Clinical trial · Observational
Weight Control Programs in Women Who Have Undergone Surgery for Early Stage Breast Cancer
B- AHEAD Study (Breast - Activity & Healthy Eating After Diagnosis) Randomised Comparison of 3 Weight Control Programmes During Adjuvant Treatment for Early Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| support group therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
Secondary outcomes (14)
- measure
- Uptake and retention of information about the interventions and adverse effects of the interventions
- measure
- Changes in quality of life as assessed by FACT-B, B-ES, and -F at baseline and at 6 and 12 months
- measure
- Changes in markers of breast cancer prognosis at baseline and at 6 and 12 months
- measure
- Changes in insulin resistance and glucose homeostasis model assessment (HOMA) at baseline and at 6 and 12 months
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available