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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Nervous System Diseases AND Breast Neoplasms

Intervention / Treatment
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* Device: Intervention group with the IV and V LED board
* Device: Intervention group with the IV, V and Violet LED board
* Device: Control group with LED board without emitting light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention and control groups will be: Group A: Intervention group with the IV and V LED board. Group B: Intervention group with the IV, V and Violet LED board. Group C: Control group with the LED board without emitting light.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group with the IV and V LED board<br>Time of Applications will 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. | Device: Intervention group with the IV and V LED board<br>* 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.<br>|
| Active Comparator: Intervention group with the IV, V and Violet LED board<br>Time of Applications will be 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. | Device: Intervention group with the IV, V and Violet LED board<br>* 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.<br>|
| Placebo Comparator: Control group with LED board without emitting light<br>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. Women will receive a booklet with guidelines for the correct use of the LED board and will be instructed to continue their usual physical activities and mark the daily frequency of application of the LED board | Device: Control group with LED board without emitting light<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb pain | Short Form McGill Questionnaire, which is the McGill questionnaire in its shortened form | Until the conclusion of the study, on average 14 months | 
| Overall Muscle Strength | Hydraulic Jamar Dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440) | Until the conclusion of the study, on average 14 months | 
| Body Balance | Timed Up and Go Test (TUG) | Until the conclusion of the study, on average 14 months | 
| Lower limb sensitivity | Esthesiometer (monofilaments) | until the conclusion of the study, on average 14 months | 
| Health-related quality of life | Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group - Neurotoxicity Questionnaire (FACT/GOG-NTX), Portuguese version FACT/GOG-NTX (Portuguese version) | Until the conclusion of the study, on average 14 months | 
| Satisfaction with the use of photobiomodulation | Questions will be asked about overall satisfaction with the management of peripheral neuropathy | Until the conclusion of the study, on average 14 months | 
| Assessment of Adherence to Treatment | 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. | Until the conclusion of the study, on average 14 months | 
| Impact of Peripheral Neuropathy on Activities of Daily Living | Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ) | Until the conclusion of the study, on average 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Peripheral neuropathy, Chemotherapy, Photobiomodulation