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Trial record 2 of 2 for:    theradome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05177289
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Jessa Hospital

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Alopecia Device: Theradome® LH80 pro Device: Scalp cooling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Hair thickness measurement [ Time Frame: Baseline ]
    The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

  2. 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.

  3. 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.

  4. 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.

  5. CTCAE-score [ Time Frame: Baseline ]
    The patient may grade their hair loss using the CTCAE criteria.

  6. CTCAE-score [ Time Frame: Halfway into their chemotherapy (An average of 6 weeks) ]
    The patient may grade their hair loss using the CTCAE criteria.

  7. 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.

  8. CTCAE-score [ Time Frame: One month post chemotherapy ]
    The patient may grade their hair loss using the CTCAE criteria.

  9. 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'.

  10. 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'.

  11. 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'.

  12. 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'.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05177289


Contacts
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Contact: Jeroen Mebis, Prof. Dr. +32 11 33 72 21 jeroen.mebis@jessazh.be
Contact: Marithé Claes, MSc +32 11 33 72 39 marithe.claes@uhasselt.be

Locations
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Belgium
Jessa Hospital Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Jeroen Mebis, Prof. Dr.    +32 11 33 72 21    jeroen.mebis@jessazh.be   
Contact: Marithé Marithé, MSc    +32 11 33 72 39    marithe.claes@uhasselt.be   
Sponsors and Collaborators
Jessa Hospital
Investigators
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Principal Investigator: Jeroen Mebis, Prof. Dr. Jessa Hospital
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Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT05177289    
Other Study ID Numbers: 2021/117
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessa Hospital:
Photobiomodulation therapy
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical