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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

Must not have

Other cancers diagnosed within the last 5 years (in situ and/or invasive)

Diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 3 months and 6 months visits after surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with any other cancer in the last 5 years.

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I have diabetes.

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I am currently taking metformin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3 months and 6 months visits after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 3 months and 6 months visits after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months and 6 months visits after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change In The Rate Of Physical Function By MSTS

Change In The Rate Of Physical Function By TESS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met