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Caloric Restriction Diet for Sarcoma

N/A

Recruiting

Led By Santiago A Lozano-Calderón, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years

Biopsy proven soft tissue sarcoma located in the lower extremities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is exploring if reducing calories before surgery can reduce wound complications after surgery.

Who is the study for?

This trial is for adults over 18 with a confirmed soft tissue sarcoma in the lower extremities, who are not pregnant or breastfeeding, don't have diabetes or other cancers within the last 5 years, and aren't on metformin therapy. They must have normal organ function and blood counts, a BMI ≥ 20 kg/m2, and be scheduled for radiation followed by surgery.Check my eligibility

What is being tested?

The study tests if eating fewer calories can reduce surgical wound complications in sarcoma patients undergoing pre-operative radiation therapy. Participants will follow a caloric restriction diet before their tumor surgery to see if it helps improve outcomes.See study design

What are the potential side effects?

Potential side effects of the caloric restriction diet may include fatigue due to lower energy intake, possible nutritional deficiencies if not monitored properly, and potential exacerbation of any pre-existing conditions related to food intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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My biopsy confirmed I have soft tissue sarcoma in my legs.

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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change In The Rate Of Physical Function By MSTS

Change In The Rate Of Physical Function By TESS

Secondary outcome measures

The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group

The Rate Of Wound Healing

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Caloric Restriction DietExperimental Treatment1 Intervention

Patients will meet with the Registered Dietitian to discuss calorie, protein, and fluid needs.The dietitian will calculate calorie needs. Calorie needs will be reduced by 30%. Protein needs will be estimated based on 0.8g/kg BW and then reduced by 70%. Dietitian will educate participants on electrolytes and fluid intake based on the reduced food intake.

Group II: Normal DietActive Control1 Intervention

Participant will follow a normal diet.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,609 Total Patients Enrolled

NORCH (Nutrition Obesity Research Center at Harvard)UNKNOWN

1 Previous Clinical Trials

30 Total Patients Enrolled

Santiago A Lozano-Calderón, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment ongoing for this research endeavor?

"Absolutely. Evidently, the data on clinicaltrials.gov asserts that this study is currently accepting patients. This trial was first published on June 1st 2016 and has since been updated lastly November 2nd 2023. 32 participants are sought from a single medical centre for involvement in this investigation."

Answered by AI

How many participants may be accepted into this research study?

"Affirmative. Clinicaltrials.gov records indicate that this clinical trial is currently recruiting individuals; it was first posted on June 1st 2016 and last updated November 2nd 2023. 32 participants from one particular site are needed to fill the study's requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Santiago Lozano-Calderon 2016. "Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02792270.