Younus, J., Lock, M., Vujovic, O., Yu, E., Malec, J., D'Souza, D., & Stitt, L. (2015). A case-control, mono-center, open-label, pilot study to evaluate the feasibility of therapeutic touch in preventing radiation dermatitis in women with breast cancer receiving adjuvant radiation therapy. Complementary Therapies in Medicine, 23, 612–616.
DOI Link
Study Purpose
To evaluate the feasibility of therapeutic touch (TT) in preventing radiation-induced dermatitis in patients with breast cancer who are receiving radiation treatment
Intervention Characteristics/Basic Study Process
Women with stage I and II breast cancer who had received conservative surgery and were receiving adjuvant radiation therapy were recruited for the study. TT treatment was administered three times a week following radiation therapy. Feasibility was defined as a threshold of 15 of 17 patients completing all TT treatment. The preventive effectiveness evaluation was conducted by documenting the “time to develop” and “worst grade of radiodermatitis.” Patients were followed weekly while on treatment and for one week post-treatment.
Sample Characteristics
- N = 49
- AGE = 18–80 years
- FEMALES: 100%
- CURRENT TREATMENT: Radiation
- KEY DISEASE CHARACTERISTICS: Breast cancer
- OTHER KEY SAMPLE CHARACTERISTICS: Patient who had completed lumpectomy, sentinel lymph node biopsy, or axillary lymph node dissection
Setting
- SITE: Single site
- SETTING TYPE: Outpatient
- LOCATION: London Regional Cancer Program, London
Phase of Care and Clinical Applications
PHASE OF CARE: Active antitumor treatment
Study Design
Prospective case cohort study with two arms: The control arm received the TT treatment and the experimental arm received no treatment.
Measurement Instruments/Methods
- Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
- European Organization for Research and Treatment of Cancer (EORTC) cosmetic rating system
- EORTC Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
- Profile of Mood Status (POMS)
- Brief Fatigue Inventory (BFI)
Results
Forty-nine patients participated in the study (17 in the TT and 32 in the control). A comparison of the two groups for the worst grade of radiodermatitis showed no difference (p = 0.661). The control group median time to develop the worst toxicity was 31 days (95% confidence interval [CI] [23, 35], standard error = 1.3767); in the TT group, it took 22 days to develop the worst toxicity (95% CI [18, 24], standard error = 1.769, p < 0.001). In the control cohort, the worst grade of radiation dermatitis was grade 3 noted in one patient; in the TT cohort, the worst grade was grade 2 noted in nine patients (53%). The most common toxicity grade in 15 patients was grade 2, and three patients did not develop toxicity. There was no difference between the cohort for overall EORTC cosmetic score and no significant difference before or after the study in quality of life, mood, or fatigue scores.
Conclusions
This study was the first evaluation of TT in patients with breast cancer using objective measures and, although it was feasible for the management of radiation induced dermatitis, it was not able to detect any significant benefit on the CTCAE toxicity grade. It also did not show any improvement in outcomes for fatigue, quality of life, or mood.
Limitations
- Small sample (< 100)
- Risk of bias (no blinding)
- Risk of bias (no appropriate attentional control condition)
- Key sample group differences that could influence results
- Feasibility for radiation-induced dermatitis management but not for prevention