RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

OTHER

Caloric Restriction Diet

Two nutritional supplements, one from Ensure (Abbott Laboratories, Chicago, IL) and one from Boost (Nestle, Vevey, Switzerland) will be used for 3 days before surgery. The supplements are the Ensure Pre-Surgery Clear Carbohydrate Drink and the Ensure Original Nutrition Powder. The Original Nutrition Powder will be mixed with 8oz of water, oat milk, or almond milk. The proposed macronutrient profile for the 3 days of caloric restriction (CR) is less than 8% of calories from protein.

Locations (1)

Massachusetts general Hospital

Boston, Massachusetts, United States