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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Peripheral Nervous System Diseases AND Breast Neoplasms
—
UNRESOLVED
—
Interventions
Interventions (3)
Intervention
Type
Mapped drug
Match
Control group with LED board without emitting light
Device
—
UNRESOLVED
Intervention group with the IV and V LED board
Device
—
UNRESOLVED
Intervention group with the IV, V and Violet LED board
Device
—
UNRESOLVED
Design
Arms and outcomes
Arms (3)
type
ACTIVE_COMPARATOR
label
Intervention group with the IV and V LED board
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.
interventionNames
Device: Intervention group with the IV and V LED board
type
ACTIVE_COMPARATOR
label
Intervention group with the IV, V and Violet LED board
description
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.
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (39)
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interventionNames
Device: Intervention group with the IV, V and Violet LED board
type
PLACEBO_COMPARATOR
label
Control group with LED board without emitting light
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. 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
interventionNames
Device: Control group with LED board without emitting light
Primary outcomes (1)
measure
Peripheral neuropathy
timeFrame
Until the conclusion of the study, on average 14 months
description
Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ), which is validated and translated from the Chemotherapy Induced Peripheral Neuropathy Assessment Tool - (CIPNAT).
Secondary outcomes (8)
measure
Lower limb pain
timeFrame
Until the conclusion of the study, on average 14 months
description
Short Form McGill Questionnaire, which is the McGill questionnaire in its shortened form
measure
Overall Muscle Strength
timeFrame
Until the conclusion of the study, on average 14 months
Until the conclusion of the study, on average 14 months
description
Timed Up and Go Test (TUG)
measure
Lower limb sensitivity
timeFrame
until the conclusion of the study, on average 14 months
description
Esthesiometer (monofilaments)
measure
Health-related quality of life
timeFrame
Until the conclusion of the study, on average 14 months
description
Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group - Neurotoxicity Questionnaire (FACT/GOG-NTX), Portuguese version FACT/GOG-NTX (Portuguese version)
measure
Satisfaction with the use of photobiomodulation
timeFrame
Until the conclusion of the study, on average 14 months
description
Questions will be asked about overall satisfaction with the management of peripheral neuropathy
measure
Assessment of Adherence to Treatment
timeFrame
Until the conclusion of the study, on average 14 months
description
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.
measure
Impact of Peripheral Neuropathy on Activities of Daily Living
timeFrame
Until the conclusion of the study, on average 14 months
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