Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients

Breast Cancer Clinical Trial

— TRANSDERMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443493
• Other study ID #: 15.38/onco15.06
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiodermatitis

Intervention

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.
• 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

Locations

Country	Name	City	State
Belgium	Jessa Hospital - Oncology department	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	day 1
Primary	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)	day 20
Primary	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)	day 33
Primary	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)	day 40
Primary	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)	day 54
Primary	Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 1
Primary	Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 20
Primary	Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 33
Primary	Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 40
Primary	Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	day 54
Primary	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	day 1
Primary	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	day 20
Primary	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	day 33
Primary	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	day 40
Primary	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	day 54
Primary	Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 1
Primary	Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 20
Primary	Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 33
Primary	Objective measurement of the skin hydration	Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	day 40
Primary	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	day 54
Primary	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	day 1
Primary	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	day 20
Primary	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	day 33
Primary	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	day 40
Primary	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	day 54
Primary	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	day 1
Primary	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	day 20
Primary	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	day 33
Primary	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	day 40
Primary	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	day 54
Secondary	Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 1
Secondary	Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 20
Secondary	Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 33
Secondary	Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 40
Secondary	Pain	Evaluation of pain using a Visual Analogue Scale (VAS)	day 54
Secondary	Quality of life	Health-related quality of life measure specific to skin diseases	day 1
Secondary	Quality of life	Health-related quality of life measure specific to skin diseases	day 20
Secondary	Quality of life	Health-related quality of life measure specific to skin diseases	day 33
Secondary	Quality of life	Health-related quality of life measure specific to skin diseases	day 40
Secondary	Quality of life	Health-related quality of life measure specific to skin diseases	day 54
Secondary	Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 1
Secondary	Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 20
Secondary	Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 33
Secondary	Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 40
Secondary	Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	day 54
Secondary	moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 1
Secondary	moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 20
Secondary	moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 33
Secondary	moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 40
Secondary	moist desquamation	3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation	day 54