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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
72
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 is a standard treatment that is applied to prevent hair loss during chemotherapy.
Jessa Hospital
Hasselt, Limburg, Belgium
RECRUITINGHair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Time frame: Baseline
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Time frame: 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.
Time frame: 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.
Time frame: One month post chemotherapy
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Time frame: Baseline
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Time frame: Halfway into their chemotherapy (An average of 6 weeks)
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Time frame: At the final chemotherapy session (An average of 12 weeks)
CTCAE-score
The patient may grade their hair loss using the CTCAE criteria.
Time frame: One month post chemotherapy
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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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: One month post chemotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: One month post chemotherapy