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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01082003
Eligibility Criteria:
Inclusion Criteria:
* Female subjects
* \> 18 years of age
* Expected survival at least \> 6 months
* Undergone mastectomy with expander or implant reconstruction \> 3 weeks before radiation therapy
* Completed chest wall irradiation in the past two weeks
* Willing to stop herbal medications as directed by physician
* Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E component is acceptable)
* Willing to travel to a Legacy Health System facility
* Agree to attend study visits outside of standard of care visits
* Normal PT-INR for subjects taking Coumadin
Exclusion Criteria:
* \< 18 years of age
* Pregnant or lactating
* Have final implant placed \< 3 weeks before start of radiation therapy
* Have evidence of ongoing infection or implant exposure before start of radiation therapy
* Radiation completed more than 16 days prior to study start
* Retinitis Pigmentosa
* Unable to comply with protocol
* Unable to provide written informed consent
* Unwilling or unable to stop supplemental vitamin E
* PT-INR outside of acceptable range for subjects taking Coumadin
* Investigator does not believe study participation, for any reason is in the best interest of the patient
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01082003
Study Brief:
Protocol Section:
NCT01082003