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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Jeroen Mebis, Prof. Dr.; 003211 33 79 79; jeroen.mebis@jessazh.be

Contact: Jolien Robijns, PhD; 003211337229; jolien.robijns@uhasselt.be

Locations

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

• Study Director: Jolien Robijns, PhD; Hasselt University

More Information

Additional Information:

Limburg Oncologic Center 

• Responsible Party: Prof. dr. Jeroen Mebis, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT03924011
• Other Study ID Numbers: 75
• First Posted: April 23, 2019
• Last Update Posted: April 23, 2019
• Last Verified: April 2019

• 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:

Breast Neoplasms; Radiodermatitis; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries