Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04481802
Eligibility Criteria:
Inclusion Criteria:
1. Female patients
2. Age \> 18
3. Patients with histologically-confirmed diagnosis of breast cancer
4. Patients after breast lumpectomy and that scheduled to receive radiotherapy
5. Patients to receive minimum of 40.05 Gy to primary field
6. Must be able to comply with treatment schedule
7. Study-specific signed informed consent prior to randomization
Exclusion Criteria:
1. Inflammatory or connective tissue disorders of the skin
2. Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires
3. Previous radiation therapy to the breast
4. Tumour involvement of the skin
5. Rash, ulceration or open wound in treatment field
6. Known skin allergy or sensitivity to Aloe Vera or Biafine
7. Current lactation
8. Pregnancy
9. Any other reason that, in the opinion of the investigator, prevents the subject from
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT04481802
Study Brief:
Protocol Section:
NCT04481802