Clinical trial NCT05177289: Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia
Official title: Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Alopecia
Keywords: Photobiomodulation therapy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hair thickness measurement
timeFrame: Baseline
measure: Hair thickness measurement
timeFrame: Halfway into their chemotherapy (An average of 6 weeks)
measure: Hair thickness measurement
timeFrame: At the final chemotherapy session (An average of 12 weeks)
measure: Hair thickness measurement
timeFrame: One month post chemotherapy
measure: CTCAE-score
timeFrame: Baseline
measure: CTCAE-score
timeFrame: Halfway into their chemotherapy (An average of 6 weeks)
measure: CTCAE-score
timeFrame: At the final chemotherapy session (An average of 12 weeks)
measure: CTCAE-score
timeFrame: One month post chemotherapy
measure: Hair loss evaluation
timeFrame: Baseline
measure: Hair loss evaluation
timeFrame: Halfway into their chemotherapy (An average of 6 weeks)
measure: Hair loss evaluation
timeFrame: At the final chemotherapy session (An average of 12 weeks)
measure: Hair loss evaluation
timeFrame: One month post chemotherapy
Secondary outcomes:
measure: Quality of life score
timeFrame: Baseline
measure: Quality of life score
timeFrame: Halfway into their chemotherapy (An average of 6 weeks)
measure: Quality of life score
timeFrame: At the final chemotherapy session (An average of 12 weeks)
measure: Quality of life score
timeFrame: One month post chemotherapy
measure: Satisfaction score
timeFrame: Halfway into their chemotherapy (An average of 6 weeks)
measure: Satisfaction score
timeFrame: At the final chemotherapy session (An average of 12 weeks)
measure: Satisfaction score
timeFrame: One month post chemotherapy
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
measure: General patient-, disease-, and treatment-related information
timeFrame: One month post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: One year post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Two years post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Three years post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Four years post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Five years post chemotherapy
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Jeroen Mebis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: