Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tumor Surgery

Intervention / Treatment
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* Other: Caloric Restriction Diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caloric Restriction Diet<br>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. | Other: Caloric Restriction Diet<br>* Two nutritional supplements from Ensure (Abbott Laboratories, Chicago, IL) 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.<br>|
| No Intervention: Normal Diet<br>Participant will follow a normal diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change In The Rate Of Physical Function By MSTS | The Musculoskeletal Tumor Society Rating Scale (MSTS) is a clinician-based scoring system that is scored out of 35 points. A higher score indicates better physical function. | Baseline, 6 weeks, 3 months and 6 months visits after surgery | 
| Change In The Rate Of Physical Function By TESS | The Toronto Extremity Salvage Score (TESS) is a patient-reported scoring system that is scored out of 100 points. A higher score indicates better physical function. | Baseline, 6 weeks, 3 months and 6 months visits after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate Of Wound Healing |  | 2 years | 
| The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery