Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)

Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)

The purpose of this study is to determine the effects of a multimodal exercise intervention on chemotherapy uptake in newly diagnosed pediatric, adolescent and young adult (AYA) Sarcoma patients.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Behavioral: Exercise Intervention; Behavioral: Exit Interview; Behavioral: Usual Care Control

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grey Freylersythe, BS; Phone Number: 305-243-9832; Email: g.freylersythe@med.miami.edu
• Study Contact Backup: Name: Loren Yavelberg, PhD; Email: l.yavelberg@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Gina D'Amato, MD
      • Principal Investigator: Jonathan Trent, MD
      • Principal Investigator: Tracy E Crane, PhD, RDN
      • Contact: Grey Freylersythe, BS; Phone Number: 305-243-9832; Email: g.freylersythe@med.miami.edu
      • Contact: Loren Yavelberg, PhD; Email: l.yavelberg@med.miami.edu
      • Principal Investigator: Sara St. George, PhD
      • Principal Investigator: Harleen Kaur, PhD
      • Principal Investigator: Loren Yavelberg, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of Sarcoma
2. Pediatric or AYA (12-39 years old)
3. Able to provide written informed consent
4. Able to speak, read, and understand English or Spanish
5. Initiating first-line systemic therapy (Doxorubicin, Ifosfamide, Gemcitabine, Docetaxel, Trabectedin, Vincristine, Irinotecan, Temozolomide, Topotecan, Etoposide, Dacarbazine, Pazopanib, Tazemetostat, Imatinib, Sunitinib, Pembrolizumab, Nivolumab, Ipilumumab, Regorafenib, Atezulimumab). Participants can be enrolled up to 90 days after starting firstline systemic therapy.
6. Approval from a medical oncology provider to participate.
7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months

Exclusion Criteria:

1. < 12 or >39 years old
2. Unable to provide consent
3. Unable to read or understand English or Spanish
4. Oxygen-dependent
5. Unable to walk 2 blocks without assistance (excluding canes)
6. Unstable bone metastases
7. More than 90 days from initiation of first-line systemic therapy.
8. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention, as determined by the patient's provider and study clinician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention Group (EXE); Participants in this group will undergo supervised multimodal (aerobic, resistance, balance) moderate-to-vigorous exercise intervention three 3 times per week for 12 weeks, a total of 36 sessions. Total participation duration is about 12 weeks.	Behavioral: Exercise Intervention; Each session will include a brief conversation and standardized symptom assessment, followed by a warm-up including stretching & balance exercises, then a series of resistance exercises, ending with light-moderate intensity aerobic exercise (walking), with a target goal of 45-60 minutes total per session as tolerated by the patient.; Behavioral: Exit Interview; A semi-structured interview will be administered at 12 weeks to the intervention (EXE) group only to explore self-determination and efficacy, as well as intervention acceptability.
Other: Usual Care Control Group (UC); Participants in this group may opt to receive a weekly brief symptom self-assessment as a survey. Total participation duration is about 12 weeks.	Behavioral: Usual Care Control; A weekly brief symptom self-assessment as a survey will be delivered by Redcap survey, in person or remotely, or by telephone with researcher assistance. Completion of the survey will take approximately 10 minutes per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Participant Engagement at Time of Consent	Feasibility will be measured as the percentage of participants that consent and meet eligibility to participate between both the intervention and control arms. Criterion for success: At least (≥) 50% of all eligible participants consent to participate between both arms.	Baseline
Feasibility of Participant Engagement at All Time Points	Feasibility will be measured as the percentage of participants that adhere to and complete the arm-specific intervention and data collection at all time points between both the intervention and control arms. Criterion for success: Greater than (>) 70% of all eligible participants between both arms complete all scheduled assessments.	Up to 12 weeks
Acceptability of Participants that Feel Satisfied with Exercise Intervention	Acceptability will be measured as the percentage of participants that report satisfaction with the exercise intervention. Criterion for success: Greater than (>) 80% of all eligible participants complete the exercise intervention.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chemotherapy RDI (Relative Dose Intensity)	Change in chemotherapy relative dose intensity (RDI) at 12 weeks compared to baseline will be reported between both the intervention and control arms. RDI is the ratio of actual dose intensity to projected dose intensity, as a percentage or proportion of the amount of drug planned to deliver per weeks (mg/(m^2 x week)).	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Tracy E Crane, PhD, RDN, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): August 5, 2027

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Pediatric; Young Adult
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: 20250858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No