Status:
COMPLETED
Weight Control Programs in Women Who Have Undergone Surgery for Early Stage Breast Cancer
Lead Sponsor:
Wythenshawe Hospital
Conditions:
Breast Cancer
Weight Changes
Eligibility:
FEMALE
18+ years
Brief Summary
RATIONALE: Measuring changes in body weight and body composition in women with early-stage breast cancer may help doctors plan the best weight control program and improve patients' quality of life. It...
Detailed Description
OBJECTIVES: Primary * To assess changes in body weight and composition (i.e., body fat, fat-free mass, dual energy x-ray absorptiometry, bioelectrical impedance, and waist and hip circumference) in ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00869466
Start Date
August 1 2008
End Date
February 1 2011
Last Update
April 4 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Wellcome Trust Clinical Research Facility
Manchester, England, United Kingdom, M13 9WL
2
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
3
Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LT
4
South Manchester University Hospital
Manchester, England, United Kingdom, M23 9LT