Midtgaard, J., Rørth, M., Stelter, R., Tveterås, A., Andersen, C., Quist, M., . . . Adamsen, L. (2005). The impact of a multidimensional exercise program on self-reported anxiety and depression in cancer patients undergoing chemotherapy: A phase II study. Palliative and Supportive Care, 3, 197–208.
The intervention was a six-week, nine-hour weekly group intervention of high (exercise) and low (massage) intensity. “Talking time” also was included. A trained nurse and physiotherapist administered the intervention.
Denmark
A prospective follow-up design was used (one group, pre/post-test).
Anxiety and depression scores improved (p < 0.001). Patients who were physically nonactive improved more on the HADS anxiety subscale than those in the active group. Women improved more on the HADS anxiety subscale than men.
Michael, M., Brittain, M., Nagai, J., Feld, R., Hedley, D., Oza, A., … Moore, M.J. (2004). Phase II study of activated charcoal to prevent irinotecan-induced diarrhea. Journal of Clinical Oncology, 22(21), 4410–4417.
In cycle 1, 28 patients received irinotecan plus 1,000 mg oral-activated charcoal (AC) plus 25 ml water the evening before irinotecan and then three times per day for 48 hours after, on an empty stomach. In cycle 2, 24 patients received irinotecan without AC.
This study reported on 52 patients with advanced colorectal cancer receiving 125 mg/m2 irinotecan weekly for four weeks with two weeks of rest.
This was a prospective, nonrandomized trial; patients served as their own controls.
Any statistical comparison in the efficacy parameters defined in the trial would be associated with large confidence intervals.
This was an exploratory trial with small patient numbers; results are hypothesis-generating and require additional confirmation in a larger study.
Meyers, F.J., Carducci, M., Loscalzo, M.J., Linder, J., Greasby, T., & Beckett, L A. (2011). Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: Simultaneous care educational intervention (SCEI): linking palliation and clinical trials. Journal of Palliative Medicine, 14(4), 465–473.
To examine effects of a standardized cognitive-behavioral educational intervention on quality of life (QOL) of patients and their caregivers
Patients designated one caregiver as their coparticipant in the study. Dyads were randomly assigned to intervention or standard care control groups. Those in the intervention arm received a copy of The Home Care Guide for Cancer and participated in three educational sessions with a trained educator. The first session was up to seven days prior to or on the day of entry into a clinical trial. Two additional sessions were done within the next 30 days. Sessions were used to reinforce learning by focusing on patient- or caregiver-identified problems. Usual care was not described. Data were collected at baseline and at 30, 60, 90, 120, and 180 days.
A randomized controlled trial design was used.
Approximately 25% of dyads in both groups withdrew from the study by their own choice. Among patients, there was a five-point decline (100-point scale) in QOL over six months, with no difference between study groups. Among caregivers, those in the control group had QOL scores decline more than those in the intervention group (p = 0.02), according to reported predicted decline from baseline. Caregivers did not show any significant changes in problem-solving skills over time in either study group. The intervention was associated with a slower rate of decline in spiritual aspect of the QOL measure. Caregivers overall showed a decrease in rational problem-solving skills over time, and there were no significant differences between groups, suggesting that the slower decline in QOL with the intervention were not likely a direct result of improved problem-solving skills.
Findings show some potential benefits in the intervention group, but as pointed out by the authors, differences were not likely as a result of improved problem-solving skills, which was the emphasis of the intervention. The study does not demonstrate convincing effects of this intervention for caregivers.
The study's drop-out rate suggests that this intervention may not be practical or acceptable because most of these were by individual participant choice. The study does not provide convincing evidence of effectiveness of this intervention on quality of life for patients or caregivers.
Meyers, C. A., Weitzner, M. A., Valentine, A. D., & Levin, V. A. (1998). Methylphenidate therapy improves cognition, mood, and function of brain tumor patients. Journal of Clinical Oncology, 16(7), 2522–2527.
This study was conducted to test whether methylphenidate (MPH) treatment would improve neurobehavioral functioning in patients with malignant glioma.
Participants were administered 5 mg of MPH daily, increasing dosage by 5 mg twice daily until a response or dose-limiting toxicity was noted.
The study had a pre- and post-test design.
Objective improvements were observed in psychomotor speed, memory, visual-motor function, executive function, and motor speed and dexterity (all p < 0.05). Subjective improvements in improved energy, improved ability to ambulate, better concentration, and brighter mood were reported.
There was a significant improvement noted in cognition that cannot be explained by improved mood or use of glucocorticoids. The authors suggest that stimulants such MPH improve motivation and drive.
Meyer-Hamme, G., Beckmann, K., Radtke, J., Efferth, T., Greten, H.J., Rostock, M., & Schroder, S. (2013). A survey of Chinese medicinal herbal treatment for chemotherapy-induced oral mucositis. Evidence-Based Complementary and Alternative Medicine: ECAM, 2013, 284959.
PHASE OF CARE: Active treatment
All reviewed studies reported positive effects of Chinese herbal treatment for chemotherapy-induced oral mucositis.
Additional well-designed RCT studies are needed, especially to look at the mechanism of action for each herbal remedy. Due to poor design in terms of treatment and control groups, it was almost impossible to evaluate which parts of the treatment concepts are responsible for the measured effects in the reviewed trials.
Some studies used more than one herbal treatment with different routes of administration; therefore, it was difficult to determine which agent may have been more effective in treating oral mucositis. In general, most trials had a poor design.
No recommendations for use in clinical practice were made; recommendations were made for further studies. These studies could use placebo capsules or placebo liquids. It also was recommended that future studies decrease the complexity of the treatments in order to determine what treatments were effective.
Merckaert, I., Lewis, F., Delevallez, F., Herman, S., Caillier, M., Delvaux, N., . . . Razavi, D. (2016). Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: A randomized clinical trial comparing the benefits of single-component and multi-component group interventions. Psycho-Oncology. Advance online publication.
To compare the benefits of two interventions on anxiety in women after initial treatment for breast cancer
Women were randomly assigned to study groups in cohorts of 12 patients. One group received 15 sessions of a single-component support intervention, and the other received a 15-session group intervention combining support with psychoeducational interventions focusing on problem-solving skills, optimizing communications and use of personal and social resources, and self-hypnosis. Interventions were delivered in group settings by clinical psychologists following a structured manual. Sessions were audio and video recorded for use in clinical supervision as needed. Psychologists delivered only one type of intervention to avoid contamination. Study measures were obtained at baseline and after the intervention. All instruments were used with dynamic tasks through completion of the Mental Adjustment to Cancer (MAC) Scale followed by 12 minutes of self-relaxation and through completion of the Fear of Cancer Recurrence Inventory (FCRI) followed by a 12-minute guided hypnosis exercise.
PHASE OF CARE: Transition phase after active treatment
A significant group by time effect was observed in the multicomponent intervention compared to controls for state anxiety after self-relaxation (p = 0.006), for anxiety after guided hypnosis (p = 0.013), and for everyday anxiety level (p = 0.005). No differences were reported between groups in HADs scores. Anxiety and depression scores declined over time in both groups (p < 0.001). The item of psychological distress on the FCRI was reduced in both groups over time, with slightly better improvement in the multicomponent intervention group (p = 0.017).
Both supportive and multicomponent interventions were associated with a decline in anxiety and depression scores over time. The findings suggest that the multicomponent intervention was more effective in enabling women to manage their level of anxiety from triggers that could produce anxiety.
Both supportive and multicomponent psychoeducational type interventions were associated with a decline in anxiety and depression over time; however, determining if these changes were associated with the general supportive atmosphere of the group-based intervention is not possible. Anxiety has been shown to decline over time in general as well, without specific intervention. The findings suggest that the combination of self-hypnosis techniques and psychoeducation may enable individuals to manage their anxiety responses more effectively.
Mercier, J., Savard, J., & Bernard, P. (2016). Exercise interventions to improve sleep in cancer patients: A systematic review and meta-analysis. Sleep Medicine Reviews. Advance online publication.
STUDY PURPOSE: To summarize the available evidence regarding the extent to which exercise improves sleep in patients with cancer
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Multiple phases of care
Sleep outcomes improved in 10 studies (47.6%). Interventions included home-based programs, supervised exercise, or a combination of these two approaches. Aerobic and resistance exercise were employed individually or in combination. Meta-analysis of 12 randomized, controlled trials showed no significant effect of interventions compared to control groups.
Analysis showed no clear significant effects of exercise interventions on sleep outcomes among patients with cancer.
Evidence from this analysis does not show an effect of exercise interventions on sleep quality. However, a large body of evidence regarding numerous other benefits of exercise for people with cancer exists. The analysis and most research have included patients who do not necessarily have clinical insomnia, so it would not be expected that interventions would improve sleep. Future research needs to be conducted among patients with clinically relevant insomnia.
Merchant, T.E., Bosley, C., Smith, J., Baratti, P., Pritchard, D., Davis, T., . . . Xiong, X. (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiation Oncology, 2, 45.
To compare an APP-based cream and an aloe vera-based gel to determine effectiveness in preventing and treating radiation dermatitis
The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by the radiation oncologist. Follow-up examinations were done four to six weeks after completion of radiation therapy, with completion of questionnaires and photographs.
The study took place at St. Jude Children’s Research Hospital in Memphis, TN.
The study used a quasiexperimental design in which patients served as their own controls.
Some patients rated the APP cream better in terms of comfort and skin dryness. Grouped NCI CTCAE scores were supportive of APP cream (p = 0.004)
APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.
Merchant, T. E., Bosley, C., Smith, J., Baratti, P., Pritchard, D., Davis, T., … Xiong, X. (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiation Oncology, 2, 45.
To compare an anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.
The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).
St. Jude Children’s Research Hospital, Memphis, Tennessee
The study used a quasiexperimental design. Patients served as their own controls.
The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.
Significant differences in specific variables favoring APP cream were noted in some patients, including:
Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. During RT, there was a difference in CTC scores, favoring the cream (p = 0.004).
APP cream is more effective than aloe vera–based gel for the prevention and treatment of radiodermatitis.
Mercadante, S., Porzio, G., Ferrera, P., Fulfaro, F., Aielli, F., Verna, L., . . . Mangione, S. (2008). Sustained-release oral morphine versus transdermal fentanyl and oral methadone in cancer pain management. European Journal of Pain, 12, 1040–1046.
To compare analgesic efficacy, adverse effects, need of increasing doses, and quality of life in patients with advanced cancer on morphine, fentanyl, and methadone
To compare the cost of pharmacologic pain management
Patients were randomized to morphine, fentanyl, or methadone. Morphine was offered as breakthrough pain medication at one-sixth of the equianalgesic 24-hour dose. Adjuvants were allowed. If the patient experienced poor opioid response or uncontrolled adverse events, he or she was switched to another opioid. Data were collected at weekly intervals for four weeks.
The study has clinical applicability for end-of-life and palliative care.
The study was a randomized controlled trial.
A similar number of patients in each group rotated to other opioids. There were no significant differences in the number of days to achieve dose stabilization, nor where there significant differences in the number of dose changes needed during titration. No differences existed in the PI of the three groups. OEI % was highest in the fentanyl group and significantly lower in the methadone group; 14 patients on methadone did not have a dose change, but 8 required a decrease in the dose and then a subsequent increase. There were no significant differences in quality-of-life scores between groups. Methadone was less expensive.
All three opioids were effective in controlling cancer pain in some patients. Adverse event profiles were similar. Methadone was less expensive compared to fentanyl and morphine but required clinical expertise in dosing due to the need to decrease and then increase the dose in some patients.
Long-acting morphine, fentanyl, and methadone are effective in controlling pain in advanced cancer. Methadone is an option for patients where cost is a concern, but prescribing methadone requires clinical expertise.