Massachusetts general Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Location contact
Santiago A Lozano-Calderón, MD, PhD
CONTACT
Santiago A Lozano-Calderón, MD,PhD
PRINCIPAL_INVESTIGATOR
Shreya Halur, BS
CONTACT
NCT Number: NCT02792270
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Santiago A Lozano-Calderón, MD, PhD
CONTACT
Santiago A Lozano-Calderón, MD,PhD
PRINCIPAL_INVESTIGATOR
Shreya Halur, BS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Time frame: 2 years
Contact information is provided by the study sponsor or research team.
Santiago A Lozano-Calderón, MD, PhD
CONTACT
Shreya Halur, BS
CONTACT
Massachusetts General Hospital
Other
Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.