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Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients (TRANSDERMIS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443493
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Prof. dr. Jeroen Mebis, Hasselt University

Brief Summary:

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent pilot study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot study was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in breast cancer patients.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Low-level laser Device: sham laser Radiation: radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
Actual Study Start Date : April 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment group
Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
Device: Low-level laser
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
Other Name: LLLT

Radiation: radiotherapy
Sham Comparator: Control group
Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
Device: sham laser
Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.

Radiation: radiotherapy



Primary Outcome Measures :
  1. Radiation Dermatitis Grade [ Time Frame: day 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)

  2. Radiation Dermatitis Grade [ Time Frame: day 20 ]
    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: day 33 ]
    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: day 40 ]
    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: day 54 ]
    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 Assessment [ Time Frame: day 1 ]
    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  7. Radiation Dermatitis Assessment [ Time Frame: day 20 ]
    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  8. Radiation Dermatitis Assessment [ Time Frame: day 33 ]
    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  9. Radiation Dermatitis Assessment [ Time Frame: day 40 ]
    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  10. Radiation Dermatitis Assessment [ Time Frame: day 54 ]
    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  11. Objective measurement of trans epidermal water loss of the skin [ Time Frame: day 1 ]
    Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

  12. Objective measurement of trans epidermal water loss of the skin [ Time Frame: day 20 ]
    Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

  13. Objective measurement of trans epidermal water loss of the skin [ Time Frame: day 33 ]
    Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

  14. Objective measurement of trans epidermal water loss of the skin [ Time Frame: day 40 ]
    Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

  15. Objective measurement of trans epidermal water loss of the skin [ Time Frame: day 54 ]
    Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

  16. Objective measurement of the skin hydration [ Time Frame: day 1 ]
    Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

  17. Objective measurement of the skin hydration [ Time Frame: day 20 ]
    Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

  18. Objective measurement of the skin hydration [ Time Frame: day 33 ]
    Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

  19. Objective measurement of the skin hydration [ Time Frame: day 40 ]
    Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

  20. Objective measurement of trans epidermal water loss of the skin [ Time Frame: day 54 ]
    Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

  21. Objective measurement of degree of erythema of the skin [ Time Frame: day 1 ]
    Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin

  22. Objective measurement of degree of erythema of the skin [ Time Frame: day 20 ]
    Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin

  23. Objective measurement of degree of erythema of the skin [ Time Frame: day 33 ]
    Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin

  24. Objective measurement of degree of erythema of the skin [ Time Frame: day 40 ]
    Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin

  25. Objective measurement of degree of erythema of the skin [ Time Frame: day 54 ]
    Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin

  26. Analyze the skin cytokine content of the irradiated and non-irradiated breast [ Time Frame: day 1 ]
    Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

  27. Analyze the skin cytokine content of the irradiated and non-irradiated breast [ Time Frame: day 20 ]
    Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

  28. Analyze the skin cytokine content of the irradiated and non-irradiated breast [ Time Frame: day 33 ]
    Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

  29. Analyze the skin cytokine content of the irradiated and non-irradiated breast [ Time Frame: day 40 ]
    Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

  30. Analyze the skin cytokine content of the irradiated and non-irradiated breast [ Time Frame: day 54 ]
    Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA


Secondary Outcome Measures :
  1. Pain [ Time Frame: day 1 ]
    Evaluation of pain using a Visual Analogue Scale (VAS)

  2. Pain [ Time Frame: day 20 ]
    Evaluation of pain using a Visual Analogue Scale (VAS)

  3. Pain [ Time Frame: day 33 ]
    Evaluation of pain using a Visual Analogue Scale (VAS)

  4. Pain [ Time Frame: day 40 ]
    Evaluation of pain using a Visual Analogue Scale (VAS)

  5. Pain [ Time Frame: day 54 ]
    Evaluation of pain using a Visual Analogue Scale (VAS)

  6. Quality of life [ Time Frame: day 1 ]
    Health-related quality of life measure specific to skin diseases

  7. Quality of life [ Time Frame: day 20 ]
    Health-related quality of life measure specific to skin diseases

  8. Quality of life [ Time Frame: day 33 ]
    Health-related quality of life measure specific to skin diseases

  9. Quality of life [ Time Frame: day 40 ]
    Health-related quality of life measure specific to skin diseases

  10. Quality of life [ Time Frame: day 54 ]
    Health-related quality of life measure specific to skin diseases

  11. Satisfaction with therapy [ Time Frame: day 1 ]
    Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

  12. Satisfaction with therapy [ Time Frame: day 20 ]
    Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

  13. Satisfaction with therapy [ Time Frame: day 33 ]
    Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

  14. Satisfaction with therapy [ Time Frame: day 40 ]
    Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

  15. Satisfaction with therapy [ Time Frame: day 54 ]
    Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

  16. moist desquamation [ Time Frame: day 1 ]
    3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation

  17. moist desquamation [ Time Frame: day 20 ]
    3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation

  18. moist desquamation [ Time Frame: day 33 ]
    3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation

  19. moist desquamation [ Time Frame: day 40 ]
    3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation

  20. moist desquamation [ Time Frame: day 54 ]
    3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
  • Signed informed consent

Exclusion Criteria:

  • 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 the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)

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): NCT02443493


Locations
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Belgium
Jessa Hospital - Oncology department
Hasselt, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Jeroen Mebis, prof. dr. Universiteit Hasselt/ Jessa ziekenhuis
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Responsible Party: Prof. dr. Jeroen Mebis, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02443493    
Other Study ID Numbers: 15.38/onco15.06
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
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