Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

NCT02792270 | Recruiting DMC

• 1 other identifier: 15-485
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor Surgery

Keywords

Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The Rate Of Wound Healing

  2 years

• The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group

  2 years

Study Arms (2)

Caloric Restriction Diet

EXPERIMENTAL

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

Normal Diet

NO INTERVENTION

Participant will follow a normal diet.

Interventions

Caloric Restriction Diet OTHER

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.

Caloric Restriction Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Santiago A Lozano-Calderón, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago A Lozano-Calderón, MD, PhD

CONTACT

617-643-4947; slozanocalderon@mgh.harvard.edu

Shreya Halur, BS

CONTACT

617-726-4932; shalur@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: June 7, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)