Exercise and Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921917
• Other study ID #: Pro00093033
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: January 1, 2030

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: Elizabeth Sachs, MS
• Phone: 919-660-9849
• Email: elizabeth.sachs[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Males and females within the ages of 18-85

2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist

3. Sarcoma of the upper or lower extremity location

4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection

5. Expected primary wound closure performed at the time at surgery

6. Any disease stage

7. Any tumor grade

8. Any histologic subtype

9. First or recurrent presentations

10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity

11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied

12. Must be able to comply with follow up visits

13. Must be able to provide own consent

Exclusion Criteria:

1. Patients under the age of 18, or over the age of 85

2. Treatment plan that does not include neo-adjuvant radiation and surgical excision

3. Sarcoma location other than the upper or lower extremity

4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied

5. High dose steroid therapy (defined as >5mg prednisone, or equivalent, with the last 30 days)

6. Active treatment with chemotherapy within the last 30 days

7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)

8. Plan for post-operative radiation therapy

9. Underlying severe cardiopulmonary disease

10. Prior surgery, other than a biopsy, at the site of disease

11. Tumors that are ulcerative or fungating through the dermis at the time of presentation

12. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity

13. 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)

14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c>8)

15. Active deep vein thrombosis in the treatment extremity

16. Inability to comply with follow up visits

17. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a wound complication after surgery as measured by wound complication form	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.	Up to 24 weeks post-op
Secondary	Percent necrosis of tumor	Percent necrosis at the time of tumor resection	During surgery
Secondary	Number of inflammatory serum markers	Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.	First day of NRT
Secondary	Number of inflammatory serum markers	Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.	Halfway through NRT (up to 5 weeks of NRT)
Secondary	Number of inflammatory serum markers	Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.	Last day of NRT (up to 10 weeks of NRT)
Secondary	Tissue Perfusion	Tissue Perfusion using the Near Infra-Red (NIRS) system	6-week post-op
Secondary	The Musculoskeletal Tumor Society (MSTS) score	The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.	At enrollment.
Secondary	The Musculoskeletal Tumor Society (MSTS) score	The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.	2 weeks or less prior to surgery
Secondary	The Musculoskeletal Tumor Society (MSTS) score	The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.	6-week post-op
Secondary	Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire	The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.	At enrollment
Secondary	Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire	The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.	2 weeks or less prior to surgery
Secondary	Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire	The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.	6-week post-op
Secondary	Surgical Wound Assessment Form	Wound assessment and healing tracker tool created by the study team. The total score ranges from 13 to 65, with lower scores indicating better wound healing.	Up to 24 weeks post-op