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Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy (LABRA)

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ClinicalTrials.gov Identifier: NCT03924011
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
Jessa Hospital
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Prof. dr. Jeroen Mebis, Hasselt University

Brief Summary:

Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.

Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.

Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.

The results of this project will support the implementation of PBMT into the standard RD skincare program.


Condition or disease Intervention/treatment Phase
Radiodermatitis Breast Cancer Device: Photobiomodulation therapy (PBMT) Device: Sham laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Sham Comparator: Control group
Receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Device: Sham laser
Sham laser sessions will be applied 2x/week after RT.

Experimental: Treatment group
Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Device: Photobiomodulation therapy (PBMT)
PBMT sessions will be planned 2x/week after RT.
Other Name: Low-level light therapy (LLLT)




Primary Outcome Measures :
  1. Radiation Dermatitis Grade [ Time Frame: week 1 ]
    Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  2. Radiation Dermatitis Grade [ Time Frame: week 2 ]
    Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  3. Radiation Dermatitis Grade [ Time Frame: week 3 ]
    Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  4. Radiation Dermatitis Grade [ Time Frame: week 4 ]
    Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  5. Radiation Dermatitis Grade [ Time Frame: week 5 ]
    Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  6. Radiation Dermatitis Grade [ Time Frame: week 6 ]
    Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  7. Radiation Dermatitis Assessment [ Time Frame: week 1 ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  8. Radiation Dermatitis Assessment [ Time Frame: week 2 ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)

  9. Radiation Dermatitis Assessment [ Time Frame: week 3 ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)

  10. Radiation Dermatitis Assessment [ Time Frame: week 4 ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)

  11. Radiation Dermatitis Assessment [ Time Frame: week 5 ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)

  12. Radiation Dermatitis Assessment [ Time Frame: week 6 ]
    Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)


Secondary Outcome Measures :
  1. Pain evaluation: VAS [ Time Frame: week 1 ]
    Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

  2. Pain evaluation: VAS [ Time Frame: week 2 ]
    Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

  3. Pain evaluation: VAS [ Time Frame: week 3 ]
    Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

  4. Pain evaluation: VAS [ Time Frame: week 4 ]
    Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

  5. Pain evaluation: VAS [ Time Frame: week 5 ]
    Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

  6. Pain evaluation: VAS [ Time Frame: week 6 ]
    Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

  7. Quality of life assessment [ Time Frame: week 1 ]
    The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

  8. Quality of life assessment [ Time Frame: week 2 ]
    The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

  9. Quality of life assessment [ Time Frame: week 3 ]
    The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

  10. Quality of life assessment [ Time Frame: week 4 ]
    The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

  11. Quality of life assessment [ Time Frame: week 5 ]
    The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

  12. Quality of life assessment [ Time Frame: week 6 ]
    The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.



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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:

  • Informed Consent as documented by signature
  • Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
  • Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
  • Scheduled for postoperative radiotherapy at Ziekenhuis Oost-Limburg, Genk:
  • Hypofractionated radiotherapy regimen (i.e. 16 daily fractions of 2.66 Gray to the whole breast followed by a boost of 5 fractions of 2.66 Gray to the tumor bed, 5x/week)

Exclusion Criteria:

  • Scheduled for postoperative radiotherapy at Jessa Hospital, Hasselt, Belgium
  • Previous irradiation to the same breast
  • Metastatic disease
  • Concurrent chemotherapy
  • Required use of bolus material to deliver radiotherapy (i.e material placed on the to-be- irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psyschological disorders, dementia, etc. of the participant
  • Seizure
  • Disorders triggered by lighttake anticoagulants
  • Hemorrhagic diatheses
  • Pregnancy
  • Suspected of carrying serious infectious disease
  • HIV positive history

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): NCT03924011


Contacts
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Contact: Jeroen Mebis, Prof. Dr. 003211 33 79 79 jeroen.mebis@jessazh.be
Contact: Jolien Robijns, PhD 003211337229 jolien.robijns@uhasselt.be

Locations
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Belgium
Ziekenhuis Oost-Limburg Campus St.-Jan Recruiting
Genk, Limburg, Belgium, 3600
Contact: Jolien Robijns, PhD       jolien.robijns@uhasselt.be   
Principal Investigator: Evelyn Van de Werf, MD         
Jessa Ziekenhuis Not yet recruiting
Hasselt, Belgium, 3500
Contact: Jolien Robijns, PhD    003211337229    jolien.robijns@uhasselt.be   
Principal Investigator: Jeroen Mebis, MD, PhD         
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Ziekenhuis Oost-Limburg
Investigators
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Study Director: Jolien Robijns, PhD Hasselt University
Additional Information:
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Responsible Party: Prof. dr. Jeroen Mebis, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03924011    
Other Study ID Numbers: 75
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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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 Prof. dr. Jeroen Mebis, Hasselt University:
Radiodermatitis
Breast cancer
Radiotherapy
Photobiomodulation therapy
Low-level light therapy
Skin diseases
Radiation injuries
Wounds and injuries
Oncology
Additional relevant MeSH terms:
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Breast Neoplasms
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Dermatitis
Radiation Injuries
Wounds and Injuries