Gottschling, S., Reindl, T.K., Meyer, S., Berrang, J., Henze, G., Graeber, S., … Graf, N. (2008). Acupuncture to alleviate chemotherapy-induced nausea and vomiting in pediatric oncology—A randomized multicenter crossover pilot trial. Klinische Padiatrie, 220, 365–370.
To evaluate the efficacy and acceptance of acupuncture as an additive antiemetic treatment during highly emetogenic chemotherapy (HEC) in pediatric patients with cancer
Patients receiving chemotherapy were randomized to receive antiemetic medication plus acupuncture or antiemetic medication alone.
Acupuncture points were based on the acupuncturists’ decision, until the patient reported a “de Qi” sensation.
Antiemetic rescue medication, number of retching and vomiting episodes, and a short essay of the acupuncture experience were recorded.
This study was conducted in multiple inpatient settings in five German cancer centers.
This was a prospective, randomized, crossover clinical trial pilot study.
An open-form essay was used to document the subjective experience of acupuncture.
In evaluating chemotherapy courses, overall, no significant differences were found in retching or vomiting episodes. In evaluating differences between group 1 and group 2, no significant effect was found with dexamethasone (p = 0.145); however, the acupuncture group was associated with lower phenothiazine medication use (p = 0.001) and less retching and vomiting episodes (p = 0.01).
Acupuncture with baseline antiemetic medication was associated with less phenothiazine use and less retching and vomiting among children receiving HEC.
Acupuncture may provide some relief of retching or vomiting episodes associated with HEC, but the intervention should be used in combination with standard antiemetic treatment.
Gothard, L., Haviland, J., Bryson, P., Laden, G., Glover, M., Harrison, S., . . . Yarnold, J. (2010). Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer. Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology, 97(1), 101–107.
To assess the effectiveness of hyperbaric oxygen (HBO) therapy on reducing arm lymphedema in patients with early-stage breast cancer
Participants were divided into the control and the experimental group at a ratio of 1 to 2, respectively. The experimental group received HBO therapy and breathed 100% oxygen at 2.4 atmospheres absolute for 100 minutes with two five-minute air breaks. The sessions were conducted 30 times in a six-week period or five times a week. Both the control and experimental groups received patient education on standard care for lymphedema and hosiery when appropriate.
The study took place in multiple hospitals in the United Kingdom.
Patients were undergoing active lymphedema treatment.
The study used a randomized phase II study design.
There was not a statistically significant change in limb volume between the control group (p = 0.64) and the experimental group (p = 0.50) at 12 months after baseline. The investigators define a positive response as an 8% reduction in arm volume. Thirty percent of the experimental group versus 18.8% of the control group responded to meet these criteria but was also statistically insignificant (p = 0.50). Lymphatic clearance rates were similar among groups and were not significant findings. Quality of life findings were similar among both groups and were not significant.
The study suggests that HBO therapy when added to best standard treatment of lymphedema in patients with breast cancer is not effective. The study does not confirm earlier reports of a therapeutic effect of HBO.
The study suggests that HBO therapy is an ineffective therapy for treating lymphedema in patients with breast cancer. The therapy should not be enacted into practice. Nursing researchers should analyze the randomized trial and non-randomized trials of this treatment program to identify confounding variables that may have made the non-randomized trial results significant and the randomized trial results not significant. If the study is repeated a larger sample size should be used.
Gothard, L., Stanton, A., MacLaren, J., Lawrence, D., Hall, E., Mortimer, P., . . . Yarnold, J. (2004). Non-randomized phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphedema and tissue fibrosis after radiotherapy for early breast cancer. Radiotherapy and Oncology, 70(3), 217–224.
To examine hyperbaric oxygen in the treatment of chronic arm lymphedema after radiotherapy
Patients received treatment with hyperbaric oxygen, compressed to 2.4 atmospheres absolute (ATA) in a multiplace category 1 hyperbaric chamber at Royal Hospital. Patients received 100% oxygen at pressure via a transparent hood. Total time at 2.4 ATA was 100 minutes, including two five-minute air breaks. Each participant received a total of 30 pressure exposures, treating five days per week for six weeks. The primary endpoint was an absolute change of greater than 20% in relative volume of the ipsilateral arm versus contralateral arm. The secondary endpoints were lymphoscintigraphy, patient self-assessments, and physician assessments. An unplanned endpoint was patient comments about arm softening and mobility as part of one relative change in arm volume.
The study took place at Royal Marsden Hospital based on observation from a previous study at the same institution evaluating hyperbaric oxygen in radiation-induced brachial plexopathy. In that study, two of the six patients with chronic lymphedema experienced major and persistent improvement in lymphedema.
Compliance with treatment was 100%. All questionnaires were returned, and only two patients missed follow-up assessments (one patient was hospitalized and the other moved); as a result, 94% of patients had Perometer measures. Only 71% participated in lymphoscintigraphy because of logistics, 7% missed follow-up scan at 12 months, and one scan was erased accidentally. Three patients responded according to defined 20% or greater reduction in arm volume, 16 were nonresponders. Mean percentage reduction in arm volume was 7.68. Quality-of-life measures were not clinically significant post-treatment. Comments by participants indicated they may not have been appropriate measures. Lymphoscinitgraphy improvement showed statistically significant changes.
Patients had good compliance with the treatment plan despite rigorous treatment. Median time since completion of the treatment is 14 years, which is encouraging given improvement in lymphoscintigraphy measures and limb tissue softening (a subjective measure).
The study has sufficient data to justify a randomized controlled trial. Careful screening of participants is needed.
Gotay, C.C., Moinpour, C.M., Unger, J.M., Jiang, C.S., Coleman, D., Martino, S. . . . Albain, K.S. (2007). Impact of a peer-delivered telephone intervention for women experiencing a breast cancer recurrence. Journal of Clinical Oncology, 25 (15), 2093–2098.
To evaluate the effects a brief telephone intervention on women experiencing a recurrence of breast cancer
Women were randomly assigned to either a telephone-intervention group (TG) or a control group (CG). TG received 4–8 counseling/information sessions by telephone at weekly intervals. Session content reflected primary patient concerns and common domains from a quality-of-life (QOL) model. After the first session, patients received an information packet. The packet consisted primarily of National Cancer Institute pamphlets. Counselors were breast cancer recurrence survivors at least one year postrecurrence. Assessments were completed at baseline, three months, and six months.
The study was conducted by SWOG (formerly the Southwest Oncology Group)—an organization, supported by the National Cancer Institute, that conducts clinical trials relating to cancer in adults.
Multisite
Secondary-outcome assessments:
Support services utilized and satisfaction with the telephone intervention were requested.
The telephone intervention was feasible and well accepted, but authors noted no benefits associated with the intervention, in regard to either emotional well-being or depressive symptoms. Patient distress started and remained very high in this sample. Statistically significant was the fact that more CG patients progressed during the six months of the study than did members of the TG group.
This is a well-designed RCT with adequate sample size; however, the study’s generalizability is unclear, given that the patients came from multiple institutions across the United States. The catchment cannot be precisely described, and characteristics of refusing patients were not reported. This sample included high levels of psychological and disease-related disability, and telephone calls from a nonprofessional may not have been an appropriate means of modifying patient distress. The study presents no significant findings.
Gosselin, T.K., Schneider, S.M., Plambeck, M.A., & Rowe, K. (2010). A prospective randomized, placebo-controlled skin care study in women diagnosed with breast cancer undergoing radiation therapy. Oncology Nursing Forum, 37(5), 619–626.
To compare the effectiveness of three different products in reducing incidence of radiodermatitis
Women were randomly assigned to placebo (sterile water mist), Aquaphor, Biafine or RadiaCare gel. Patients were instructed to apply the product two times daily with the start of radiotherapy and until treatment was complete. Patients were not to use any other skin care product on the affected area. The radiation nurse assessed patients weekly and reminded them to complete home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of observations.
The study took place in an outpatient setting at Duke University.
Patients were undergoing active antitumor treatment.
The study used a double-blind placebo-controlled randomized four-group trial design.
Ninety-five percent of patients had a skin reaction, with most occurring by week 4. None of the products tested showed a significant difference to reduce the incidence of grade 2–4 skin toxicity compared to placebo. Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reaction were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study. Biafine was associated with the greatest increase in toxicity across groups.
None of the products tested here were better than placebo in reducing incidence of grade 2–4 radiodermatitis.
Findings suggest that none of these particular products are effective, although a systematic review and meta-analysis in this area suggest that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.
Gosselin, T. K., Schneider, S. M., Plambeck, M. A., & Rowe, K. (2010). A prospective randomized, placebo-controlled skin care study in women diagnosed with breast cancer undergoing radiation therapy. Oncology Nursing Forum, 37, 619–626.
To compare the effectiveness of three products in reducing the incidence of radiodermatitis.
Women were randomly assigned to placebo (sterile water mist), Aquaphor, Biafine, or radiacare gel. Patients were instructed to apply the product two times daily with the start of radiation therapy (RT) and until treatment was complete. Patients were not to use any other skin care product on the affected area. The radiation nurse assessed patients weekly and reminded them to complete their home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of the observations.
Patients were undergoing the active antitumor treatment phase of care.
The study was a double-blind, placebo-controlled, randomized, four-group trial.
Of the patients, 95% had a skin reaction, with most occurring by week 4. No product tested showed a significant difference in reducing the incidence of grade 2 to 4 skin toxicity compared to placebo. Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reactions were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study.
No product tested was better than placebo in reducing the incidence of grade 2 to 4 radiodermatitis.
Biafine, Aquaphor, and radiacare gel were no more effective than placebo in reducing the incidence of clinically relevant skin toxicity with RT in patients with breast cancer. Biafine was associated with the greatest increase in toxicity across groups. Findings suggested that none of these products are effective, although a systematic review and meta-analysis in this area suggests that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.
Sheinfeld Gorin, S., Krebs, P., Badr, H., Janke, E.A., Jim, H.S., Spring, B., . . . Jacobsen, P.B. (2012). Meta-analysis of psychosocial interventions to reduce pain in patients with cancer. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 30(5), 539–547.
The search retrieved 1,681 studies published 1996–2010. Three pairs of raters independently reviewed 1,681 abstracts, using an online coding program designed for this project. Studies meeting the inclusion criteria were evaluated for quality according to a modified seven-item coding scheme based on the Physiotherapy Evidence Database. The project leader reviewed findings from rater pairs, resolved discrepancies, and produced a final list of studies for full-text examination. The list of studies was divided among the three pairs of raters.
The weighted average effect size in 38 comparisons for pain severity (k = 38) was 0.34 (95% CI 0.23–0.46; p < 0.001). The weighted average effect size in four comparisons for pain interference was 0.40 (95% CI 0.21–0.60; p < 0.001). Among studies that measured pain severity, skills-based interventions yielded a higher but statistically nonsignificant effect size than did educational approaches (k = 18, g = 0.45 versus k = 19, g = –0.29, respectively; p = 0.22).
Psychosocial interventions decrease cancer-related pain severity and the extent to which pain interferes with activities. Both skills instruction and education approaches can improve the management of cancer pain.
Gore, L., Chawla, S., Petrilli, A., Hemenway, M., Schissel, D., Chua, V., … Adolescent Aprepitant in Cancer Study Group. (2009). Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: A randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatric Blood and Cancer, 52, 242–247.
To evaluate the tolerability, efficacy, and pharmacokinetics of aprepitant with a 5-HT3 receptor antagonist and corticosteroid in adolescents with cancer
Patients were randomized to receive either a regimen of aprepitant plus dexamethasone and ondansetron or the control arm of ondansetron and dexamethasone. On the day of chemotherapy, aprepitant or placebo was administered 1 hour before and dexamethasone and ondansetron were given 30 minutes before chemotherapy. Rescue medication was permitted. Patient follow-up was done between days 6 and 8 and between days 19 and 29. Patients recorded episodes of vomiting in diaries for five days following chemotherapy. For the experimental arm, aprepitant was given at 125 mg day 1, 80 mg days 2 and 3, 4 mg day 4; 8 mg dexamethasone day 1, 4 mg days 2 and 3; and ondansetron at 0.15 mg/kg, three times per day on days 1 and 2. In the control arm, patients received 16 mg dexamethasone on day 1, 8 mg on days 2–4, and ondansetron at 0.15 mg/kg, three times per day on days 1 and 2.
The study was conducted at a single outpatient setting at Children’s Hospital, University of Colorado.
The patients were pediatric, in active treatment.
This was a randomized, double-blind, parallel group study.
More patients in the aprepitant group achieved CR for CINV control in the acute and delayed phases, as well as in the overall study period. The addition of aprepitant to the antiemetic regimen appeared to be well tolerated in adolescents, with an overall adverse event profile similar to that seen in adults.
Findings suggest that aprepitant in addition to standard antiemetic treatment is tolerable and may be helpful in patients between the ages of 11 and 19. Further study of the efficacy of antiemetic regimens in the pediatric and adolescent populations is warranted.
Gordon, J.N., Trebble, T.M., Ellis, R.D., Duncan, H.D., Johns, T., & Goggin, P.M. (2005). Thalidomide in the treatment of cancer cachexia: A randomised placebo controlled trial. Gut, 54, 540–545.
To evaluate the safety and efficacy of thalidomide in attenuating weight loss in patients with cachexia secondary to advanced pancreatic cancer
Fifty patients were randomized to receive 200 mg of thalidomide by mouth daily or placebo for 24 weeks. At four weeks, 33 patients were evaluated; at eight weeks, 20 patients were evaluated.
Patients were included in the study if they
Patients were excluded if they
The study was a randomized, placebo-controlled trial.
At four weeks, 33 patients were evaluable. The thalidomide arm gained 0.37 kg in weight and 1 cm3 of arm circumference muscle mass. The placebo arm lost 2.21 kg in weight and 4.46 cm3 of arm circumference muscle mass.
At eight weeks, 20 patients were evaluable. The thalidomide arm lost 0.06 kg in weight and 0.5 cm3 of arm circumference muscle mass. The placebo arm lost 3.62 kg in weight and 8.4 cm3 of arm circumference muscle mass.
Thalidomide was well tolerated and effective at attenuating weight loss and loss of lean body mass. Findings were unable to demonstrate that attenuation in weight loss led to improvement in quality of life.
Good, P., Jackson, K., Brumley, D., & Ashby, M. (2009). Intranasal sufentanil for cancer-associated breakthrough pain. Palliative Medicine, 23(1), 54–58.
To demonstrate the efficacy, safety, and acceptability of intranasal sufentanil as a treatment for cancer-related breakthrough pain (BTP)
Dose titration included three steps. In step 1, a clinician administered 9 mcg sufentanil. Administration was repeated at 10 and 20 minutes, as required. If sufentanil was ineffective at 30 minutes, the clinician administered, the patient's usual BTP opioid. Step 2 comprised actions relating to the next episode of BTP. During this episode, the clinician administered 18 mcg sufentanil, using the same repetition procedure as in step 1. In step 3, during the next episode of BTP, the clinician administered 36 mcg sufentanil, using the same repetition procedure as in step 1. In all steps, pain was assessed at 0, 5, 10, 15, 30, 60, and 120 minutes. In the ongoing phase of the study, in each BTP episode, each patient received the titrated dose that had proven effective.
Prospective, descriptive study
The study showed that intranasal sufentanil has rapid onset and is an effective and safe means of controlling cancer-related BTP.
Sufentanil may be an option for the treatment of BTP; presently, however, its use remains investigational.