Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Tumor Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02792270
• Other study ID #: 15-485
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2027

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: Santiago A Lozano-Calderón, MD, PhD
• Phone: 617-643-4947
• Email: slozanocalderon[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sarcoma
• Tumor Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts general Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The Rate Of Wound Healing		2 years
Secondary	The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group		2 years