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Recruiting NCT02792270

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Conditions: Tumor Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Massachusetts General Hospital

Location: Massachusetts general Hospital Boston Massachusetts

Summary

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.

Eligibility Criteria

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02792270). StuddyBuddy aggregates publicly available trial information.