Exercise and Soft Tissue Sarcoma

Официальное название

The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection

Обзор

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.

Вмешательства

• Другое neoadjuvant exercise therapy
  brief exercise regimen completed immediately prior to neoadjuvant radiation therapy. Rubber bands will be used for the exercise training of patients with lower extremity tumors while an electronic hand-held dynamometer will be used for the exercise training for patients with upper extremity tumors.

Первичные конечные точки

• Number of patients with a wound complication after surgery as measured by wound complication form [Срок оценки: Up to 24 weeks post-op]

Вторичные конечные точки (12)

• Percent necrosis of tumor [Срок оценки: During surgery]
• Number of inflammatory serum markers [Срок оценки: First day of NRT]
• Number of inflammatory serum markers [Срок оценки: Halfway through NRT (up to 5 weeks of NRT)]
• Number of inflammatory serum markers [Срок оценки: Last day of NRT (up to 10 weeks of NRT)]
• Tissue Perfusion [Срок оценки: 6-week post-op]
• The Musculoskeletal Tumor Society (MSTS) score [Срок оценки: At enrollment.]
• The Musculoskeletal Tumor Society (MSTS) score [Срок оценки: 2 weeks or less prior to surgery]
• The Musculoskeletal Tumor Society (MSTS) score [Срок оценки: 6-week post-op]
• Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire [Срок оценки: At enrollment]
• Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire [Срок оценки: 2 weeks or less prior to surgery]
• Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire [Срок оценки: 6-week post-op]
• Surgical Wound Assessment Form [Срок оценки: Up to 24 weeks post-op]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Duke University — Durham

Идентификаторы

NCT: NCT04921917 · Pro00093033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗