About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Metastatic disease
Pregnancy
Active infection of the scalp
Previous diagnosis of a hair loss condition
Trial design
Parallel
Treatments tested in this trial
Theradome® LH80 pro
DeviceThe 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
DeviceScalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
Treatment groups
Trial outcomes
Primary outcomes
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Hair thickness measurement
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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).
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).
Cancer relapse or recurrence
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Cancer relapse or recurrence
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Sponsors and contacts
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