NCT05177289

Brief Summary

This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started Feb 2022

Longer than P75 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 Progress53%
Feb 2022Jan 2030

First Submitted

Initial submission to the registry

December 9, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

December 9, 2021

Last Update Submit

September 28, 2023

Conditions

Chemotherapy-induced Alopecia

Keywords

Photobiomodulation therapy

Outcome Measures

Primary Outcomes (12)

  • Hair thickness measurement

    The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

    Baseline

  • Hair thickness measurement

    The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

    Halfway into their chemotherapy (An average of 6 weeks)

  • Hair thickness measurement

    The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

    At the final chemotherapy session (An average of 12 weeks)

  • Hair thickness measurement

    The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

    One month post chemotherapy

  • CTCAE-score

    The patient may grade their hair loss using the CTCAE criteria.

    Baseline

  • CTCAE-score

    The patient may grade their hair loss using the CTCAE criteria.

    Halfway into their chemotherapy (An average of 6 weeks)

  • CTCAE-score

    The patient may grade their hair loss using the CTCAE criteria.

    At the final chemotherapy session (An average of 12 weeks)

  • CTCAE-score

    The patient may grade their hair loss using the CTCAE criteria.

    One month post chemotherapy

  • Hair loss evaluation

    Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.

    Baseline

  • Hair loss evaluation

    Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.

    Halfway into their chemotherapy (An average of 6 weeks)

  • Hair loss evaluation

    Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.

    At the final chemotherapy session (An average of 12 weeks)

  • Hair loss evaluation

    Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.

    One month post chemotherapy

Secondary Outcomes (7)

  • Quality of life score

    Baseline

  • Quality of life score

    Halfway into their chemotherapy (An average of 6 weeks)

  • Quality of life score

    At the final chemotherapy session (An average of 12 weeks)

  • Quality of life score

    One month post chemotherapy

  • Satisfaction score

    Halfway into their chemotherapy (An average of 6 weeks)

  • +2 more secondary outcomes

Other Outcomes (7)

  • General patient-, disease-, and treatment-related information

    Baseline

  • General patient-, disease-, and treatment-related information

    One month post chemotherapy

  • Cancer relapse or recurrence

    One year post chemotherapy

  • +4 more other outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients allocated to the treatment group will receive scalp cooling combined with thrice weekly PBM sessions during the CTx course and until one month after the end of CTx.

Device: Theradome® LH80 proDevice: Scalp cooling

Control group

ACTIVE COMPARATOR

Patients allocated to the control group will receive scalp cooling during their CTx course.

Device: Scalp cooling

Interventions

Theradome® LH80 proDEVICE

The Theradome LH80 pro is a wearable laser helmet device, which uses red laser light to stop hair loss, thicken existing hair and stimulate the growth of new hair.

Treatment group
Scalp coolingDEVICE

Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.

Control groupTreatment group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer
  • Receiving chemotherapy ((Carbo)-Taxol)
  • Age ≥ 18 years
  • Able to comply to the study protocol
  • Able to sign written informed consent

You may not qualify if:

  • Metastatic disease
  • Pregnancy
  • Active infection of the scalp
  • Previous diagnosis of a hair loss condition
  • Interruption of chemotherapy for more than two consecutive cycles
  • Medication to stimulate hair growth (e.g., Minoxidil)
  • Severe psychological disorder or dementia.
  • Inability to speak and understand Dutch
  • Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
  • Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

Related Publications (1)

  • Claes M, Robijns J, Lambrichts L, Van Duffel S, Bulens P, Mebis J. Photobiomodulation therapy in the prevention of chemotherapy-induced alopecia in breast cancer patients: a randomized controlled trial. Lasers Med Sci. 2025 Jul 24;40(1):325. doi: 10.1007/s10103-025-04577-7.

    PMID: 40705170DERIVED

Study Officials

  • Jeroen Mebis, Prof. Dr.

    Jessa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Mebis, Prof. Dr.

CONTACT

+32 11 33 72 21jeroen.mebis@jessazh.be

Marithé Claes, MSc

CONTACT

+32 11 33 72 39marithe.claes@uhasselt.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 4, 2022

Study Start

February 28, 2022

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2030

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

BE(1)