This clinical trial studies how well a reduced calorie diet works in reducing wound complications in patients with soft tissue sarcomas undergoing surgery after radiation therapy. Patients who are treated with radiation therapy before surgery are at an increased risk of having wound complications after surgery. Giving patients a reduced calorie diet before surgery may reduce the rate of wound complications after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02792270.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Santiago Lozano-Calderon
Phone: 617-643-4947
PRIMARY OBJECTIVE:
I. To investigate the effects of short-term preoperative protein/caloric restriction (PCR) on postoperative wound complications in patients with lower extremity soft tissue sarcomas, who have undergone preoperative radiation therapy, compared to matched lower extremity soft tissue sarcoma patients on a regular diet.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (normal diet): Patients follow a normal diet before surgery.
GROUP II (PCR): Patients receive a PCR diet consisting of reduced calorie intake, reduced protein intake, and nutritional supplements from Ensure for 3 days prior to surgery.
After completion of the study, patients are followed up at 6 weeks, 3 months, and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorSantiago Lozano-Calderon