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NCT Number: NCT03924011

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

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.

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Key information

Conditions

Radiodermatitis Breast Cancer Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg Campus St.-Jan, Genk, Limburg, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation therapy (PBMT)

Device

PBMT sessions will be planned 2x/week after RT.

Other names: Low-level light therapy (LLLT)

sham laser

Device

Sham laser sessions will be applied 2x/week after RT.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial

Acronym: LABRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2019
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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