could be used to help control other symptoms in metastatic breast cancer or even other cancers. Patients without constant pain or with low current pain seemed to show an increase in constant pain and frequency. Low hypnotizability was also a less desirable trait in controlling symptoms; however, these individuals were found to have used hypnosis less frequently and may not have experienced maximum benefit. This method could be utilized as an adjunctive to treat symptoms other than pain; however, this study addressed pain only.
Nurses may want to become educated in hypnosis as an adjunctive therapy to educate patients to utilize this method in controlling pain. Additionally, nurses may want to refer those particularly having a difficult time with symptom management to a supportive-expressive therapy group rather than providing only educational material to patients with metastatic breast cancer. Nurses also must keep in mind that group intervention and hypnosis may not be successful or appealing to all patients and certain characteristics and hypnotizability impact the success of treatment.
Butler, J.M., Jr., Case, L.D., Atkins, J., Frizzell, B., Sanders, G., Griffin, P., … Shaw, E.G. (2007). A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy. International Journal of Radiation Oncology, Biology, Physics, 69(5), 1496–1501.
This study was conducted to assess the effect of prophylactic d-methylphenidate HCl (d-MPH), a central nervous system stimulant, on quality of life and cognitive function in patients with brain tumors undergoing radiation therapy.
The treatment group received a starting dose of 5 mg twice daily of d-MPH; this was escalated to a maximum of 15 mg twice daily. Patients were stratified by tumor type (primary versus metastatic), treatment (radiation therapy alone versus radiation therapy plus chemotherapy), and Karnofsky Performance Status (< 90 versus 90), and were randomized within strata to one of the two treatment arms.
This was a randomized, double-blind, placebo-controlled study.
There was no difference in cognitive functioning at baseline, end of radiation therapy, or at 4, 8, and 12 weeks after brain radiation therapy. No difference in fatigue or quality of life was observed.
Prophylactic use of d-MPH in patients with brain tumors undergoing radiation therapy did not result in an improvement in cognitive functioning, quality of life, or fatigue.
Buss, T., de Walden-Gałuszko, K., Modlińska, A., Osowicka, M., Lichodziejewska-Niemierko, M., & Janiszewska, J. (2010). Kinesitherapy alleviates fatigue in terminal hospice cancer patients-an experimental, controlled study. Supportive Care in Cancer, 18, 743–749.
To evaluate the effect of physical exercise on terminally ill patients with cancer.
Patients in the exercise group exercised three times a week for 20 to 30 minutes for a three- to four-week period. The schedule of exercises was individually planned by a physiotherapist. Study outcome measures were obtained at baseline, weekly, and at the end of the study. No information was provided regarding the control group procedures.
Patients were undergoing end of life care/end of life and palliative care phase of care.
This was a two-group comparative trial – no information was provided on whether patients were randomly assigned.
There were no apparent effects on outcomes during the first two weeks. By week 3, mean VAS intensity of fatigue declined in the exercise group from 6.5 to 5.5. In the control group, fatigue increased from 6.5 to 7.5 (ANOVA; p < 0.001). Physical symptoms tended to decline slightly in the exercise group and increase slightly in the control group, with changes ranging from 0.1 to .05 (p < 0.05). There were no observable effects on quality of life scores from the symptom checklist data.
Results suggested that individualized exercise can be beneficial for fatigue in terminal patients with cancer.
The study did not provide strong evidence for the effectiveness of exercise due to multiple issues in this report and the small measured changes seen. Findings suggested that exercise may be beneficial in terminally ill patients and showed that there were no apparent adverse effects from the activity provided to these patients.
Burris, H.A., III, Belani, C.P., Kaufman, P.A., An, G., Schwartzberg, L.S., Paroly, W.S., . . . Saven, A. (2010). Pegfilgrastim on the same day versus next day of chemotherapy in patients with breast cancer, non-small-cell lung cancer, ovarian cancer, and non-Hodgin's lymphoma: Results of four multicancer, double-blind, randomized phase II studies. Journal of Oncology Practice, 6, 133–140.
The purpose of the study was to compare severe neutropenia duration and incidence of febrile neutropenia in patients getting chemotherapy with pegfilgrastim on the same day or 24 hours later.
Four studies were analyzed separately, and data were not compiled for overall analysis across cancer types. In all settings, patients were randomly assigned to either receive pegfilgrastim 6 mg on the last day of the chemotherapy cycle and placebo injection 24 hours later, or placebo on the last day of the cycle and pegfilgrastim 6 mg 24 hours later. Anti-infective prophylaxis was not allowed. Incidence of grade 4 neutropenia was the primary study endpoint, and patients were included and analyzed for one cycle. Complete blood counts were obtained weekly for each chemotherapy cycle.
Active antitumor treatment
Randomized, double-blind placebo controlled
Not stated
In the breast study, grade 4 neutropenia was reported in 93% of same day patients and 78% of next day patients. Mean duration of severe neutropenia was 1.2 days longer in the same day group. In the lymphoma study, severe neutropenia was reported among 86% of same day pegfilgrastim patients and 64% of next day patients. Mean duration of severe neutropenia was 0.9 days longer in the same day group. Incidence of febrile neutropenia was essentially the same in both groups. In the lung cancer group, only 5% of patients experienced severe neutropenia. Analysis of the ovarian group was not done due to study closure prior to obtaining a sufficient sample. Authors report that noninferiority statistical analysis showed that next day pegfilgrastim was not inferior to same day pegilgrastim.
Findings suggest that different timing of pegfilgrastim administration within a two day window may not make a difference in incidence of severe neutropenia in these patient groups.
This report provides some information from four studies to examine differences in timing of administration of colony-stimulating factors. The most beneficial and cost-effective formulations, dosages, and timing have not been determined. This report has several limitations in study design and results reported.
Burrai, F., Micheluzzi, V., & Bugani, V. (2014). Effects of live sax music on various physiological parameters, pain level, and mood level in cancer patients. Holistic Nursing Practice, 28, 301–311.
To examine the effects of live saxophone music in patients with cancer
Patients were randomly assigned to music or control groups. A holistic nurse played the saxophone music for patients in a hospital room with the patient lying in bed and the door closed. Sound could not be heard in other rooms. Patients chose five or six musical pieces of different styles from a large playlist. The patient listened for about 30 minutes, then returned to the regular hospital room. The intervention was given weekly for four weeks. Control group patients had a 30-minute rest period. Physiologic parameters and mood and pain data were obtained after the intervention or rest period weekly. Patients were receiving chemotherapy in an inpatient setting.
Single-blinded, randomized, controlled trial
Oxygen saturation in the experimental group increased from an average of 98 to 99 postintervention. Pain levels in the experimental group decreased on average from 1.8 (SD = 1.9) to 0.7 (SD = 1.1, p = 0.001). Mood changed from a 5 on average to 2.2 in the experimental group (p = 0.000). There were no significant changes in the control group. Differences between the groups were not significant for pain or mood.
The findings of this study did not show a significant effect on pain from live music compared to usual care. Listening to live music was associated with improved mood.
The findings of this study suggest that listening to live music can improve patients’ moods. This study did not provide strong evidence for the effects of music on pain, and the study report had multiple limitations. Music interventions are low-risk and may be helpful for some patients. The intervention can be provided in multiple ways in multiple settings although the use of live music therapy can be more limiting because of available settings.
Burns, D.S., Azzouz, F., Sledge, R., Rutledge, C., Hincher, K., Monahan, P.O., & Cripe, L.D. (2008). Music imagery for adults with acute leukemia in protective environments: A feasibility study. Supportive Care in Cancer, 16, 507–513.
To determine the feasibility and possible benefits of a music imagery intervention for hospitalized patients with acute leukemia or high-grade non-Hodgkin lymphoma
Study patients completed baseline self-report instruments to assess affect, anxiety, and fatigue. Participants were then randomized to receive standard care or standard care plus music imagery. Standard care was hospitalization in a HEPA-filtered room with restricted visitor access and supportive medical care. A board-certified music therapist provided music imagery sessions. Sessions included relaxation and music imagery and were designed to provide participants with an opportunity to practice music imagery techniques, provide a successful music imagery experience, and answer any questions. When the initial session was complete, the therapist provided a CD with four 20-minute music imagery exercises as well as a CD player. Participants were encouraged to use the exercises at least once a day, and more frequently if they could. Participants used a journal to record how many exercises were used and their perceived effectiveness of the music therapy exercises. During therapist visits, patients could ask questions, change music imagery selections, and experience a therapist-led music imagery session. Music for the study included light classical and new age music chosen by the therapist based on assessment of the patients’ musical preferences and current emotional state and energy level. Sessions by the therapist occurred within three days of admission and twice a week during the hospital stay, up to four weeks.
Patients were undergoing the active treatment phase of care.
A randomized controlled trial design was used.
Overall, 72% of therapy sessions were completed when accounting for study dropouts. No one completed the music imagery journal, due to feeling too sick or not remembering. Forty-nine percent completed an average of 60% of the measurement instruments. Analysis of mean scores over time, using repeated measures ANOVA, showed that both study groups improved in terms of greater positive affect, less negative affect, less fatigue, and less anxiety (p < 0.001). There were no differences in these results between study groups. Within those patients with low negative affect at baseline, those who received the therapy had lower anxiety at week 4 or hospital discharge than those in the control group.
Music imagery therapy is feasible in this population. Only those patients who had low initial negative affect demonstrated a potential benefit of the intervention in terms of lower anxiety at the end of the study period. Anxiety and fatigue declined over time in all patients.
Results suggest that this type of intervention may only be of benefit in a select group of patients who are not as severely ill and do not have a high negative affect. The drop-out rate also suggests that this is a type of intervention for which participation and effect are highly dependent upon the patients’ preferences and interest in involvement. Findings suggest that once patients acclimate to the hospital environment, anxiety, fatigue, and negative affect decline, suggesting that nursing attention to helping patients with this acclimation may be most important in addressing these patient problems.
Burns, D. S., Azzouz, F., Sledge, R., Rutledge, C., Hincher, K., Monahan, P. O., & Cripe, L. D. (2008). Music imagery for adults with acute leukemia in protective environments: a feasibility study. Supportive Care in Cancer, 16, 507–513.
To evaluate the efficacy and feasibility of music imagery.
The intervention involved 45-minute sessions with a music therapist occurring twice weekly during a four-week hospital stay. The intervention consisted of education about how to use music imagery exercises together with the opportunity to practice music imagery techniques and experience a successful music imagery encounter. The music therapist chose music for each specific patient based on an assessment of the patient’s musical preferences, current emotional state, and energy level. After the session, the patient was provided with equipment to play CDs containing music imagery exercises, and patients were encouraged to use the CDs at least daily during their hospital stay.
Patients were undergoing the active treatment phase of care.
This was a randomized, controlled trial.
The intervention showed no effect on fatigue.
Burnham, T.R., & Wilcox, A. (2002). Effects of exercise on physiologic and psychological variables in cancer survivors. Medicine and Science in Sports and Exercise, 34, 1863–1867.
The intervention was lower-body aerobic exercise three times a week for 10 weeks in groups. The three groups were low-intensity exercise, moderate-intensity exercise, and control.
The study reported on a sample of 18 patients with cancer recovering from treatment.
A randomized controlled trial design was used.
There was significant decrease in anxiety pre- and post-study (p = 0.011) but not compared to the control group versus findings of decreased anxiety in the exercise group.