Caloric restriction to reduce surgical complications in sarcoma patients
Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
This study tests whether eating fewer calories before surgery can help people with soft tissue sarcoma have fewer complications after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02792270 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of caloric restriction on reducing surgical wound complications in patients with soft tissue sarcoma. Participants will be randomly assigned to either a caloric restriction diet or a normal diet prior to undergoing surgery following radiation therapy. The aim is to determine if caloric restriction can improve surgical outcomes by minimizing complications. The study focuses on patients with biopsy-proven sarcoma in the lower extremities who meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with biopsy-proven soft tissue sarcoma in the lower extremities who are scheduled for surgery after radiation therapy.
Not a fit: Patients with diabetes, other cancers, or those currently on metformin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of surgical complications for sarcoma patients, leading to better recovery outcomes.
How similar studies have performed: While caloric restriction has been studied in various contexts, this specific application in sarcoma patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- Massachusetts general Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Santiago A Lozano-Calderón, MD, PhD — Massachusetts General Hospital
- Study coordinator: Santiago A Lozano-Calderón, MD, PhD
- Email: slozanocalderon@mgh.harvard.edu
- Phone: 617-643-4947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.