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Peripheral Nervous System Diseases AND Breast NeoplasmsNCT05663723

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

A study testing Intervention group with the IV and V LED board and Intervention group with the IV, V and Violet LED board in people with Peripheral Nervous System Diseases AND Breast Neoplasms, run by Erica Alves Nogueira Fabro at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Intervention group with the IV and V LED board and Intervention group with the IV, V and Violet LED board
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
1 siteBrazil
Study dates
8 Mar 2023to 4 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Erica Alves Nogueira Fabro

    Rio de Janeiro, 20530-003

Other trials in Brazil

About this study

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).

Read the 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.

Being tested
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
Keywords
Breast cancer, Peripheral neuropathy, Chemotherapy, Photobiomodulation
Medical subject headings
Breast Neoplasms, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention group with the IV and V LED boardDevice

    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 group with the IV, V and Violet LED boardDevice

    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.

  • Control group with LED board without emitting lightDevice

    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.

Study groups in NCT05663723
Study groupRoleWhat they receive
Intervention group with the IV and V LED boardActive comparatorTime 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.
Receives: Device: Intervention group with the IV and V LED board
Intervention group with the IV, V and Violet LED boardActive comparatorTime 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.
Receives: Device: Intervention group with the IV, V and Violet LED board
Control group with LED board without emitting lightPlacebo comparatorApplications 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
Receives: Device: Control group with LED board without emitting light

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral neuropathy

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

    Measured: Until the conclusion of the study, on average 14 months

Secondary outcomes (8)

  1. Lower limb pain

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

    Measured: Until the conclusion of the study, on average 14 months

  2. Overall Muscle Strength

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

    Measured: Until the conclusion of the study, on average 14 months

  3. Body Balance

    Timed Up and Go Test (TUG)

    Measured: Until the conclusion of the study, on average 14 months

  4. Lower limb sensitivity

    Esthesiometer (monofilaments)

    Measured: until the conclusion of the study, on average 14 months

  5. 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)

    Measured: Until the conclusion of the study, on average 14 months

  6. Satisfaction with the use of photobiomodulation

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

    Measured: Until the conclusion of the study, on average 14 months

  7. 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.

    Measured: Until the conclusion of the study, on average 14 months

  8. Impact of Peripheral Neuropathy on Activities of Daily Living

    Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ)

    Measured: Until the conclusion of the study, on average 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start8 Mar 2023
  3. Primary completion4 Jun 2024
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663723
Sponsor's protocol ID
Prevention of neuropathy
Status last verified
Jun 2025
First submitted
30 Nov 2022
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andrade, L.C.A; Costa G.L.A. and other Timed Up and Go test in assessing the risk of falls in the elderly: a literature review. Research, Society and Development. 2021, 10(13):1-7.

  • Alberto, Talita; Corbo, B.F.B; e outros Efeitos do emissor de luz (LED) vermelho na estimulação de fibroblastos: ansiedade na emoção tecidual. Revista Intellectus. Vol 1, n. 33 de 2016.

  • Andreo L, Soldera CB, Ribeiro BG, de Matos PRV, Bussadori SK, Fernandes KPS, Mesquita-Ferrari RA. Effects of photobiomodulation on experimental models of peripheral nerve injury. Lasers Med Sci. 2017 Dec;32(9):2155-2165. doi: 10.1007/s10103-017-2359-7. Epub 2017 Oct 23.

    PubMed 29063472

  • Argenta PA, Ballman KV, Geller MA, Carson LF, Ghebre R, Mullany SA, Teoh DG, Winterhoff BJ, Rivard CL, Erickson BK. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecol Oncol. 2017 Jan;144(1):159-166. doi: 10.1016/j.ygyno.2016.11.013. Epub 2016 Nov 22.

    PubMed 27887804

  • Rafael Inácio Barbosa, R.I; Marcolino A.M; Guirro R.R.J; Nilton Mazzer, Nilton; et al. Efeito do laser de baixa intensidade (660 nm) na regeneração do nervo isquiático lesado em ratos. Fisioterapia e Pesquisa, São Paulo, v.17, n.4, p. 294-9, out/dez. 2010.

  • Bensadoun RJ, Bollet MA, Liem X, Cao K, Magne N. New photobiomodulation device for prevention and cure of radiotherapy-induced oral mucositis and dermatitis: results of the prospective Safe PBM study. Support Care Cancer. 2022 Feb;30(2):1569-1577. doi: 10.1007/s00520-021-06574-2. Epub 2021 Sep 19.

    PubMed 34537889

  • Bethesda, MD: National Cancer Institute. PDQ® Adult Treatment Editorial Board. PDQ Breast Cancer Treatment (Adult). Available at: https://www.cancer.gov/types/breast/hp/breast-treatment-pdq. Accessed August 10th, 2022.

  • Brasil. Ministério da Saúde; Instituto Nacional de Câncer José Alencar Gomes da Silva. Ações de enfermagem para o controle do câncer: uma proposta de integração ensino-serviço. Rio de Janeiro: INCA; 2008. Bases do tratamento; p. 369-556.

  • Beliche T.W.O; Hamu T.C.D.S. et al. Diferenças de aplicação do teste timed up and go em crianças típicas. Revista Temas em Saúde, v. 20, n°1, p. 95-103. João Pessoa,2020.

  • Bretan O, Silva Junior JE, Ribeiro OR, Corrente JE. Risk of falling among elderly persons living in the community: assessment by the Timed up and go test. Braz J Otorhinolaryngol. 2013 Jan-Feb;79(1):18-21. doi: 10.5935/1808-8694.20130004.

    PubMed 23503902

  • Calhoun EA, Welshman EE, Chang CH, Lurain JR, Fishman DA, Hunt TL, Cella D. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer. 2003 Nov-Dec;13(6):741-8. doi: 10.1111/j.1525-1438.2003.13603.x.

    PubMed 14675309

  • Costa TC, Lopes M, Anjos AC, Zago MM. [Chemotherapy-induced peripheral neuropathies: an integrative review of the literature]. Rev Esc Enferm USP. 2015 Apr;49(2):335-45. doi: 10.1590/S0080-623420150000200020. Portuguese.

    PubMed 25992834

  • DUTRA M. C; CABRAL A. L. L, CARVALHO G. A. Tradução para o português e validação do teste timed up and go. Revista Interfaces. Saúde, Humanas e Tecnologia. Vol. 3(9), pp. 81-88, 22 de Abril, 2016

  • Fisusi FA, Akala EO. Drug Combinations in Breast Cancer Therapy. Pharm Nanotechnol. 2019;7(1):3-23. doi: 10.2174/2211738507666190122111224.

    PubMed 30666921

  • Fernandes A.A; Marins J.C.B. Teste de força de preensão manual: análise metodológica e dados normativos em atletas. Fisioter. mov. 24 (3). Set 2011.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group with the IV and V LED board and Intervention group with the IV, V and Violet LED board in people with Peripheral Nervous System Diseases AND Breast Neoplasms, run by Erica Alves Nogueira Fabro at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral neuropathy (time frame: Until the conclusion of the study, on average 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663723, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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