Radiation DermatitisPhase 2MELADERMNCT03716583
Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer
A Phase 2 study testing Melatonin and Dimethyl Sulfoxide in people with Radiation Dermatitis and Radiation Dermatitis Acute, run by Dennis Bregner Zetner at 1 site in Denmark.
Trial summary
The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Radiation Dermatitis, Radiation Dermatitis Acute, Breast Cancer
- What is being tested?
- Melatonin and Dimethyl Sulfoxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2019to 31 Jan 2021
- Phase
- Phase 2
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with early breast cancer
- Over 49 years old
- Have had radical tumor resection surgery
- Follows treatment regimens and follow-up at Rigshospitalet
- Written informed consent after written and verbal information
Who cannot join
- Inability to understand Danish, written or spoken
- Mental illness (Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance)
- Previous therapy with ionizing radiation in the thoracic or neck area
- Use of bolus for radiation therapy (A bolus is a material which has dose absorption properties equivalent to tissue. It is placed on the irradiated area to alter dosing or target of the radiation therapy)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MELADERM-trial: Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer: a Pivotal Phase 2, Double-blind, Randomized, Placebo-controlled Trial
The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.
Read the detailed description
The study will be a randomized, placebo-controlled, double-blinded clinical pivotal trial. Patients will be allocated in a ratio of 1:1 to the melatonin or placebo group. Patients will be stratified according to the type of surgery (lumpectomy or mastectomy). Randomization will be performed in blocks of randomized sizes. The study will be performed in the Department of Oncology, Rigshospitalet, Denmark.
Eligible patients with early breast cancer receive adjuvant radiation therapy over 15 to 30 daily fractions (5 fractions per week) of ionizing megavoltage photon radiation to a total of 40 - 60 Gy within 3-5 weeks according to the guidelines of the Danish Breast Cancer Cooperative Group. In this study, the patients will administer approximately 1 g of cream containing melatonin (25 mg/g) and dimethyl sulfoxide (DMSO) (150 mg/g) or a placebo cream topically twice daily on the irradiated skin area. The patients are scheduled to do this every day from the first to the last fraction of radiation therapy, including the days where they do not receive radiation therapy. The investigators have chosen placebo as the comparator due to it being safe and the most reasonable method of evaluating any effects of the intervention. On days where the patients receive radiation, the melatonin/DMSO or placebo cream will be applied no less than 2 hours prior to radiation. Throughout the study, the patients will meet with an investigator once weekly who will monitor compliance and assess outcomes.
- Being tested
- Melatonin, Dimethyl Sulfoxide, Placebos
- Keywords
- melatonin
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
25 mg
Dimethyl SulfoxideDrug
150 mg
PlacebosDrug
1 g
| Study group | Role | What they receive |
|---|---|---|
| Melatonin/DMSO | Experimental | 25 mg melatonin in 1 g cream twice daily for the duration of the radiation therapy Receives: Drug: Melatonin; Drug: Dimethyl Sulfoxide |
| Placebo | Placebo comparator | 1 g of cream once daily Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin
This scale ranges from 0 to 4, being:
0: No change over baseline
- Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating
- Tender or bright erythema, patchy moist desquamation/moderate edema
- Confluent, moist desquamation other than skin folds, pitting edema
- Ulceration, hemorrhage, necrosis
Measured: Once weekly for 8 weeks
Erythema evaluated through pixel analysis of clinical photographs
Erythema has previously been evaluated by a validated method using software analysis (Image J, version 1.45S, National Institute of health, USA) of digital photos [32]. A "color space converter" function will be used to convert the clinical photos into grayscale in the software analysis. Erythema will be quantified by pixel color analyses where all white colored pixels represent erythema. An a*-value will represent degree of erythema (high a*-values represent a high degree of erythema).
Measured: Once weekly for 8 weeks
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)
The quality of life questionnaire determines patient-reported quality of life through a series of questions. All questions in the BR23-module (Breast cancer module) are answered on a scale of 1-4, meaning:
- Not at all
- A little
- A lot
- Very much The questions vary between symptoms, feelings and activities of daily living.
Only item 20-23 (specifically questions about the breast area) are defined as a primary outcome. All other outcomes in the questionnaire are considered secondary outcomes.
Measured: Once weekly for 8 weeks
Secondary outcomes (3)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core module (QLQ-C30)
The quality of life questionnaire determines patient-reported quality of life through a series of questions. 28 of 30 questions in the C30-module (Core questionnaire) are answered on a scale of 1-4, meaning:
- Not at all
- A little
- A lot
- Very much The questions vary between symptoms, feelings and activities of daily living.
The remaining two questions are answered on a scale of 1 (Very bad) to 7 (Very well).
Measured: Once weekly for 8 weeks
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)
The quality of life questionnaire determines patient-reported quality of life through a series of questions. All questions in the BR23-module (Breast cancer module) are answered on a scale of 1-4, meaning:
- Not at all
- A little
- A lot
- Very much The questions vary between symptoms, feelings and activities of daily living.
Item 1-19 are defined as a secondary outcomes outcome.
Measured: Once weekly for 8 weeks
Patient reported steroid cream usage
Patients will be questioned once weekly about usage of steroid cream. The questions will be:
Have you used any steroid cream throughout your radiation therapy? (Yes/No) If yes, when did you begin using steroid cream? (Date) If yes, how many days have you used steroid cream? (Number of days)
Measured: Once weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start30 Apr 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis Bregner Zetner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dennis Bregner Zetner, Herlev Hospital
- Investigators
- Dennis B Zetner, MD, Principal investigator, Center for Perioperativ Optimization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716583
- Sponsor's protocol ID
- 2018-001705-91
- Other IDs
- 2018
- Acronym
- MELADERM
- Status last verified
- Sep 2021
- First submitted
- 16 Oct 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MELADERM-trial: Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer: a Pivotal Phase 2, Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03716583
- Acronym / sponsor ID
- MELADERM / 2018-001705-91
- Keywords
- melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dennis Bregner ZetnerUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- 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.
The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.
Detailed description
The study will be a randomized, placebo-controlled, double-blinded clinical pivotal trial. Patients will be allocated in a ratio of 1:1 to the melatonin or placebo group. Patients will be stratified according to the type of surgery (lumpectomy or mastectomy). Randomization will be performed in blocks of randomized sizes. The study will be performed in the Department of Oncology, Rigshospitalet, Denmark.
Eligible patients with early breast cancer receive adjuvant radiation therapy over 15 to 30 daily fractions (5 fractions per week) of ionizing megavoltage photon radiation to a total of 40 - 60 Gy within 3-5 weeks according to the guidelines of the Danish Breast Cancer Cooperative Group. In this study, the patients will administer approximately 1 g of cream containing melatonin (25 mg/g) and dimethyl sulfoxide (DMSO) (150 mg/g) or a placebo cream topically twice daily on the irradiated skin area. The patients are scheduled to do this every day from the first to the last fraction of radiation therapy, including the days where they do not receive radiation therapy. The investigators have chosen placebo as the comparator due to it being safe and the most reasonable method of evaluating any effects of the intervention. On days where the patients receive radiation, the melatonin/DMSO or placebo cream will be applied no less than 2 hours prior to radiation. Throughout the study, the patients will meet with an investigator once weekly who will monitor compliance and assess outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin/DMSO | Experimental | Drug: Melatonin, Drug: Dimethyl Sulfoxide25 mg melatonin in 1 g cream twice daily for the duration of the radiation therapy |
| Placebo | Placebo comparator | Drug: Placebos1 g of cream once daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with early breast cancer
- Over 49 years old
- Have had radical tumor resection surgery
- Follows treatment regimens and follow-up at Rigshospitalet
- Written informed consent after written and verbal information
Key exclusion criteria (5 listed)
- Inability to understand Danish, written or spoken
- Mental illness (Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance)
- Previous therapy with ionizing radiation in the thoracic or neck area
- Use of bolus for radiation therapy (A bolus is a material which has dose absorption properties equivalent to tissue. It is placed on the irradiated area to alter dosing or target of the radiation therapy)
- Pregnancy
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 |
|---|---|---|
| Melatonin25 mg | Drug | Melatonin/DMSO |
| Dimethyl Sulfoxide150 mg | Drug | Melatonin/DMSO |
| Placebos1 g | Drug | Placebo |
Primary outcome
Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin
Time frame: Once weekly for 8 weeks
This scale ranges from 0 to 4, being: 0: No change over baseline 1. Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating 2. Tender or bright erythema, patchy moist desquamation/moderate edema 3. Confluent, moist desquamation other than skin folds, pitting edema 4. Ulceration, hemorrhage, necrosis
Erythema evaluated through pixel analysis of clinical photographs
Time frame: Once weekly for 8 weeks
Erythema has previously been evaluated by a validated method using software analysis (Image J, version 1.45S, National Institute of health, USA) of digital photos [32]. A "color space converter" function will be used to convert the clinical photos into grayscale in the software analysis. Erythema will be quantified by pixel color analyses where all white colored pixels represent erythema. An a*-value will represent degree of erythema (high a*-values represent a high degree of erythema).
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)
Time frame: Once weekly for 8 weeks
The quality of life questionnaire determines patient-reported quality of life through a series of questions. All questions in the BR23-module (Breast cancer module) are answered on a scale of 1-4, meaning: 1. Not at all 2. A little 3. A lot 4. Very much The questions vary between symptoms, feelings and activities of daily living. Only item 20-23 (specifically questions about the breast area) are defined as a primary outcome. All other outcomes in the questionnaire are considered secondary outcomes.
3 secondary outcomes
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core module (QLQ-C30)
Time frame: Once weekly for 8 weeks
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)
Time frame: Once weekly for 8 weeks
Patient reported steroid cream usage
Time frame: Once weekly for 8 weeks
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 10 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Dennis B Zetner, MD principal investigator
Center for Perioperativ Optimization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin and Dimethyl Sulfoxide in people with Radiation Dermatitis and Radiation Dermatitis Acute, run by Dennis Bregner Zetner at 1 site in Denmark.
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 5 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 10 Sep 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin (time frame: Once weekly for 8 weeks). 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 10 Sep 2021.