--- title: Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients nct_id: NCT02443493 overall_status: COMPLETED phase: NA sponsor: Hasselt University study_type: INTERVENTIONAL primary_condition: Breast Cancer countries: Belgium canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02443493.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02443493" ct_last_update_post_date: 2019-07-26 last_seen_at: "2026-05-12T07:26:23.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients **Official Title:** Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients **NCT ID:** [NCT02443493](https://clinicaltrials.gov/study/NCT02443493) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 139 - **Lead Sponsor:** Hasselt University - **Collaborators:** Jessa Hospital - **Conditions:** Breast Cancer - **Start Date:** 2015-04 - **Completion Date:** 2017-06 - **CT.gov Last Update:** 2019-07-26 ## 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. ## Eligibility - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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) ``` ## Arms - **Treatment group** (EXPERIMENTAL) — Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) - **Control group** (SHAM_COMPARATOR) — Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) ## Interventions - **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. - **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 - **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) - **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) - **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) - **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) - **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) - **Radiation Dermatitis Assessment** _(time frame: day 1)_ — radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) - **Radiation Dermatitis Assessment** _(time frame: day 20)_ — radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) - **Radiation Dermatitis Assessment** _(time frame: day 33)_ — radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) - **Radiation Dermatitis Assessment** _(time frame: day 40)_ — radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) - **Radiation Dermatitis Assessment** _(time frame: day 54)_ — radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **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 - **Pain** _(time frame: day 1)_ - **Pain** _(time frame: day 20)_ - **Pain** _(time frame: day 33)_ - **Pain** _(time frame: day 40)_ - **Pain** _(time frame: day 54)_ - **Quality of life** _(time frame: day 1)_ - **Quality of life** _(time frame: day 20)_ - **Quality of life** _(time frame: day 33)_ - **Quality of life** _(time frame: day 40)_ - **Quality of life** _(time frame: day 54)_ - **Satisfaction with therapy** _(time frame: day 1)_ - **Satisfaction with therapy** _(time frame: day 20)_ - **Satisfaction with therapy** _(time frame: day 33)_ - **Satisfaction with therapy** _(time frame: day 40)_ - **Satisfaction with therapy** _(time frame: day 54)_ - **moist desquamation** _(time frame: day 1)_ - **moist desquamation** _(time frame: day 20)_ - **moist desquamation** _(time frame: day 33)_ - **moist desquamation** _(time frame: day 40)_ - **moist desquamation** _(time frame: day 54)_ ## Locations (1) - Jessa Hospital - Oncology department, Hasselt, Belgium ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.jessa hospital - oncology department|hasselt||belgium` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02443493.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02443493* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*