Clinical trial · Interventional
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery
NCT02983279CI-TRIAL-00089063completedN/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)
The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.
Conditions
Conditions (3)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Carcinosarcoma | Prostate Acinar Sarcomatoid Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counseling | Other | — | UNRESOLVED |
| Dietary Intervention | Dietary Supplement | — | UNRESOLVED |
| Therapeutic | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary counseling, caloric restriction diet
- description
- Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
- interventionNames
- Dietary Supplement: Dietary Intervention
- Other: Counseling
- Procedure: Therapeutic
Primary outcomes (1)
- measure
- Change in miR-21 expression assessed in serum
- timeFrame
- Baseline up to 12 weeks
- description
- Will be evaluated by a two-sided paired t-test at significance level 0.05.
Secondary outcomes (21)
- measure
- Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.