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NCT Number: NCT02792270

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Santiago A Lozano-Calderón, MD, PhD

CONTACT

[email protected]

617-643-4947

Santiago A Lozano-Calderón, MD,PhD

PRINCIPAL_INVESTIGATOR

Shreya Halur, BS

CONTACT

[email protected]

617-726-4932

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change In The Rate Of Physical Function By MSTS

    Time frame: 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.

  2. Change In The Rate Of Physical Function By TESS

    Time frame: 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 outcomes

  1. The Rate Of Wound Healing

    Time frame: 2 years

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

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Santiago A Lozano-Calderón, MD, PhD

CONTACT

[email protected]

617-643-4947

Shreya Halur, BS

CONTACT

[email protected]

617-726-4932

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Jun 7, 2016
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.