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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02443493
Date of registration:	11/05/2015
Prospective Registration:	No
Primary sponsor:	Hasselt University
Public title:	Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients TRANSDERMIS
Scientific title:	Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
Date of first enrolment:	April 2015
Target sample size:	139
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02443493
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Belgium

Contacts

Name:	Jeroen Mebis, prof. dr.
Address:
Telephone:
Email:
Affiliation:	Universiteit Hasselt/ Jessa ziekenhuis

Key inclusion & exclusion 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)

Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Device: Low-level laser

Device: sham laser

Radiation: radiotherapy

Primary Outcome(s)

Objective measurement of the skin hydration [Time Frame: day 40]

Radiation Dermatitis Assessment [Time Frame: day 20]

Radiation Dermatitis Assessment [Time Frame: day 33]

Radiation Dermatitis Assessment [Time Frame: day 54]

Objective measurement of degree of erythema of the skin [Time Frame: day 1]

Objective measurement of trans epidermal water loss of the skin [Time Frame: day 40]

Objective measurement of trans epidermal water loss of the skin [Time Frame: day 33]

Objective measurement of trans epidermal water loss of the skin [Time Frame: day 54]

Radiation Dermatitis Grade [Time Frame: day 33]

Radiation Dermatitis Grade [Time Frame: day 54]

Analyze the skin cytokine content of the irradiated and non-irradiated breast [Time Frame: day 33]

Objective measurement of degree of erythema of the skin [Time Frame: day 33]

Objective measurement of degree of erythema of the skin [Time Frame: day 40]

Objective measurement of degree of erythema of the skin [Time Frame: day 20]

Objective measurement of the skin hydration [Time Frame: day 20]

Analyze the skin cytokine content of the irradiated and non-irradiated breast [Time Frame: day 40]

Objective measurement of degree of erythema of the skin [Time Frame: day 54]

Objective measurement of the skin hydration [Time Frame: day 1]

Analyze the skin cytokine content of the irradiated and non-irradiated breast [Time Frame: day 54]

Objective measurement of trans epidermal water loss of the skin [Time Frame: day 1]

Radiation Dermatitis Assessment [Time Frame: day 40]

Objective measurement of trans epidermal water loss of the skin [Time Frame: day 20]

Radiation Dermatitis Grade [Time Frame: day 1]

Radiation Dermatitis Assessment [Time Frame: day 1]

Analyze the skin cytokine content of the irradiated and non-irradiated breast [Time Frame: day 1]

Radiation Dermatitis Grade [Time Frame: day 20]

Analyze the skin cytokine content of the irradiated and non-irradiated breast [Time Frame: day 20]

Objective measurement of the skin hydration [Time Frame: day 33]

Radiation Dermatitis Grade [Time Frame: day 40]

Secondary Outcome(s)

Quality of life [Time Frame: day 54]

Satisfaction with therapy [Time Frame: day 20]

Satisfaction with therapy [Time Frame: day 33]

moist desquamation [Time Frame: day 1]

Pain [Time Frame: day 20]

Pain [Time Frame: day 40]

moist desquamation [Time Frame: day 40]

Pain [Time Frame: day 1]

Quality of life [Time Frame: day 1]

moist desquamation [Time Frame: day 33]

moist desquamation [Time Frame: day 54]

Quality of life [Time Frame: day 33]

Quality of life [Time Frame: day 40]

Satisfaction with therapy [Time Frame: day 54]

Satisfaction with therapy [Time Frame: day 40]

moist desquamation [Time Frame: day 20]

Pain [Time Frame: day 33]

Pain [Time Frame: day 54]

Quality of life [Time Frame: day 20]

Satisfaction with therapy [Time Frame: day 1]

Secondary ID(s)

15.38/onco15.06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jessa Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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