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:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04543851
Eligibility Criteria:
Inclusion Criteria:
Patients diagnosed with completely excised stage I or II invasive breast cancer, or ductal carcinoma in situ (DCIS), who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy;
Any breast size with a skin fold of depth 1 cm or greater at the infra-mammary crease at the time of radiation treatment planning, or brassiere cup size equal to or larger than D;
Patients undergoing nodal radiotherapy are eligible if the above criteria are met;
Patients undergoing boost radiotherapy are eligible if the above criteria are met, but only if the surgical scar does not extend inferior to the nipple line of the breast;
Language is not a barrier if there are interpreters/family members to translate;
Patients having had chemotherapy are eligible for this study;
Exclusion Criteria:
Inability to give informed consent or comply with requirements of the trial;
Failure of healing of the surgical scar or significant post-operative wound infection;
Prior radiotherapy to either breast or to the chest;
Presence of significant connective tissue disease (e.g. systemic sclerosis); known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia);
Inability to return for assessment at both one week and two weeks following completion of radiotherapy;
Breast reconstruction;
Use of Mepitel® wound dressing product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04543851
Study Brief:
Protocol Section:
NCT04543851