Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02792270

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Led by Massachusetts General Hospital · Updated on 2025-10-06

32

Participants Needed

1

Research Sites

569 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Biopsy-proven soft tissue sarcoma located in the lower extremities
  • Planned treatment with radiation therapy for primary or recurrent lower extremity soft tissue sarcoma followed by surgical resection
  • Karnofsky Score of 60% or higher
  • Body Mass Index of 20 kg/m2 or higher
  • Protein levels within normal limits within 45 days before enrollment
  • Normal kidney and liver function within 45 days before enrollment
  • Normal blood counts within 45 days before enrollment
  • Normal chemistries within 45 days before enrollment
Not Eligible

You will not qualify if you...

  • Current pregnancy or breastfeeding
  • Diagnosis of other cancers within the last 5 years (in situ or invasive)
  • Diabetes mellitus
  • Current treatment with metformin
  • Any condition preventing surgery, such as intractable nausea, allergic reaction to supplements, decision not to have surgery, or other medical conditions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts general Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

S

Santiago A Lozano-Calderón, MD, PhD

CONTACT

S

Shreya Halur, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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