Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change In The Rate Of Physical Function By MSTS
研究概览
简要总结
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.
详细描述
The goal is to decrease the chance of having wound complications after surgery. Caloric Restriction has been found to be a natural modifier of surgical outcomes. Participants will be randomize into the arms Caloric Restriction Diet or Normal Diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Normal Diet
Participant will follow a normal diet.
Caloric Restriction Diet
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.
干预措施: Caloric Restriction Diet (Other)
结局指标
主要结局
Change In The Rate Of Physical Function By MSTS
时间窗: Baseline, 6 weeks, 3 months and 6 months visits after surgery
The Musculoskeletal Tumor Society Rating Scale (MSTS) is a clinician-based scoring system that is scored out of 35 points. A higher score indicates better physical function.
Change In The Rate Of Physical Function By TESS
时间窗: Baseline, 6 weeks, 3 months and 6 months visits after surgery
The Toronto Extremity Salvage Score (TESS) is a patient-reported scoring system that is scored out of 100 points. A higher score indicates better physical function.
次要结局
- The Rate Of Wound Healing(2 years)
- The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group(2 years)
研究者
Santiago Lozano-Calderon
Physician
Massachusetts General Hospital