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
Arm | Description | Assigned 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. |
|
No Intervention Normal Diet |
Participant will follow a normal diet. |
|
Recruiting Locations
Massachusetts general Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.