CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
Intervention group with the IV and V LED board +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05663723
NCT05663723N/ACompleted

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

Erica Alves Nogueira Fabro·interventional·Posted Dec 23, 2022·Updated Jun 26, 2025

In Brief

A clinical study evaluating Intervention group with the IV and V LED board, Intervention group with the IV, V and Violet LED board, and 1 other intervention for Peripheral Nervous System Diseases AND Breast Neoplasms. Completed, enrolled 186 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
2023202420252026
First PostedDec 23, 2022
Enrollment StartMar 8, 2023
Primary CompletionJun 4, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.5 years ago

Interventions

Intervention group with the IV and V LED boarddevice

Applications of the LED board will be performed daily for 20 minutes on each extremity (foot soles), until the last day of chemotherapy treatment. The sequential LED treatments will be administered by the Sportllux Ultra model (Cosmedical) in a predefined cycle, with the combination of light emitters in two wavelengths: 42 red (660nm) and 42 infrared (850nm); LED blanket in the size of 10x12 cm; average power of each LED: 5mW; operating mode: continuous; polarization: random; irradiance at the opening of each LED: 25mW/cm2; opening diameter of each LED: 10mm; application time: 1 session of 20 minutes; power per LED: 30mW; radiant exposure: 36J/cm2 during 20 minutes of application. Tissue from the lower limb extremities will come into contact with the LED panel during treatment to ensure even delivery of photobiomodulation. The panels are large enough to more than cover the entire edge area at one time during application.

Intervention group with the IV, V and Violet LED boarddevice

Applications of the LED board will be performed daily for 20 minutes on each extremity (foot soles), until the last day of chemotherapy treatment. The sequential LED treatments will be administered by the Sportllux Ultra model (Cosmedical) in a predefined cycle, with the combination of light emitters in three wavelengths: 18 red (660nm), 18 infrared (850nm) and 36 violet (420nm). ); LED blanket in the size of 10x12 cm; average power of each LED: 5mW; operating mode: continuous; polarization: random; irradiance at the opening of each LED: 25mW/cm2; opening diameter of each LED: 10mm; application time: 1 session of 20 minutes; power per LED: 30mW; radiant exposure: 36J/cm2 during 20 minutes of application. Tissue from the lower limb extremities will come into contact with the LED panel during treatment to ensure even delivery of photobiomodulation. The panels are large enough to more than cover the entire edge area at one time during application.

Control group with LED board without emitting lightdevice

Applications of the LED board will be performed daily for 20 minutes on each extremity (foot soles), until the last day of chemotherapy treatment. The sequential LED treatments will be administered by the Sportllux Ultra (Cosmedical) model without the light emitting combination. LED blanket in the size of 10x12 cm and application time: 1 session of 20 minutes. Tissue from the lower limb extremities will come into contact with the LED panel during treatment to ensure even delivery of photobiomodulation. The panels are large enough to more than cover the entire edge area at one time during application.