Clinical trial · Interventional
Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight
Use of a Soy-Based Meal Replacement Weight Loss Intervention for Survivors of ER/PR Negative Breast Cancer
NCT00343434CI-TRIAL-00025544completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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: A diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life. PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in helping women with stage I, stage II, or stage III breast cancer in complete remission lose weight.
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 |
| Obesity | — | 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 |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| soy isoflavones | Dietary Supplement | — | UNRESOLVED |
| soy protein isolate | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Previously diagnosed stage I-III breast cancer currently in complete remission * Completed treatment for breast cancer ≥ 6 months ago * Free of disease at last clinic visit * Body mass index ≥ 27 * Hormone receptor status * Estrogen receptor (ER)/progesterone receptor (PR) negative PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * No history of soy allergies * No uncontrolled blood pressure * No uncontrolled hyperthyroidism or hypothyroidism * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No diabetes mellitus (type 1 or 2) * No medical, psychiatric, or behavioral factors that would preclude study participation * No definite plans to move out of the area during the study period PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent medications for weight loss * No concurrent treatment for ER/PR-negative disease
References
Publications (0)
Data not yet available
No reference posted for this study.