Exercise and Soft Tissue Sarcoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04921917
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • neoadjuvant exercise therapy — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2021
Status verified
Apr 2026
Primary completion
Jan 1, 2030
Completion
Jan 1, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Standard of care: neoadjuvant radiation therapy (NRT).
  • Experimental: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710
William Eward, DVM, MD
[email protected]
919-613-5550

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Duke University· Durham, NC

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