NCT02443493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

May 11, 2015

Last Update Submit

July 25, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (30)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Radiation Dermatitis Assessment

    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

    day 1

  • Radiation Dermatitis Assessment

    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

    day 20

  • Radiation Dermatitis Assessment

    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

    day 33

  • Radiation Dermatitis Assessment

    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

    day 40

  • Radiation Dermatitis Assessment

    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

    day 54

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (20)

  • Pain

    day 1

  • Pain

    day 20

  • Pain

    day 33

  • Pain

    day 40

  • Pain

    day 54

  • +15 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Device: Low-level laserRadiation: radiotherapy

Control group

SHAM COMPARATOR

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

Device: sham laserRadiation: radiotherapy

Interventions

Low-level laserDEVICE

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.

Also known as: LLLT
Treatment group
sham laserDEVICE

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.

Control group
radiotherapyRADIATION
Control groupTreatment group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital - Oncology department

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Low-Level Light TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Jeroen Mebis, prof. dr.

    Universiteit Hasselt/ Jessa ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 13, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

BE(1)