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

Primary Purpose

Peripheral Nervous System Diseases AND Breast Neoplasms

Status

Not yet recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Intervention group with the IV and V LED board

Intervention group with the IV, V and Violet LED board

Control group with LED board without emitting light

About this trial

This is an interventional prevention trial for Peripheral Nervous System Diseases AND Breast Neoplasms focused on measuring Breast cancer, Peripheral neuropathy, Chemotherapy, Photobiomodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Erica Alves Nogueira Fabro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group with the IV and V LED board

Intervention group with the IV, V and Violet LED board

Control group with LED board without emitting light

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Peripheral neuropathy

Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ), which is validated and translated from the Chemotherapy Induced Peripheral Neuropathy Assessment Tool - (CIPNAT).

Secondary Outcome Measures

Lower limb pain

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

Overall Muscle Strength

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

Body Balance

Timed Up and Go Test (TUG)

Lower limb sensitivity

Esthesiometer (monofilaments)

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)

Satisfaction with the use of photobiomodulation

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

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.

Impact of Peripheral Neuropathy on Activities of Daily Living

Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ)

Full Information

NCT ID

NCT05663723

First Posted

November 30, 2022

Last Updated

December 15, 2022

Sponsor

Erica Alves Nogueira Fabro

Collaborators

COSMEDICAL

1. Study Identification

Unique Protocol Identification Number

NCT05663723

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 10, 2023 (Anticipated)

Primary Completion Date

December 29, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Erica Alves Nogueira Fabro

Collaborators

COSMEDICAL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Nervous System Diseases AND Breast Neoplasms

Keywords

Breast cancer, Peripheral neuropathy, Chemotherapy, Photobiomodulation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

Only outcome assessors and patients will be blinded to group allocation.

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group with the IV and V LED board

Arm Type

Active Comparator

Arm Description

Arm Title

Intervention group with the IV, V and Violet LED board

Arm Type

Active Comparator

Arm Description

Arm Title

Control group with LED board without emitting light

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Intervention group with the IV and V LED board

Intervention Description

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 Type

Device

Intervention Name(s)

Intervention group with the IV, V and Violet LED board

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Control group with LED board without emitting light

Intervention Description

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 Outcome Measure Information:

Title

Peripheral neuropathy

Description

Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ), which is validated and translated from the Chemotherapy Induced Peripheral Neuropathy Assessment Tool - (CIPNAT).

Time Frame

Until the conclusion of the study, on average 14 months

Secondary Outcome Measure Information:

Title

Lower limb pain

Description

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

Time Frame

Until the conclusion of the study, on average 14 months

Title

Overall Muscle Strength

Description

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

Time Frame

Until the conclusion of the study, on average 14 months

Title

Body Balance

Description

Timed Up and Go Test (TUG)

Time Frame

Until the conclusion of the study, on average 14 months

Title

Lower limb sensitivity

Description

Esthesiometer (monofilaments)

Time Frame

until the conclusion of the study, on average 14 months

Title

Health-related quality of life

Description

Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group - Neurotoxicity Questionnaire (FACT/GOG-NTX), Portuguese version FACT/GOG-NTX (Portuguese version)

Time Frame

Until the conclusion of the study, on average 14 months

Title

Satisfaction with the use of photobiomodulation

Description

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

Time Frame

Until the conclusion of the study, on average 14 months

Title

Assessment of Adherence to Treatment

Description

Time Frame

Until the conclusion of the study, on average 14 months

Title

Impact of Peripheral Neuropathy on Activities of Daily Living

Description

Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ)

Time Frame

Until the conclusion of the study, on average 14 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women diagnosed with breast cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Erica Alves Nogueira Fabro

City

Rio de Janeiro

ZIP/Postal Code

20530-003

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

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

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