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NCT Number: NCT05663723

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).

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Key information

Conditions

Peripheral Nervous System Diseases AND Breast Neoplasms Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erica Alves Nogueira Fabro

Rio de Janeiro, 20530-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group with the IV and V LED board

Device

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 board

Device

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 light

Device

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.

Primary outcomes

  1. Peripheral neuropathy

    Time frame: 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 outcomes

  1. Lower limb pain

    Time frame: Until the conclusion of the study, on average 14 months

    Short Form McGill Questionnaire, which is the McGill questionnaire in its shortened form

  2. Overall Muscle Strength

    Time frame: Until the conclusion of the study, on average 14 months

    Hydraulic Jamar Dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440)

  3. Body Balance

    Time frame: Until the conclusion of the study, on average 14 months

    Timed Up and Go Test (TUG)

  4. Lower limb sensitivity

    Time frame: until the conclusion of the study, on average 14 months

    Esthesiometer (monofilaments)

  5. Health-related quality of life

    Time frame: 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)

  6. Satisfaction with the use of photobiomodulation

    Time frame: Until the conclusion of the study, on average 14 months

    Questions will be asked about overall satisfaction with the management of peripheral neuropathy

  7. Assessment of Adherence to Treatment

    Time frame: 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.

  8. Impact of Peripheral Neuropathy on Activities of Daily Living

    Time frame: Until the conclusion of the study, on average 14 months

    Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ)

Sponsors and collaborators

Lead sponsor

Erica Alves Nogueira Fabro

Other Gov

Collaborators

  • BLED MED COMERCIO E DISTRIBUIÇÃO LTDA
  • COSMEDICAL

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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