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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Active Comparator | Patients allocated to the control group will receive scalp cooling during their CTx course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| General patient-, disease-, and treatment-related information | 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). | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeroen Mebis, Prof. Dr. | Contact | +32 11 33 72 21 | jeroen.mebis@jessazh.be | |
| Marithé Claes, MSc | Contact | +32 11 33 72 39 | marithe.claes@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, Prof. Dr. | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Recruiting | Hasselt | Limburg | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40705170 | Derived | 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. |
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| Scalp cooling | Device | Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy. |
|
| 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 |
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 |
| General patient-, disease-, and treatment-related information | 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). | One month post chemotherapy |
| Cancer relapse or recurrence | The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | One year post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Two years post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Three years post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Four years post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Five years post chemotherapy |