Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Not Applicable

Recruiting

• Conditions: Tumor Surgery
• Interventions: Other: Caloric Restriction Diet

• Registration Number: NCT02792270
• Lead Sponsor: Massachusetts General Hospital

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.

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.

Study Timeline

• Study First Submitted: 2016-05-16
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caloric Restriction Diet	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.

Primary Outcome Measures

Name	Time	Method
Change In The Rate Of Physical Function By MSTS	Baseline, 6 weeks, 3 months and 6 months visits after surgery	The Musculoskeletal Tumor Society Rating Scale (MSTS) is a clinician-based scoring system that is scored out of 35 points. A higher score indicates better physical function.
Change In The Rate Of Physical Function By TESS	Baseline, 6 weeks, 3 months and 6 months visits after surgery	The Toronto Extremity Salvage Score (TESS) is a patient-reported scoring system that is scored out of 100 points. A higher score indicates better physical function.

Secondary Outcome Measures

Name	Time	Method
The Rate Of Wound Healing	2 years
The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group	2 years

Trial Locations

Locations (1)

Massachusetts general Hospital; 🇺🇸 Boston, Massachusetts, United States