Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Purpose

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.

Condition

  • Tumor Surgery

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Caloric Restriction Diet 		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.
  • 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.
No Intervention
Normal Diet 		Participant will follow a normal diet.

Recruiting Locations

Massachusetts general Hospital
Boston, Massachusetts 02114
Contact:
Santiago A Lozano-Calderón, MD, PhD
617-643-4947
slozanocalderon@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Santiago A Lozano-Calderón, MD, PhD
617-643-4947
slozanocalderon@mgh.harvard.edu

Detailed 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.