Clinical trial · Interventional
Diet and Exercise or Normal Care in Overweight or Obese Women Who Have Undergone Treatment for Stage I, Stage II, or Stage III Breast Cancer
The Effects of a Combined Diet and Exercise Intervention on Biomarkers Associated With Disease Recurrence After Breast Cancer Treatment: The Sheffield DEBRA Trial
- 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: Studying diet and exercise interventions in overweight and obese patients with breast cancer may help doctors learn more about how to help patients lose weight and change their body composition. PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it works compared with normal care in overweight or obese women who have undergone treatment for stage I, stage II, or stage III breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| complementary or alternative medicine procedure | Procedure | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| standard follow-up care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Body weight
- measure
- Body composition
Secondary outcomes (4)
- measure
- Pychological stress via the Perceived Stress Scale
- measure
- Depression via the Beck Depression Inventory II
- measure
- Cardiorespiratory fitness
- measure
- Quality of life via the FACT-G and FACT-B
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage I, II, or III breast cancer * No metastatic breast cancer * No inoperable or active loco-regional disease * Body mass index (BMI) \> 25 * Patients must have completed treatment for breast cancer within the past 3-18 months * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Willing and able to attend supervised exercise sessions at least 3 times per week for a period of 24 weeks * Patients must be an exercise pre-contemplator, contemplator, or preparer as defined by the transtheoretical model * No physical/psychiatric impairment that would seriously impair physical mobility * No severe nausea, anorexia, or other diseases affecting health (e.g., arthritis and multiple sclerosis) * More than 3 months since prior exercise and not currently engaged in exercise (two or more times per week for at least 30 minutes per session) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent tamoxifen, other endocrine treatments, and trastuzumab (Herceptin®) allowed * No concurrent alternative/complementary diets * No concurrent high-dose antioxidant supplement therapy * More than 4 months since prior and no concurrent hormone-replacement therapy or oral contraceptives
References
Publications (1)
- RESULTSaxton JM, Daley A, Woodroofe N, Coleman R, Powers H, Mutrie N, Siddall V, Crank H. Study protocol to investigate the effect of a lifestyle intervention on body weight, psychological health status and risk factors associated with disease recurrence in women recovering from breast cancer treatment [ISRCTN08045231]. BMC Cancer. 2006 Feb 9;6:35. doi: 10.1186/1471-2407-6-35. PMID 16469108