Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia (HairLight)

September 28, 2023 updated by: Jessa Hospital

Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
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.
Device: Theradome® 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.
Device: Scalp cooling
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.
Active Comparator: Control group
Patients allocated to the control group will receive scalp cooling during their CTx course.
Device: Scalp cooling
Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hair thickness measurement
Time Frame: Baseline
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
Baseline
Hair thickness measurement
Time Frame: Halfway into their chemotherapy (An average of 6 weeks)
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
Time Frame: At the final chemotherapy session (An average of 12 weeks)
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
Time Frame: One month post chemotherapy
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
One month post chemotherapy
CTCAE-score
Time Frame: Baseline
The patient may grade their hair loss using the CTCAE criteria.
Baseline
CTCAE-score
Time Frame: Halfway into their chemotherapy (An average of 6 weeks)
The patient may grade their hair loss using the CTCAE criteria.
Halfway into their chemotherapy (An average of 6 weeks)
CTCAE-score
Time Frame: At the final chemotherapy session (An average of 12 weeks)
The patient may grade their hair loss using the CTCAE criteria.
At the final chemotherapy session (An average of 12 weeks)
CTCAE-score
Time Frame: One month post chemotherapy
The patient may grade their hair loss using the CTCAE criteria.
One month post chemotherapy
Hair loss evaluation
Time Frame: 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'.
Baseline
Hair loss evaluation
Time Frame: Halfway into their chemotherapy (An average of 6 weeks)
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
Time Frame: At the final chemotherapy session (An average of 12 weeks)
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
Time Frame: One month post chemotherapy
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: Baseline
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
Time Frame: Halfway into their chemotherapy (An average of 6 weeks)
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
Time Frame: At the final chemotherapy session (An average of 12 weeks)
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
Time Frame: 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.
One month post chemotherapy
Satisfaction score
Time Frame: 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).
Halfway into their chemotherapy (An average of 6 weeks)
Satisfaction score
Time Frame: At the final chemotherapy session (An average of 12 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).
At the final chemotherapy session (An average of 12 weeks)
Satisfaction score
Time Frame: One month post chemotherapy
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General patient-, disease-, and treatment-related information
Time Frame: 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).
Baseline
General patient-, disease-, and treatment-related information
Time Frame: One month post chemotherapy
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
Time Frame: One year post chemotherapy
The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
One year post chemotherapy
Cancer relapse or recurrence
Time Frame: Two years post chemotherapy
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Two years post chemotherapy
Cancer relapse or recurrence
Time Frame: Three years post chemotherapy
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Three years post chemotherapy
Cancer relapse or recurrence
Time Frame: Four years post chemotherapy
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Four years post chemotherapy
Cancer relapse or recurrence
Time Frame: Five years post chemotherapy
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Five years post chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jessa Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeroen Mebis, Prof. Dr., Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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