Radiation dermatitis MedDRA version: 20.0 Level: LLT Classification code 10061103 Term: Dermatitis radiation System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.1 Level: PT Classification code 10063562 Term: Radiation skin injury System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Melatonin
Pharmaceutical Form: Cream
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Center for Perioperative Optimization, Department of Surgery, Herlev Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Inability to understand Danish, written or spoken Mental illness* Previous therapy with ionizing radiation in the thoracic or neck area Use of bolus for radiation therapy** * Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance. ** 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if melatonin can protect against radiation injury in women receiving radiation therapy as part of their treatment of breast cancer.;Secondary Objective: To evaluate if melatonin can reduce the useage of steroid cream in the treatment of radiaiton dermatitis.;Primary end point(s): RTOG's acute radiation morbidity scoring criteria of the skin Image analysis of clinical photographs after radiation exposure EORTC's QLQ-BR23, specifically the breast symptoms;Timepoint(s) of evaluation of this end point: RTOG's acute radiation morbidity scoring criteria of the skin: Two weeks after last radiation fraction Image analysis of clinical photographs after radiation exposure: Two weeks after last radiation fraction EORTC's QLQ-BR23, specifically the breast symptoms: Last day of radiation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): RTOG's acute radiation morbidity scoring criteria of the skin Image analysis of clinical photographs after radiation exposure EORTC's QLQ-BR23 Useage of steroid cream throughout the trial;Timepoint(s) of evaluation of this end point: Once weekly during the radiation treatment, and once weekly for 3 weeks following the last radiation fraction | — |
Countries
Denmark
Contacts
Public ContactDennis Bregner Zetner
Center for Perioperative Optimization, Department of Surgery, Herlev Hospital
Outcome results
None listed