Peripheral Nervous System Diseases AND Breast Neoplasms Clinical Trial
Official title:
Photobiomodulation for Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
Double-blind Superiority Randomized Controlled Clinical Trial. Objective of the study: To evaluate the effectiveness of photobiomodulation using the LED board in the prevention of peripheral neuropathy in the lower limbs in women with breast cancer undergoing chemotherapy at the Cancer Hospital III of the National Cancer Institute (HCIII/INCA).
Materials and methods: This is a single-blind superiority randomized controlled clinical trial. Women aged over 18 years, with breast cancer in stages I to IIIC and who have an indication for curative treatment with neoadjuvant or adjuvant chemotherapy at HCIII/INCA will be eligible. Patients with a previous diagnosis of another primary cancer will be excluded; patients undergoing surgery and/or chemotherapy at another institution; patients who previously had altered sensitivity in the feet; patients who are unable to answer the questionnaires and patients unable to receive photobiomodulation due to acute infections in the lower limbs. After recruitment, the women will be allocated into three groups: two Intervention groups (use of the IV and V LED board; and IV, V and Violet) and a Control group (use of the LED board without light emission). Peripheral neuropathy, pain, global muscle strength, body balance, sensitivity, health-related quality of life and related independent variables will be evaluated, such as the characteristics of the patient, the tumor and the oncological treatment performed. Data analysis: Statistical analysis will be conducted following intention-to-treat principles. Data normality will be tested using the Kolmogorov Smirnov test, considering as normal distribution those with p > 0.05. ;