Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
Massachusetts General Hospital
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.
Description
The goal is to decrease the chance of having wound complications after surgery. Caloric Restriction has been found to be a natural modifier of surgical outcomes. Participants will be randomize into the arms Caloric Restriction Diet or Normal Diet.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 pregnanc…
Interventions
- OtherCaloric 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.
Location
- Massachusetts general HospitalBoston, Massachusetts