Trial NCT02792270
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- Phase
- Not given
- Sponsor
- Massachusetts General Hospital
- Conditions
- Tumor Surgery
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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%Performance status
* Body Mass Index (BMI) ≥ 20 kg/m2BMI
* 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 feedingPregnancy
* Other cancers diagnosed within the last 5 years (in situ and/or invasive)Prior malignancy
* Diabetes mellitusDiabetes
* 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)
Restrictions found (5)
- BMIConditionalinclusion
BMI >= 20 kg/m2
Show in the text - DiabetesOutrightexclusionShow in the text
- Performance statusConditionalinclusion
Karnofsky >= 60%
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
within 5 years
Show in the text
Recruiting in Massachusetts
- Massachusetts general Hospital · Boston, Suffolk County