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Recruiting NCT02792270

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Trial Parameters

Condition Tumor Surgery
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2016-06
Completion 2026-04
Interventions
Caloric Restriction Diet

Brief 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)

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