The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of patients with a wound complication after surgery as measured by wound complication form
研究概览
简要总结
The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is partially blinded. The wound surveyor and statistician(s) will be blinded to the treatment groups.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females within the ages of 18-85
- •Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
- •Sarcoma of the upper or lower extremity location
- •Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
- •Expected primary wound closure performed at the time at surgery
- •Any disease stage
- •Any tumor grade
- •Any histologic subtype
- •First or recurrent presentations
- •No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- •No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- •Must be able to comply with follow up visits
- •Must be able to provide own consent
排除标准
- •Patients under the age of 18, or over the age of 85
- •Treatment plan that does not include neo-adjuvant radiation and surgical excision
- •Sarcoma location other than the upper or lower extremity
- •History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- •High dose steroid therapy (defined as >5mg prednisone, or equivalent, with the last 30 days)
- •Active treatment with chemotherapy within the last 30 days
- •Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
- •Plan for post-operative radiation therapy
- •Underlying severe cardiopulmonary disease
- •Prior surgery, other than a biopsy, at the site of disease
- •Tumors that are ulcerative or fungating through the dermis at the time of presentation
- •Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- •Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion)
- •Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c>8)
- •Active deep vein thrombosis in the treatment extremity
- •Inability to comply with follow up visits
- •Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
研究组 & 干预措施
Control
Standard of care: neoadjuvant radiation therapy (NRT).
Neoadjuvant Exercise Regimen
Subjects will receive conventional NRT in conjunction with a prescribed exercise regimen during the usual 10-week duration of NRT treatment prior to tumor resection.
干预措施: neoadjuvant exercise therapy (Other)
结局指标
主要结局
Number of patients with a wound complication after surgery as measured by wound complication form
时间窗: Up to 24 weeks post-op
The wound complication form is a team developed form that asks about different complications that can arise after surgery. These complications include delayed wound healing, surgical site or periprosthetic infection, re-operation, and other invasive procedures necessitated by wound complications.
次要结局
- Number of inflammatory serum markers(Last day of NRT (up to 10 weeks of NRT))
- Tissue Perfusion(6-week post-op)
- The Musculoskeletal Tumor Society (MSTS) score(6-week post-op)
- Percent necrosis of tumor(During surgery)
- Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire(6-week post-op)
- Surgical Wound Assessment Form(Up to 24 weeks post-op)