Photobiomodulation for Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer

Not Applicable

Completed

• Conditions: Peripheral Nervous System Diseases AND Breast Neoplasms

• Registration Number: NCT05663723
• Lead Sponsor: Erica Alves Nogueira Fabro

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-23
• Study Start: 2023-03-08
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-21
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

Inclusion Criteria

• 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 in HCIII/INCA.

Exclusion Criteria

• Patients with a previous diagnosis of another primary cancer
• Patients undergoing surgery and/or chemotherapy at another Institution
• Patients who previously had altered sensitivity in the feet
• Patients who are unable to respond to questionnaires
• Patients unable to receive photobiomodulation due to acute lower limb infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peripheral neuropathy	Until the conclusion of the study, on average 14 months	Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ), which is validated and translated from the Chemotherapy Induced Peripheral Neuropathy Assessment Tool - (CIPNAT).

Secondary Outcome Measures

Name	Time	Method
Lower limb sensitivity	until the conclusion of the study, on average 14 months	Esthesiometer (monofilaments)
Satisfaction with the use of photobiomodulation	Until the conclusion of the study, on average 14 months	Questions will be asked about overall satisfaction with the management of peripheral neuropathy
Overall Muscle Strength	Until the conclusion of the study, on average 14 months	Hydraulic Jamar Dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440)
Lower limb pain	Until the conclusion of the study, on average 14 months	Short Form McGill Questionnaire, which is the McGill questionnaire in its shortened form
Body Balance	Until the conclusion of the study, on average 14 months	Timed Up and Go Test (TUG)
Health-related quality of life	Until the conclusion of the study, on average 14 months	Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group - Neurotoxicity Questionnaire (FACT/GOG-NTX), Portuguese version FACT/GOG-NTX (Portuguese version)
Assessment of Adherence to Treatment	Until the conclusion of the study, on average 14 months	The LED board application diary will be used in which patients in intervention group A and B and control will be instructed to fill it in daily during the intervention period. In this diary, patients must inform the date of application of the LED board, if it was performed on both feet and if the duration time was 20 minutes on each limb. The LED board application diary must be delivered by the patient or family member to a physiotherapist who will be responsible for receiving it, on the last day of the chemotherapy treatment.
Impact of Peripheral Neuropathy on Activities of Daily Living	Until the conclusion of the study, on average 14 months	Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ)

Trial Locations

Locations (1)

Erica Alves Nogueira Fabro; 🇧🇷 Rio de Janeiro, Brazil