Trial · NCT03716583
Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer
NCT03716583, Phase 2, Completed, Dennis Bregner Zetner
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer. Trials, record NCT03716583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03716583
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer
- NCT number
- NCT03716583
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Dennis Bregner Zetner
- Conditions
- Radiation Dermatitis, Radiation Dermatitis Acute, Breast Cancer
- Interventions
- Melatonin, Dimethyl Sulfoxide, Placebos
- First posted
- 2018-10-23
- Last updated
- 2021-09-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin | 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 |
| Primary | Erythema evaluated through pixel analysis of clinical photographs | 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). |
| Primary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23) | 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. |
| Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core module (QLQ-C30) | Once weekly for 8 weeks | 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: 1. Not at all 2. A little 3. A lot 4. 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). |
| Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23) | 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. Item 1-19 are defined as a secondary outcomes outcome. |
| Secondary | Patient reported steroid cream usage | Once weekly for 8 weeks | 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) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03716583
GET https://conductscience.org/api/trials/v1/NCT03716583/registered