Recruiting

Caloric Restriction

Sponsor:

Massachusetts General Hospital

Code:

NCT02792270

Conditions

Tumor Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caloric Restriction Diet

Study Details

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

Study ID

NCT02792270

Start date

Jun, 2016

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change In The Rate Of Physical Function By MSTS [ Time Frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery ]
  • Change In The Rate Of Physical Function By TESS [ Time Frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery ]

Central Contacts and Locations

Central contacts

Santiago A Lozano-Calderón, MD, PhD

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

Shreya Halur, BS

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

Locations

Massachusetts general Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Santiago A Lozano-Calderón, MD, PhD

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

Shreya Halur, BS

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

Principal Investigator:

Santiago A Lozano-Calderón, MD,PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-15.