Breast Cancer Clinical Trial
Official title:
B- AHEAD Study (Breast - Activity & Healthy Eating After Diagnosis) Randomised Comparison of 3 Weight Control Programmes During Adjuvant Treatment for Early Breast Cancer.
Verified date | March 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Observational |
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 is not yet known which program is most effective in women with breast
cancer.
PURPOSE: This randomized clinical trial is comparing three weight control programs to see
how well they work in women who have undergone surgery for early stage breast cancer.
Status | Completed |
Enrollment | 409 |
Est. completion date | February 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
N/A
Country | Name | City | State |
---|---|---|---|
United Kingdom | Christie Hospital | Manchester | England |
United Kingdom | Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital | Manchester | England |
United Kingdom | South Manchester University Hospital | Manchester | England |
United Kingdom | Wellcome Trust Clinical Research Facility | Manchester | England |
United Kingdom | Cancer Care Research Centre at University of Stirling | Stirling | England |
Lead Sponsor | Collaborator |
---|---|
Wythenshawe Hospital |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) at baseline and at 6 and 12 months | No | ||
Secondary | Uptake and retention of information about the interventions and adverse effects of the interventions | No | ||
Secondary | Changes in quality of life as assessed by FACT-B, B-ES, and -F at baseline and at 6 and 12 months | No | ||
Secondary | Changes in markers of breast cancer prognosis at baseline and at 6 and 12 months | No | ||
Secondary | Changes in insulin resistance and glucose homeostasis model assessment (HOMA) at baseline and at 6 and 12 months | No | ||
Secondary | Cardiovascular disease-risk markers (i.e., total LDL and HDL cholesterol, triglycerides, and systolic/diastolic blood pressure) at baseline and at 6 and 12 months | No | ||
Secondary | Changes in fitness as assessed by a 12-minute walk test at baseline and at 6 and 12 months | No | ||
Secondary | Changes in arm mobility, function (as assessed by quick DASH), and pain (as assessed by pain rating scale and S-LANSS for neuropathic pain) at baseline and at 6 and 12 months | No | ||
Secondary | Changes in dietary intake (as assessed by a 7-day food diary) and activity (as assessed by a 7-day activity diary) as measures of compliance at baseline and at 6 and 12 months | No | ||
Secondary | Changes in serum bone markers/bone specific alkaline phosphatase for bone formation and the cross linked C-telopeptides of type I collagen for bone resorption at baseline and at 6 and 12 months | No | ||
Secondary | Changes in ipsilateral arm circumference (compared to contralateral arm) using perometer in patients having axillary node clearance at baseline and at 6 and 12 months | No | ||
Secondary | Changes in generic health status and quality of life (as assessed by EQ-5D utility measure) and health resource usage to assess the relative cost effectiveness of the interventions at baseline and at 3, 6, and 12 months | No | ||
Secondary | Changes in isometric and isokinetic muscle strength of quadriceps in patients receiving aromatase inhibitors and age-matched patients receiving tamoxifen in a subset of patients in the standard written only group | No | ||
Secondary | Patient experience of interventions through in-depth focus group discussions and individual interviews | No | ||
Secondary | Factors predicting adherence to interventions with scales of stage of behavior change for weight control and exercise | No |
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