Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caloric Restriction Diet.
- Who it may be relevant to
- Registry conditions: Tumor Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
Overview
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
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.
Interventions
- Other Caloric 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.
Primary outcome measures
- Change In The Rate Of Physical Function By MSTS [Time frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery]
- Change In The Rate Of Physical Function By TESS [Time frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery]
Secondary outcome measures (2)
- The Rate Of Wound Healing [Time frame: 2 years]
- The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group [Time frame: 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts general Hospital — Boston
Identifiers
NCT: NCT02792270 · 15-485