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Completed

NCT Number: NCT02443493

Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital - Oncology department

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Low-level laser

Device

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 names: LLLT

sham laser

Device

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.

Radiotherapy

Radiation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients

Acronym: TRANSDERMIS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 13, 2015
Registry last updated
Jul 26, 2019

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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