Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT (NCT02792270) | Clinical Trial Compass
RecruitingNot Applicable
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
United States32 participantsStarted 2016-06
Plain-language summary
This study is being conducted to decrease the rate of surgical wound complications. The investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change In The Rate Of Physical Function By MSTS
Timeframe: Baseline, 6 weeks, 3 months and 6 months visits after surgery
2
Change In The Rate Of Physical Function By TESS
Timeframe: Baseline, 6 weeks, 3 months and 6 months visits after surgery