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

University of Miami

Status: Begins enrollment this month

Conditions: Sarcoma

Treatments: Behavioral: Exit Interview; Behavioral: Usual Care Control; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07359911

20250858

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Exercise Intervention Group (EXE)

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention

Behavioral: Exit Interview

Usual Care Control Group (UC)

Other group

Description:

Participants in this group may opt to receive a weekly brief symptom self-assessment as a survey. Total participation duration is about 12 weeks.

Treatment:

Behavioral: Usual Care Control