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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Low-level laser
sham laser
radiotherapy
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Jessa Hospital - Oncology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Control group

Arm Description

Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)

Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)

Outcomes

Primary Outcome Measures

Radiation Dermatitis Grade
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)
Radiation Dermatitis Grade
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)
Radiation Dermatitis Grade
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)
Radiation Dermatitis Grade
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)
Radiation Dermatitis Grade
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)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of trans epidermal water loss of the skin
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of the skin hydration
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of trans epidermal water loss of the skin
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of degree of erythema of the skin
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

Secondary Outcome Measures

Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Quality of life
Health-related quality of life measure specific to skin diseases
Quality of life
Health-related quality of life measure specific to skin diseases
Quality of life
Health-related quality of life measure specific to skin diseases
Quality of life
Health-related quality of life measure specific to skin diseases
Quality of life
Health-related quality of life measure specific to skin diseases
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation

Full Information

First Posted
May 11, 2015
Last Updated
July 25, 2019
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02443493
Brief Title
Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients
Acronym
TRANSDERMIS
Official Title
Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
Intervention Type
Device
Intervention Name(s)
Low-level laser
Other Intervention Name(s)
LLLT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham laser
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Primary Outcome Measure Information:
Title
Radiation Dermatitis Grade
Description
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)
Time Frame
day 1
Title
Radiation Dermatitis Grade
Description
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)
Time Frame
day 20
Title
Radiation Dermatitis Grade
Description
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)
Time Frame
day 33
Title
Radiation Dermatitis Grade
Description
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)
Time Frame
day 40
Title
Radiation Dermatitis Grade
Description
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)
Time Frame
day 54
Title
Radiation Dermatitis Assessment
Description
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
day 1
Title
Radiation Dermatitis Assessment
Description
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
day 20
Title
Radiation Dermatitis Assessment
Description
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
day 33
Title
Radiation Dermatitis Assessment
Description
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
day 40
Title
Radiation Dermatitis Assessment
Description
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
day 54
Title
Objective measurement of trans epidermal water loss of the skin
Description
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Time Frame
day 1
Title
Objective measurement of trans epidermal water loss of the skin
Description
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Time Frame
day 20
Title
Objective measurement of trans epidermal water loss of the skin
Description
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Time Frame
day 33
Title
Objective measurement of trans epidermal water loss of the skin
Description
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Time Frame
day 40
Title
Objective measurement of trans epidermal water loss of the skin
Description
Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Time Frame
day 54
Title
Objective measurement of the skin hydration
Description
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Time Frame
day 1
Title
Objective measurement of the skin hydration
Description
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Time Frame
day 20
Title
Objective measurement of the skin hydration
Description
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Time Frame
day 33
Title
Objective measurement of the skin hydration
Description
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Time Frame
day 40
Title
Objective measurement of trans epidermal water loss of the skin
Description
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Time Frame
day 54
Title
Objective measurement of degree of erythema of the skin
Description
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Time Frame
day 1
Title
Objective measurement of degree of erythema of the skin
Description
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Time Frame
day 20
Title
Objective measurement of degree of erythema of the skin
Description
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Time Frame
day 33
Title
Objective measurement of degree of erythema of the skin
Description
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Time Frame
day 40
Title
Objective measurement of degree of erythema of the skin
Description
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Time Frame
day 54
Title
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Description
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Time Frame
day 1
Title
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Description
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Time Frame
day 20
Title
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Description
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Time Frame
day 33
Title
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Description
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Time Frame
day 40
Title
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Description
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Time Frame
day 54
Secondary Outcome Measure Information:
Title
Pain
Description
Evaluation of pain using a Visual Analogue Scale (VAS)
Time Frame
day 1
Title
Pain
Description
Evaluation of pain using a Visual Analogue Scale (VAS)
Time Frame
day 20
Title
Pain
Description
Evaluation of pain using a Visual Analogue Scale (VAS)
Time Frame
day 33
Title
Pain
Description
Evaluation of pain using a Visual Analogue Scale (VAS)
Time Frame
day 40
Title
Pain
Description
Evaluation of pain using a Visual Analogue Scale (VAS)
Time Frame
day 54
Title
Quality of life
Description
Health-related quality of life measure specific to skin diseases
Time Frame
day 1
Title
Quality of life
Description
Health-related quality of life measure specific to skin diseases
Time Frame
day 20
Title
Quality of life
Description
Health-related quality of life measure specific to skin diseases
Time Frame
day 33
Title
Quality of life
Description
Health-related quality of life measure specific to skin diseases
Time Frame
day 40
Title
Quality of life
Description
Health-related quality of life measure specific to skin diseases
Time Frame
day 54
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time Frame
day 1
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time Frame
day 20
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time Frame
day 33
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time Frame
day 40
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time Frame
day 54
Title
moist desquamation
Description
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time Frame
day 1
Title
moist desquamation
Description
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time Frame
day 20
Title
moist desquamation
Description
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time Frame
day 33
Title
moist desquamation
Description
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time Frame
day 40
Title
moist desquamation
Description
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time Frame
day 54

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeroen Mebis, prof. dr.
Organizational Affiliation
Universiteit Hasselt/ Jessa ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital - Oncology department
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients

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