Clinical trial NCT05663723: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nervous System Diseases AND Breast Neoplasms
Keywords: Breast cancer
Peripheral neuropathy
Chemotherapy
Photobiomodulation
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: COSMEDICAL
First posted: 2022-12-23
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral neuropathy
timeFrame: Until the conclusion of the study, on average 14 months
Secondary outcomes:
measure: Lower limb pain
timeFrame: Until the conclusion of the study, on average 14 months
measure: Overall Muscle Strength
timeFrame: Until the conclusion of the study, on average 14 months
measure: Body Balance
timeFrame: Until the conclusion of the study, on average 14 months
measure: Lower limb sensitivity
timeFrame: until the conclusion of the study, on average 14 months
measure: Health-related quality of life
timeFrame: Until the conclusion of the study, on average 14 months
measure: Satisfaction with the use of photobiomodulation
timeFrame: Until the conclusion of the study, on average 14 months
measure: Assessment of Adherence to Treatment
timeFrame: Until the conclusion of the study, on average 14 months
measure: Impact of Peripheral Neuropathy on Activities of Daily Living
timeFrame: Until the conclusion of the study, on average 14 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Erica Alves Nogueira Fabro
Study officials:
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