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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT00869466
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of early breast cancer
* Stage I-III disease
* Invasive or in situ disease
* No metastatic or inoperable disease
* Underwent primary surgery for primary breast cancer at UHSM, North Manchester, Royal Oldham, Stepping Hill, Hope Macclesfield General, Tameside General, Leighton Hospitals, or Rochdale Infirmary within the past 10 weeks
* Receiving/due to start adjuvant chemotherapy, radiotherapy, endocrine therapy, or no adjuvant treatment
* Hormonal receptor status not specified
PATIENT CHARACTERISTICS:
* Pre or postmenopausal status
* Any weight allowed
* Resident within Greater Manchester or Cheshire area
* No physical/psychiatric condition that impairs compliance or mobility as assessed from medical history or baseline fitness assessment, including any of the following:
* Insulin-requiring diabetes (non-insulin requiring diabetics are eligible)
* Serious digestive and/or absorptive problems, including inflammatory bowel disease
* Cardiovascular or respiratory disease
* Musculoskeletal disease or joint problems
* Psychiatric disorders or conditions (e.g., untreated major depression, psychosis, substance abuse, or severe personality disorder)
* Not considering reconstructive surgery in the next 12 months
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent daily medication known to affect body composition (e.g., corticosteroids)
* Patients receiving 2-3 days of steroids with chemotherapy are eligible
* No prior neoadjuvant chemotherapy or endocrine therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00869466
Study Brief:
Protocol Section:
NCT00869466