Patients treated for the first time with radiotherapy to the residual breast after quadrantectomy for proven non-metastatic breast cancer. MedDRA version: 9.1 Level: HLGT Classification code 10014982 MedDRA version: 9.1 Level: LLT Classification code 10052164 MedDRA version: 9.1 Level: SOC Classification code 10038604 MedDRA version: 9.1 Level: HLT Classification code 10006289
Conditions
Interventions
Pharmaceutical Form: Cream
CAS Number: 08-59/02
Current Sponsor code: CREMA BASE ESSEX
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1-
Product Name: mar
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients receiving radiotherapy to the residual breast following quadrantectomy for histologically proven non-metastatic breast cancer. Age at diagnosis 18-75 years. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have received previous radiotherapy at the same site. Patients receiving radiotherapy only (no surgery). Patients with metastatic breast cancer. Patients with known allergy to one or both treatments (calendula or cortisone pomade). Patients receiving concomitant chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of acute cutaneous toxicity and cutaneous symptoms in breast cancer patients undergoing radiotherapy to residual breast after conservative surgery;Secondary Objective: 1. Compare radiotherapy doses that cause acute cutaneous reaction in the two study arms. 2. Analyze cutaneous toxicity and cutaneous symptoms according to study arm, and also in relation to the skin characteristics of treated patients. 3. Compare discomfort related to acute cutaneous toxicity in the two study arms. 4. Assess patient satisfaction with each of the two skin treatments. 5. Assess secondary cutaneous effects in the two study arms (e.g. cutaneous atrophy, telangiectasia, scarring, and pigmentation) 6-12 months after the completion of radiotherapy.;Primary end point(s): To demonstrate the superiority of the calendula pomade over placebo cream with fluorcortolone added in case of erythema, in preventing acute cutaneous toxicity grade 2 (ROTG), grade 2 erythema, and sub-acute skin lesions evaluated 3-6 months after the conclusion of radiotherapy in patients treated for the first time with radiotherapy to the residual breast following quadrantectomy for histologically proven, non-metastatic breast cancer | — |
Countries
Italy
Outcome results
None listed