Clinical trial · Interventional
Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer
MELADERM-trial: Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer: a Pivotal Phase 2, Double-blind, Randomized, Placebo-controlled Trial
NCT03716583CI-TRIAL-00053825MELADERMcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
| Radiation Dermatitis Acute | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dimethyl Sulfoxide | Drug | — | UNRESOLVED |
| Melatonin | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Melatonin/DMSO
- description
- 25 mg melatonin in 1 g cream twice daily for the duration of the radiation therapy
- interventionNames
- Drug: Melatonin
- Drug: Dimethyl Sulfoxide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1 g of cream once daily
- interventionNames
- Drug: Placebos
Primary outcomes (3)
- measure
- Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin
- timeFrame
- Once weekly for 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.