Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Recruiting now · Not applicable

Conditions studied: Tumor Surgery

In brief

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.

Key facts

Study ID

NCT02792270

Run by

Massachusetts General Hospital

People needed

32

Starts

2016-06-01

Expected to finish

2027-05-01

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Massachusetts general Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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