Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 1, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at how eating fewer calories might help lower the chances of complications after surgery for patients with certain types of tumors called soft tissue sarcomas, particularly those located in the lower legs. The goal is to see if reducing calorie intake before surgery, while the patient is receiving radiation therapy, can help improve healing and reduce issues like infections or delayed recovery after the operation.

To participate in this study, you need to be at least 18 years old and have been diagnosed with a soft tissue sarcoma in your lower extremities. You should be scheduled to receive radiation therapy followed by surgery to remove the tumor. Other requirements include having a good overall health status, measured by a score called the Karnofsky Score, and a normal body weight. However, this study is not for everyone; for instance, if you are pregnant, have diabetes, or have been diagnosed with another cancer recently, you may not be eligible. If you decide to join the trial, you can expect to follow a specific diet plan that limits calories as part of your treatment process.

Gender

ALL

Eligibility 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)