Chemotherapy-induced Alopecia
Conditions
Keywords
Photobiomodulation therapy
Brief summary
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
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.
Interventions
DEVICETheradome® LH80 pro
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.
DEVICEScalp cooling
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
Sponsors
Jessa Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTCAE-score | Baseline | The patient may grade their hair loss using the CTCAE criteria. |
| Hair thickness measurement | Baseline | The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge. |
| Hair loss evaluation | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score | 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). |
| Quality of life score | Baseline | The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| General patient-, disease-, and treatment-related information | 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). |
| Cancer relapse or recurrence | One year post chemotherapy | The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records. |
Countries
Belgium
Contacts
Primary ContactJeroen Mebis, Prof. Dr.
Backup ContactMarithé Claes, MSc
Outcome results
None listed