Radiation DermatitisDERMISNCT01932073
Laser Therapy for the Management of Radiation Dermatitis
A study testing Low-Level Laser Therapy in people with Radiation Dermatitis, run by Hasselt University at 1 site in Belgium.
Trial summary
Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Low-Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma
- Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
- Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
- Provide signed informed consent
Who cannot join
- Previous irradiation to the same breast
- Metastatic disease
- Mastectomy surgery
- Concurrent chemo-radiotherapy
- Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients
Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.
LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.
- Conditions
- Radiation Dermatitis
- Being tested
- Low-Level Laser Therapy
- Keywords
- Radiation, dermatitis, radiodermatitis, radiotherapy induced, skin reactions, low level laser therapy, breast cancer
- Medical subject headings
- Radiodermatitis, Dermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyDevice
Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Receives institutional skin care protocol |
| Treatment Group | Experimental | Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy Receives: Device: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months (during radiation therapy and one month after)
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: 3 months (during radiation therapy and one month after)
Pain
evaluation of pain using a visual analogue scale
Measured: 3 months (during radiation therapy and one month after)
Secondary outcomes (3)
Quality of Life
Health-related quality of life measure specific to skin diseases (Skindex-16)
Measured: 3 months (during radiation therapy and one month after)
Impact of Radiation Dermatitis
Self-report on the impact of radiation dermatitis on daily activities
Measured: 3 months (during radiation therapy and one month after)
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis
Measured: 3 months (during radiation therapy and one month after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. Jeroen Mebis, Hasselt University
- Investigators
- Jeroen Mebis, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932073
- Sponsor's protocol ID
- 13.43/onco13.05
- Acronym
- DERMIS
- Status last verified
- Dec 2014
- First submitted
- 27 Aug 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01932073
- Acronym / sponsor ID
- DERMIS / 13.43/onco13.05
- Conditions
- Radiation Dermatitis
- Keywords
- Radiation, dermatitis, radiodermatitis, radiotherapy induced, skin reactions, low level laser therapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.
LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Receives institutional skin care protocol |
| Treatment Group | Experimental | Device: Low-Level Laser TherapyReceives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma
- Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment
- Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week)
- Provide signed informed consent
Key exclusion criteria (5 listed)
- Previous irradiation to the same breast
- Metastatic disease
- Mastectomy surgery
- Concurrent chemo-radiotherapy
- Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser TherapyLow-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful | Device | Treatment Group |
Primary outcome
Radiation Dermatitis Grade
Time frame: 3 months (during radiation therapy and one month after)
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: 3 months (during radiation therapy and one month after)
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Pain
Time frame: 3 months (during radiation therapy and one month after)
evaluation of pain using a visual analogue scale
3 secondary outcomes
Quality of Life
Time frame: 3 months (during radiation therapy and one month after)
Impact of Radiation Dermatitis
Time frame: 3 months (during radiation therapy and one month after)
Satisfaction with therapy
Time frame: 3 months (during radiation therapy and one month after)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Mebis, MD, PhD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy in people with Radiation Dermatitis, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dermatitis Grade (time frame: 3 months (during radiation therapy and one month after)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.