Peripheral Nervous System Diseases AND Breast Neoplasms
Conditions
Keywords
Breast cancer, Peripheral neuropathy, Chemotherapy, Photobiomodulation
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.
Interventions
DEVICEIntervention group with the IV and V LED board
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.
DEVICEIntervention group with the IV, V and Violet LED board
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.
DEVICEControl group with LED board without emitting light
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.
Sponsors
COSMEDICAL
BLED MED COMERCIO E DISTRIBUIÇÃO LTDA
Erica Alves Nogueira Fabro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Only outcome assessors and patients will be blinded to group allocation.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral neuropathy | 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
| Measure | Time frame | Description |
|---|---|---|
| Lower limb pain | Until the conclusion of the study, on average 14 months | Short Form McGill Questionnaire, which is the McGill questionnaire in its shortened form |
| Overall Muscle Strength | Until the conclusion of the study, on average 14 months | Hydraulic Jamar Dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440) |
| Body Balance | Until the conclusion of the study, on average 14 months | Timed Up and Go Test (TUG) |
| Lower limb sensitivity | until the conclusion of the study, on average 14 months | Esthesiometer (monofilaments) |
| Satisfaction with the use of photobiomodulation | Until the conclusion of the study, on average 14 months | Questions will be asked about overall satisfaction with the management of peripheral neuropathy |
| Assessment of Adherence to Treatment | 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. |
| Impact of Peripheral Neuropathy on Activities of Daily Living | Until the conclusion of the study, on average 14 months | Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ) |
| Health-related quality of life | 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) |
Countries
Brazil
Outcome results
None listed