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NCT Number: NCT07359911

Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients

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.

Recruiting

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Key information

Age range

12 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Gina D'Amato, MD

PRINCIPAL_INVESTIGATOR

Grey Freylersythe, BS

CONTACT

[email protected]

305-243-9832

Harleen Kaur, PhD

PRINCIPAL_INVESTIGATOR

Jonathan Trent, MD

PRINCIPAL_INVESTIGATOR

Loren Yavelberg, PhD

CONTACT

[email protected]

Loren Yavelberg, PhD

PRINCIPAL_INVESTIGATOR

Sara St. George, PhD

PRINCIPAL_INVESTIGATOR

Tracy E Crane, PhD, RDN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Sarcoma
  • Pediatric or AYA (12-39 years old)
  • Able to provide written informed consent
  • Able to speak, read, and understand English or Spanish
  • 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.
  • Approval from a medical oncology provider to participate.
  • 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
  • Having not consistently engaged in resistance training 2 or more days per week over the past 3 months

Exclusion criteria

  • < 12 or >39 years old
  • Unable to provide consent
  • Unable to read or understand English or Spanish
  • Oxygen-dependent
  • Unable to walk 2 blocks without assistance (excluding canes)
  • Unstable bone metastases
  • More than 90 days from initiation of first-line systemic therapy.
  • 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.

Treatment and study plan

Exercise Intervention

Behavioral

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.

Usual Care Control

Behavioral

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.

Exit Interview

Behavioral

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.

Primary outcomes

  1. Feasibility of Participant Engagement at Time of Consent

    Time frame: Baseline

    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.

  2. Feasibility of Participant Engagement at All Time Points

    Time frame: Up to 12 weeks

    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.

  3. Acceptability of Participants that Feel Satisfied with Exercise Intervention

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Change in Chemotherapy RDI (Relative Dose Intensity)

    Time frame: Baseline, 12 weeks

    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)).

Study contacts

Contact information is provided by the study sponsor or research team.

Grey Freylersythe, BS

CONTACT

[email protected]

305-243-9832

Loren Yavelberg, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

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

Acronym: ACTIVE-SARC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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