Tumor Surgery
Conditions
Keywords
Surgery
Brief summary
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
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In The Rate Of Physical Function By MSTS | Baseline, 6 weeks, 3 months and 6 months visits after surgery | 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. |
| Change In The Rate Of Physical Function By TESS | Baseline, 6 weeks, 3 months and 6 months visits after surgery | 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. |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactSantiago A Lozano-Calderón, MD, PhD
Backup ContactShreya Halur, BS
Outcome results
None listed