Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Conditions

• Tumor Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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 Dates

Start date

Jun 30, 2016

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

May 31, 2027

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Caloric Restriction Diet
  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.
• No Intervention: Normal Diet
  Participant will follow a normal diet.

Primary Outcome Measure

Change In The Rate Of Physical Function By MSTS [ Time Frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery ]

Central Contacts

• Santiago A Lozano-Calderón, MD, PhD
  617-643-4947
  [email protected]
• Shreya Halur, BS
  617-726-4932
  [email protected]

Locations (1)

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