Clinical trial · Interventional
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
NCT02792270CI-TRIAL-00111777recruitingN/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)
This study is being conducted to decrease the rate of surgical wound complications. The investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.
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 |
|---|---|---|---|
| Tumor Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caloric Restriction Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Caloric Restriction Diet
- description
- Patients will meet with the Registered Dietitian to discuss calorie, protein, and fluid needs.The dietitian will calculate calorie needs. * Calorie needs will be reduced by 30%. * Protein needs will be estimated based on 0.8g/kg BW and then reduced by 70%. * Dietitian will educate participants on electrolytes and fluid intake based on the reduced food intake.
- interventionNames
- Other: Caloric Restriction Diet
- type
- NO_INTERVENTION
- label
- Normal Diet
- description
- Participant will follow a normal diet.
Primary outcomes (2)
- measure
- Change In The Rate Of Physical Function By MSTS
- timeFrame
- Baseline, 6 weeks, 3 months and 6 months visits after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Biopsy proven soft tissue sarcoma located in the lower extremities * Patient to be treated with radiation therapy for a primary lower extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection * Karnofsky Score ≥ 60% * Body Mass Index (BMI) ≥ 20 kg/m2 * Protein levels within normal limits within 45 days of enrollment * Normal kidney and liver function within 45 days of enrollment * Normal blood counts within 45 days of enrollment * Normal chemistries within 45 days of enrollment Exclusion Criteria: * Current pregnancy and breast feeding * Other cancers diagnosed within the last 5 years (in situ and/or invasive) * Diabetes mellitus * Current metformin therapy * Other conditions may exclude participants from the study (e.g. intractable nausea/emesis, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)
References
Publications (0)
Data not yet available
No reference posted for this study.