Milano-Bausset, E., Gaudart, J., Rome, A., Coze, C., Gentet, J.C., Padovani, L., . . . André, N. (2009). Retrospective comparison of neutropenia in children witih Ewing sarcoma treated with chemotherapy and granulocyte colony-stimulating factor (G-CSF) or pegylated G-CSF. Clinical Therapeutics, 31, 2388–2395.
The purpose of the study was to compare efficacy of pegfilgrastim and filgrastim administered after chemotherapy in children with Ewing sarcoma.
All patients received both types of G-CSF in different treatment courses of chemotherapy, which consisted of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE); vincristine, atinomycin D, and ifosfamide (VAI); or vincristine, atcinomycin D, and cyclophosphade (VAC). A single injection of pegfilgrastim 100 mcg/kg subcutaneously or a daily injection of filgrastim 5–10 mcg/kg subcutaneously was administered 48–72 hours after the completion of chemotherapy. Twenty children were included. A total of 178 chemotherapy courses were administered and evaluated, including 134 courses with pegfilgrastim and 44 courses with filgrastim.
Single-site location in Marseille, France
Retrospective chart review
Considering all types of chemotherapy combined, those courses in which pegfilgrastim was used were associated with a significantly lower incidence versus severe neutropenia (0.21 versus 0.85; p = 0.034), a shorter duration of severe neutropenia (0.49 versus 2.36 days; p = 0.01), and a shorter duration of antibiotic treatment (1.07 versus 4.22 days; p = 0.03) compared with courses with filgrastim. No statistically significant differences were observed for the proportion of febrile neutropenia, duration of hospitalization, or transfusions.
Using pegfilgrastim after chemotherapy courses was associated with significantly reduced frequency and shorter duration of severe neutropenia compared with those courses followed by filgrastim.
Randomized, controlled trials are needed to confirm the results.
Miladinia, M., Baraz, S., Shariati, A., & Malehi, A.S. (2016). Effects of slow-stroke back massage on symptom cluster in adult patients with acute leukemia: Supportive care in cancer nursing. Cancer Nursing. Advance online publication.
To examine the effects of slow-stroke back massage on the symptom cluster of fatigue, pain, and sleep disturbance
Patients were assigned to massage or usual care control groups according to a fixed approach such that the first three patients entered into the study were assigned to the intervention, the next three to control, and so on. Massage was provided by two oncology nurses who had four months of professional training. The intervention group received 10-minute massage sessions every other day for four weeks in a special room in an outpatient setting. Control patients were given social attention. Data collectors were blinded to the study assignment. Soothing music was provided during the massages.
Repeated measures ANOVA showed a significant difference in pain, fatigue (p = 0.001), and sleep disorder intensity (p = 0.015) from baseline to the end of week 5. By the end of week 4, PSQI scores showed improvement in the intervention group compared to controls (p = 0.003). Trends showed a consistent decline in pain, fatigue, and sleep disturbance intensity during the four weeks in which massage was done in the intervention group, while in the control group, intensity of these symptoms increased.
Sessions of slow-stroke back massage were shown to reduce intensity of pain, fatigue, and sleep disturbance.
Massage was shown to be of benefit in dealing with the symptoms of pain, fatigue, and sleep disturbance during the treatment phase for patients with leukemia. Nurses can apply massage as a low-risk intervention. Trend results in this study suggest that massage likely has only short-term effects as symptom intensity levels began to rise after the four-week intervention. Ongoing research is needed to evaluate the optimum frequency and timing of massage and duration of effects.
Miki, E., Kataoka, T., & Okamura, H. (2014). Feasibility and efficacy of speed‐feedback therapy with a bicycle ergometer on cognitive function in elderly cancer patients in Japan. Psycho‐Oncology, 23, 906–913.
To determine the feasibility and effectiveness of speed-feedback therapy on improving cognitive function in elderly patients with cancer
The intervention consisted of subjects pedaling for five minutes on a bicycle ergometer once per week for four weeks compared to usual daily life activities. The bicycle ergometer was linked to a computer with the screen displaying the target speed, revolutions per minute, and a changing path for the subjects to follow. Subject’s actual speed and revolutions were displayed as the subject tried to match the target speed and revolutions on the path on the screen. The exercise load was set at 20 W, and the maximum number of rotations was set at 80 revolutions per minute. Demographic data were collected at baseline. Cognitive function and other assessments were obtained at baseline and at week 4.
Randomized, controlled trial design; outcomes evaluator blinded to group assignment
There were more subjects who underwent radiation therapy in the intervention than the control group (p = .01). There were significant differences between groups in the FAB change score for time effect (F = 24.39, p < .001, partial ɳ2 = .247), group effect (F = 9.26, p = .003, partial ɳ2 = .109), and interaction (F = 7.88, p = .006, partial ɳ2 = .094). Younger age was an independent factor associated with greater improvement in FAB scores (p = .018, β = -.264). There were no differences between groups for BI, IADL, or FACT-G scores at baseline or over time.
Findings from this study suggest that speed-feedback therapy may improve cognitive function. However, this intervention required a bicycle ergometer associated with a computer and training by professionals in a hospital setting, which may impact accessibility and costs. Additional studies in other cancer diagnoses with longitudinal follow-ups to demonstrate sustained cognitive improvements is warranted.
Speed-feedback therapy with a bicycle ergometer may be a potential intervention to improve cognitive function, particularly sustained attention. Additional research with larger sample sizes and a longer follow-up period is needed to determine the effectiveness and the sustainability of any improvements in cognitive function.
Migliorati, C., Hewson, I., Lalla, R. V., Antunes, H.S., Estilo, C.L., Hodgson, B., … Elad, S. (2013). Systematic review of laser and other light therapy for the management of oral mucositis in cancer patients. Supportive Care in Cancer, 21(1), 333–341.
To review available literature to develop guidelines for the use of laser and other light therapies in patients with cancer
A total of 692 papers initially were identified, and 24 clinical trials were included in the final review.
Guidelines support use of LLLT for the prevention of oral mucositis in patients undergoing HCT and in patients with head and neck cancer receiving radiotherapy. The research in this area involves a variety of laser devices, protocols, and dosage, making it difficult to identify a specific protocol for clinical application. The most effective wavelengths and dosages are not yet clear. Most protocols examined have involved daily and long treatment times. Based on accumulating evidence, LLLT or other forms of light therapy have the potential to become part of routine treatment.
Migliorati, C.A., Oberle-Edwards, L., & Schubert, M. (2006). The role of alternative and natural agents, cryotherapy and/or laser for management of alimentary mucositis. Supportive Care in Cancer, 14, 533–540.
The process began with a MEDLINE search of research articles from 2002–May 2005. Authors also examined abstracts from American Society of Clinical Oncology, American Society of Hematology, and the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology, as well as the bibliographies of the articles from the MEDLINE search. Articles were included if they involved the use of alternative or natural agents, ice, or laser therapy in the prevention and management of alimentary mucositis.
The initial search identified 167 articles. Of these, 14 were selected and reviewed. These involved one preclinical study on alternative/natural therapy, four clinical studies on cryotherapy, two studies on laser therapy, and seven studies on alternative and natural therapy. The studies were randomized, controlled, and determined to have a low bias potential.
The sample characteristics varied across studies.
Major and minor design flaws prevented the recommendation of scientifically based guidelines. Strong evidence exists for the use of cryotherapy in patients receiving high-dose melphalan (140 mg/m2) as part of the conditioning regimen for hematopoietic stem cell transplantation. Cryotherapy is not appropriate for use with agents with a longer half-life such as methotrexate or doxorubicin. Laser therapy seems promising.
To date, clinical studies with laser therapy have been small, protocols are not standardized, laser devices are different, parameters are varied, and assessment tools are not uniform.
The authors recommended further investigation of the agents and noted the lack of standardized assessment instruments.
Midtgaard, J., Stage, M., Møller, T., Andersen, C., Quist, M., Rörth, M., . . . Adamsen, L. (2011). Exercise may reduce depression but not anxiety in self-referred cancer patients undergoing chemotherapy. Post-hoc analysis of data from the 'Body & Cancer' trial. Acta Oncologica, 50, 660–669.
To investigate the effect of a six-week intervention program including exercise, relaxation, massage, and body awareness training on anxiety and depression in patients undergoing chemotherapy
Patients were randomly assigned to the intervention group or a wait list control group. Patients in the intervention participated in group supervised exercise sessions for six weeks. Sessions involved fitness training on stationary bicycles of 10.5 metabolic equivalents (MET) and heavy resistance training. Warm up and cool down exercises and stretching were also done. All patients received usual care. Control group patients were not restrained from increasing physical activity and participating in available supportive care activities. Data on depression and anxiety were obtained at baseline and were repeated at week 6.
Patients were undergoing the active treatment phase of care.
The study design was post-hoc analysis of data from a randomized controlled trial.
Hospital Anxiety and Depression Scale (HADS)
The intervention group depression score declined a mean of 0.7 points, compared to a decline of 0.24 points on average in the control group (p = 0.015). Patients defined by HADS as borderline or definite cases of depression (n = 24, HADS score ≥ 8) had a mean reduction of –2.53 points, while controls declined an average of 0.25 points (p = 0.021). There were no significant changes or differences between groups in anxiety scores either in the whole sample or in the subgroup defined as baseline borderline or moderate anxiety. Adherence to the exercise sessions was 73.1%.
Exercise may be helpful to reduce depression in patients receiving cancer chemotherapy. No effect on anxiety was observed.
Findings suggest that the intervention tested here, including exercise, group support, massage, and body awareness interventions, may be helpful to combat depression, but may not be helpful for anxiety. However, clinically relevant effects were only seen for depression in those patients who had clinically relevant levels of depression scores at baseline. This suggests that such a program may not be useful to prevent depression, but may be helpful in the situation of actual depression. Screening for depression may be useful to identify those individual patients who are most likely to benefit from this type of approach. Further research is needed to test whether combinations of pharmacotherapy, exercise, and psychotherapy are better than separate approaches to manage anxiety and depression.
Midtgaard, J., Rorth, M., Stelter, R., Tveteras, 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(3), 197–208.
To determine the effectiveness of a specific structured exercise intervention on patients undergoing chemotherapy
Patients with cancer who were undergoing chemotherapy volunteered to participate in the six-week structured exercise program. The total time of all weekly sessions was nine hours per week. Fitness training, relaxation, body awareness training, and high- or low-intensity programs were offered, and safety measures were incorporated. Participants were assessed for depression and anxiety at baseline and after the six-week intervention.
Prospective pre/post-test one-group design
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.