Patients operated for breast cancer who undergo postoperative adjuvant radiotherapy will be offered to participate in this randomized trial with the aim to reduce the risk of severe radiation skin reactions MedDRA version: 12.1 Level: LLT Classification code 10006199 Term: Breast cancer stage I MedDRA version: 12.1 Level: LLT Classification code 10006200 Term: Breast cancer stage II
Conditions
Interventions
Trade Name: Calendula Salva
Product Name: Calendula salva Weleda
Pharmaceutical Form: Ointment
Trade Name: Essex kräm
Product Name: Essex kräm
Pharmaceutical Form: Cream
Sponsors
Dept of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Radical surgery for breast cancer 2. 18 years or older 3. Planned for adjuvant radiotherapy 4. Signed informed consent 5. Resident in the Stockholm health care region 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Impaired cognitive status 2. Does not speak or understand Swedish 3. Severely impaired general health, according to ECOG performance status 4. Previous radiotherapy to the same anatomic site 5. Known allergy from Calendula 6. Concomitant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to study if skin care with Calendula cream reduces the risk of radiation skin reactions compared with Essex cream in patients with breast cancer undergoing postoperative radiotherapy ;Secondary Objective: Differences in frequency and severity concerning patient reported pain, itching, sleeping difficulties, and Quality of Life between patients randomized to skin care with Calendula cream vs Essex cream. Differences in frequency and severity concerning radiation skin reactions, patient reported pain, itching and sleeping difficulties between smokers and non smokers, both within the two treatment arms and in the entire study population. ;Primary end point(s): Frequency of radiation skin reactions in patients with breast cancer undergoing radiotherapy after use of skin care with either Calendula cream or Essex cream | — |
Countries
Sweden
Outcome results
None listed