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Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Tumor Surgery

NCT02792270

Massachusetts General Hospital

29 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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