Abstract | BACKGROUND: METHODS/DESIGN: This is a two-arm, randomized controlled trial. A total of 52 patients undergoing radiotherapy for breast cancer (stages I to III) will be enrolled. Patients will be randomly assigned to an intervention group to receive laser therapy (n = 26) or a control group to receive a placebo (n = 26). The laser or placebo will be applied five days a week, immediately before each radiotherapy session. Skin reactions will then be graded weekly by a nurse, a radiotherapist, and an oncologist (all of whom will be blinded) using the Common Toxicity Criteria (CTC) developed by the National Cancer Institute and the Acute Radiation Morbidity Scoring Criteria developed by the Radiation Therapy Oncology Group. Patients will also answer a modified visual analogue scale for pain (a self-evaluation questionnaire). Primary and secondary outcomes will be the prevention of radiodermatitis and pain secondary to radiodermatitis, respectively. DISCUSSION: The ideal tool for preventing radiodermatitis is an agent that mediates DNA repair or promotes cell proliferation. Application of a low-power laser has been shown to promote tissue repair by reducing inflammation and inducing collagen synthesis. Moreover, this treatment approach has not been associated with adverse events and is cost-effective. Thus, the results of this ongoing trial may establish whether use of a low-power laser represents an ideal treatment option for the prevention of radiodermatitis. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02003599. Registered on 2 December 2013.
|
Authors | Marina Moreira Costa, Sidney Benedito Silva, Ana Luiza Pereira Quinto, Priscilla Furtado Souza Pasquinelli, Vanessa de Queiroz dos Santos, Gabriela de Cássia Santos, Daniela Francescato Veiga |
Journal | Trials
(Trials)
Vol. 15
Pg. 330
(Aug 20 2014)
ISSN: 1745-6215 [Electronic] England |
PMID | 25141962
(Publication Type: Journal Article, Randomized Controlled Trial)
|
Topics |
- Breast Neoplasms
(radiotherapy)
- Clinical Protocols
- Female
- Humans
- Low-Level Light Therapy
(adverse effects)
- Phototherapy
(adverse effects)
- Radiodermatitis
(prevention & control)
- Radiotherapy, Adjuvant
(adverse effects)
|