RecruitingNot ApplicableNCT02792270

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

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


Sponsor

Massachusetts General Hospital

Enrollment

32 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether following a reduced-calorie diet during radiation therapy can improve treatment outcomes and reduce side effects for people with soft tissue sarcoma (cancer of muscle, fat, or connective tissue) in the leg. **You may be eligible if...** - You are over 18 years old - You have a biopsy-confirmed soft tissue sarcoma in the lower limb - You are scheduled to receive radiation therapy before surgery, or for a recurring tumor, followed by surgical removal - Your general fitness is adequate (Karnofsky score of 60% or higher) - Your BMI is 20 or above - Your blood protein levels, kidney and liver function, and blood counts are all within normal range **You may NOT be eligible if...** - You are currently pregnant or breastfeeding - You have been diagnosed with another cancer within the past 5 years - You have diabetes - You currently take metformin - You have other health conditions that would interfere with a calorie-restricted diet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCaloric 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.


Locations(1)

Massachusetts general Hospital

Boston, Massachusetts, United States

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NCT02792270