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

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.

Study Overview

• Status: Recruiting
• Conditions: Tumor Surgery
• Intervention / Treatment: Other: Caloric Restriction Diet

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Santiago A Lozano-Calderón, MD, PhD; Phone Number: 617-643-4947; Email: slozanocalderon@mgh.harvard.edu
• Study Contact Backup: Name: Shreya Halur, BS; Phone Number: 617-726-4932; Email: shalur@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Santiago A Lozano-Calderón, MD, PhD; Phone Number: 617-643-4947; Email: slozanocalderon@mgh.harvard.edu
      • Principal Investigator: Santiago A Lozano-Calderón, MD,PhD
      • Contact: Shreya Halur, BS; Phone Number: 617-726-4932; Email: shalur@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal Diet; Participant will follow a normal diet.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In The Rate Of Physical Function By MSTS	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.	Baseline, 6 weeks, 3 months and 6 months visits after surgery
Change In The Rate Of Physical Function By TESS	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.	Baseline, 6 weeks, 3 months and 6 months visits after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
The Rate Of Wound Healing	2 years
The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: NORCH (Nutrition Obesity Research Center at Harvard)
• Investigators: Principal Investigator: Santiago A Lozano-Calderón, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimated): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Surgery
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Energy Intake; Caloric Restriction
• Other Study ID Numbers: 15-485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO