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NCT Number: NCT05177289

Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia

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.

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Key information

Conditions

Chemotherapy-induced Alopecia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: chemotherapy-induced alopecia (CIA). 65% of cancer patients receiving cytotoxic drugs experience CIA, which negatively impacts their QoL, as hair loss is often associated with impaired body image and increased depression rates. Up to now, prevention of CIA is based on scalp cooling, but this treatment has a highly variable success rate. Photobiomodulation (PBM) therapy is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBM can be used to improve wound healing, and to reduce pain, inflammation, and edema. Research shows that PBM can stimulate hair growth by increasing the blood flow to the scalp and stimulating the catagen or telogen metabolism of the hair follicle. However, the effect of PBM on CIA has not been adequately investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Theradome® LH80 pro

Device

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.

scalp cooling

Device

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

Primary outcomes

  1. Hair thickness measurement

    Time frame: Baseline

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

  2. Hair thickness measurement

    Time frame: Halfway into their chemotherapy (An average of 6 weeks)

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

  3. Hair thickness measurement

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

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

  4. Hair thickness measurement

    Time frame: One month post chemotherapy

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

  5. CTCAE-score

    Time frame: Baseline

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

  6. CTCAE-score

    Time frame: Halfway into their chemotherapy (An average of 6 weeks)

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

  7. CTCAE-score

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

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

  8. CTCAE-score

    Time frame: One month post chemotherapy

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

  9. Hair loss evaluation

    Time frame: Baseline

    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'.

  10. Hair loss evaluation

    Time frame: Halfway into their chemotherapy (An average of 6 weeks)

    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'.

  11. Hair loss evaluation

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

    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'.

  12. Hair loss evaluation

    Time frame: One month post chemotherapy

    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'.

Secondary outcomes

  1. Quality of life score

    Time frame: Baseline

    The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

  2. Quality of life score

    Time frame: Halfway into their chemotherapy (An average of 6 weeks)

    The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

  3. Quality of life score

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

    The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

  4. Quality of life score

    Time frame: One month post chemotherapy

    The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

  5. Satisfaction score

    Time frame: Halfway into their chemotherapy (An average of 6 weeks)

    The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).

  6. Satisfaction score

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

    The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).

  7. Satisfaction score

    Time frame: One month post chemotherapy

    The patients will be asked to evaluate their global satisfaction with the therapeutic intervention. The patients will score their satisfaction regarding their treatment on the NRS scale 0 (totally not satisfied) to 10 (very satisfied).

Other outcomes

  1. General patient-, disease-, and treatment-related information

    Time frame: Baseline

    General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).

  2. General patient-, disease-, and treatment-related information

    Time frame: One month post chemotherapy

    General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).

  3. Cancer relapse or recurrence

    Time frame: One year post chemotherapy

    The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  4. Cancer relapse or recurrence

    Time frame: Two years post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  5. Cancer relapse or recurrence

    Time frame: Three years post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  6. Cancer relapse or recurrence

    Time frame: Four years post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  7. Cancer relapse or recurrence

    Time frame: Five years post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Mebis, Prof. Dr.

CONTACT

[email protected]

+32 11 33 72 21

Marithé Claes, MSc

CONTACT

[email protected]

+32 11 33 72 39

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial

Acronym: HairLight

Important dates

Study start
2022
Primary completion
2025
Study completion
2030
First posted
Jan 4, 2022
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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