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Prehabilitation for Soft Tissue Sarcoma

N/A

Recruiting

Led By Krista A Goulding

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2, 6, and 12 weeks

Awards & highlights

Study Summary

This trial will test whether patients who receive a tailored prehabilitation exercise regimen during radiotherapy have better surgical outcomes than those who do not.

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of deep soft tissue sarcoma in the lower extremity, who can consent to participate. It's not for those with metastatic disease, tumors in superficial locations relative to fascia, or involvement of both upper and lower limbs.Check my eligibility

What is being tested?

The study tests if a personalized exercise program (prehabilitation) during radiotherapy before surgery improves recovery and surgical outcomes for patients with soft tissue sarcomas compared to standard care without prehabilitation.See study design

What are the potential side effects?

While this trial focuses on exercise and education rather than drugs, potential side effects may include typical risks associated with physical therapy such as muscle soreness or strain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2, 6, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2, 6, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2, 6, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daily step count

Efficacy potential

Feasibility as measured by recruitment, retention, adherence, and acceptability

+3 more

Secondary outcome measures

Global health related quality of life

Symptom status

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (prehabilitation physical therapy)Experimental Treatment6 Interventions

Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.

Group II: Arm II (educational materials)Active Control5 Interventions

Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Physical Therapy

2020

Completed Phase 4

~1460

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,975 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,981 Total Patients Enrolled

Krista A GouldingPrincipal InvestigatorMayo Clinic

Media Library

Individualized Prehabilitation Exercise Regimen Clinical Trial Eligibility Overview. Trial Name: NCT05526417 — N/A

Soft Tissue Sarcoma Research Study Groups: Arm I (prehabilitation physical therapy), Arm II (educational materials)

Soft Tissue Sarcoma Clinical Trial 2023: Individualized Prehabilitation Exercise Regimen Highlights & Side Effects. Trial Name: NCT05526417 — N/A

Individualized Prehabilitation Exercise Regimen 2023 Treatment Timeline for Medical Study. Trial Name: NCT05526417 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being added to this clinical trial currently?

"Affirmative. Information from clinicaltrials.gov reveals that this study, initially posted on June 8th 2022, is actively recruiting patients. The trial requires 30 participants to be recruited from a single medical facility."

Answered by AI

How many participants can take part in this experiment?

"Indeed, the clinicaltrials.gov portal attests to this medical trial's active recruitment efforts. The original posting on 8th June 2022 has been recently amended as of 2nd September 2022; 30 patients are expected between 1 center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma

2022. "Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526417.

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