RECRUITING

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-06

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02792270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Santiago A Lozano-Calderón, MD, PhD

CONTACT

617-643-4947

slozanocalderon@mgh.harvard.edu

Joseph J Connolly

CONTACT

617-643-3513

jconnolly28@mgh.harvard.edu

Principal Investigator

Santiago A Lozano-Calderón, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts general Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Santiago A Lozano-Calderón, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-06

Study Completion Date2027-05

Study Record Updates

Study Start Date2016-06

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

Surgery

Additional Relevant MeSH Terms

Tumor Surgery