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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chemotherapy-induced Alopecia

Intervention / Treatment
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* Device: Theradome® LH80 pro
* Device: Scalp cooling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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 pro<br>* 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.<br>Device: Scalp cooling<br>* Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.<br>|
| Active Comparator: Control group<br>Patients allocated to the control group will receive scalp cooling during their CTx course. | Device: Scalp cooling<br>* Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life. | Baseline | 
| Quality of life score | The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life. | Halfway into their chemotherapy (An average of 6 weeks) | 
| Quality of life score | The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life. | At the final chemotherapy session (An average of 12 weeks) | 
| Quality of life score | The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life. | One month post chemotherapy | 
| Satisfaction score | 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). | Halfway into their chemotherapy (An average of 6 weeks) | 
| Satisfaction score | 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). | At the final chemotherapy session (An average of 12 weeks) | 
| Satisfaction score | 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). | One month post chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photobiomodulation therapy