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Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

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Mass General Brigham

Status

Enrolling

Conditions

Tumor Surgery

Treatments

Other: Caloric Restriction Diet

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Caloric Restriction Diet
Experimental group
Description:
Patients will meet with the Registered Dietitian to discuss calorie, protein, and fluid needs.The dietitian will calculate calorie needs. * Calorie needs will be reduced by 30%. * Protein needs will be estimated based on 0.8g/kg BW and then reduced by 70%. * Dietitian will educate participants on electrolytes and fluid intake based on the reduced food intake.
Treatment:
Other: Caloric Restriction Diet
Normal Diet
No Intervention group
Description:
Participant will follow a normal diet.

Trial contacts and locations

1

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Central trial contact

Joseph J Connolly; Santiago A Lozano-Calderón, MD, PhD

Data sourced from clinicaltrials.gov

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