NCT06995443

Brief Summary

Breast cancer is one of the most common cancers in metropolitan France, with over 60,000 new cases in 2023. Mostly a female cancer, it can affect a young population, with around 20% of breast cancers occurring in women under 50. Treatment is mainly based on surgery, chemotherapy, radiotherapy, targeted therapies and hormone therapy. Although chemotherapy is not systematically used, it remains a frequent treatment option. While chemotherapy makes a major contribution to curing cancer, it is also a source of potentially disabling side effects for survivors. Chemotherapy can interfere with the normal functioning of the central nervous system, leading to cognitive impairment. The number of people potentially affected by chemobrain is estimated at several tens of millions worldwide. There is no recommended treatment for people with chemobrain. Several avenues have been explored, with very limited results. Photobiomodulation (PBM) is a non-medicinal treatment technique that combines all the biological, athermic and non-cytotoxic effects of tissue exposure to non-ionizing sources of red and infrared light. Several studies have demonstrated the beneficial effects of cortical stimulation by photobiomodulation on memory (increased angiogenesis, increased oxygenation of brain tissue via vasodilatation, and increased mitochondrial ATP production). These positive biological effects are likely to ameliorate the undesirable effects of chemotherapy, and consequently the post-chemotherapy cognitive disorders that ensue.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

February 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

February 26, 2025

Last Update Submit

January 29, 2026

Conditions

OncologySupport CareCognitive Disorders

Keywords

Cognitive disordersPhotobiomodulationBreast canceroncology

Outcome Measures

Primary Outcomes (1)

  • To compare, among women aged 18 and over who had undergone chemotherapy for breast cancer and had subjective cognitive impairment post-chemotherapy, the rate of those showing improvement in cognitive impairment with or without photobiomodulation (cortica

    Patients with an evolution subjective cognitive performance between the FACT-Cog performed at inclusion and that at the end of follow-up (S13)

    From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

Secondary Outcomes (6)

  • Compare the rate of patients considered anxious in each group at inclusion (T0) and at the end of the follow-up period (S13)

    From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

  • To compare the rate of patients considered depressed in each group at inclusion (T0) and at the end of the follow-up period (S13)

    From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

  • Compare perceived sleep quality in each group at inclusion (T0) and at the end of the follow-up period (13)

    From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

  • Compare perceived health in each group at inclusion (T0) and at the end of the follow-up period (S13)

    From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

  • Describe in the experimental group only the evolution of the FACT-Cog score at the end of photobiomodulation treatment (S13) and at 6 months

    From follow-up visit at 13 weeks and 6 months after the first session of photobiomodulation (V1 + 6M +/-2W)

  • +1 more secondary outcomes

Study Arms (2)

Usual care with photobiomodulation sessions

EXPERIMENTAL

Photobiomodulation : 1 session per week during 12 weeks Visit 1 to Visit 4 : Photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : Cortical stimulation Visit 13 (V12 + 7 days +/- 3 days) : FACT-COG / anxiety measure / depression measure / Likert scale / satisfaction Visit 6 months (V1 + 6M +/- 2 weeks) : questionnary FACT-COG

Other: Photobiomodulation

Usual care

NO INTERVENTION

Interventions

PhotobiomodulationOTHER

12 sessions of photobiomodulation (1 per week) Visit 1 to 4 : photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : cortical stimulation (VEILIGHT)

Usual care with photobiomodulation sessions

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 18 years and over
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 and over
  • Having a perceived cognitive complaint that appeared during or after (\< 3 months) chemotherapy treatments (no restriction on the care protocol used) and confirmed by a FACT-Cog score compatible with a subjective cognitive disorder (score \< 117 for patients aged 18 to 49; score \< 113 for patients aged 50 to 69; score \<105 for patients aged 70 and over)
  • Patient eligible for photobiomodulation sessions
  • Patient with sufficient command of the French language to complete the study questionnaries
  • Patient having given written consent to participate in the trial
  • Socially insured patient
  • Patient willing to comply with all study procedures and duration

You may not qualify if:

  • Known cognitive disorders prior to chemotherapy treatment
  • Patients with psychiatric or psychobehavioral disorders incompatible with photobiomodulation sessions
  • Patient having previously received photobiomodulation with cortical stimulation (panel or helmet) with no time limit.
  • Patient taking or having received capecitabine
  • Patients taking part in a protocol involving a drug likely to affect cognitive performance (on the investigator's advice).
  • Patients suffering from claustrophobia
  • Patient unable to read and/or unable to complete a questionnaire, in the opinion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsCognitive DysfunctionBreast Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Lidvine GODAERT, MD

CONTACT

03.27.14.91.19godaert-l@ch-valenciennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2025

First Posted

May 29, 2025

Study Start

June 13, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

FR(1)