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This study examines a calorie-restriction dietary intervention and counseling given before surgery in patients with endometrial, prostate or breast cancer. It enrolled patients who were candidates for definitive cancer surgery and had a body mass index of 21 or higher. This was a study with no assigned phase and it has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Histological documentation of cancer of the endometrium, prostate or breast. 2. Candidate for definitive cancer surgery as determined by treating physician 3. The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis - but from start of diet). 4. No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion 5. BMI ≥21 6. ECOG Performance Status of 2 or less 7. Patient must not be on anti-retrovirals since they may alter patient metabolism Exclusion Criteria: 1. Patient is not a candidate for definitive cancer surgery 2. Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment as determined by the enrolling physician. 3. Body Mass Index \< 21 4. Another malignancy within the past 6 months that was not a non-melanomatous skin lesion 5. ECOG Performance Status \>2 6. Patient on anti-retrovirals since they may alter patient metabolism