Sarcoma and Intra-infusion Exercise for Better Outcomes

Sponsor
Kira Bloomquist
Study ID
NCT07785882
Status
Not Yet Recruiting

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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise — OTHER
    See description of study arm

Study Details

The main goal of this clinical trial is to determine: 1) the safety and 2) feasibility of moderate-intensity, intra-infusion aerobic exercise in people receiving chemotherapy for non-resected sarcoma and 3) assess whether intra-infusion exercise acutely increases tumor perfusion. The trial aims to answer the following research questions: * Is intra-infusion aerobic exercise safe in people receiving chemotherapy for sarcoma? * Is intra-infusion aerobic exercise feasible in people receiving chemotherapy for sarcoma? * Does aerobic exercise induce acute increases in tumor perfusion? * In future work, which patient reported outcomes are relevant to explore in people receiving chemotherapy for sarcoma? Adverse event data and patient-reported quality-of-life outcomes will be compared to those of a historical control comprising patients who received chemotherapy for sarcoma within three years prior to study initiation. Participants will: * Participate in light- to moderate-intensity aerobic exercise during chemotherapy infusion (intra-infusion exercise) for the duration of their treatment protocol. * Exercise will follow a 15-minute exercise / 15-minute rest interval, totaling 30 minutes of exercise per hour of infusion. * Prior to initiating chemotherapy, undergo a single 15-minute exercise session. During peak exercise, a radioactive tracer will be injected intravenously followed by a single-photon emission computed tomography and computed tomography (SPECT /CT) scan to obtain images of tumor perfusion. A resting SPECT/CT scan will also be performed.

Key Dates

First listed
Aug 25, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intra-infusion exercise
    The first cycle of chemotherapy will be delivered as per usual care. During all subsequent cycles, participants will partake in intra-infusion aerobic exercise (e.g. pedal ergometer, stationary bike). Exercise will follow a 15-minute exercise / 15-minute rest interval, totalling 30 minutes of exercise per hour of infusion. Participants will be monitored using the Borg rate of perceived exertion (RPE) scale (range 6-20) and heart rate monitors. Target intensity will be low (Borg RPE 10-12) for the first five minutes, increasing to moderate intensity (Borg RPE 13-15) for the last ten minutes. As a precautionary measure, only low-intensity exercise will be performed when receiving cytostatic agents known to carry an increased risk of cardiotoxicity (e.g. anthracyclines). Exercise will be supervised by a physical therapist with experience in exercise oncology, alongside oncology nurses as per usual care.

Primary Outcome Measure

Adverse events [ Time Frame: From the commencement of chemotherapy and up to six months post-chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants. ]

Central Contacts

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