Sarcoma
Conditions
Keywords
exercise, chemotherapy, feasibility, adverse events, tumor perfusion
Brief summary
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.
Interventions
OTHERExercise
See description of study arm
Sponsors
Kira Bloomquist
Danish Cancer Society
Center for Physical Activity Research (CFAS)
Department of Nuclear Medicine, Herlev Hospital
Department of Oncology, Herlev Hospital
Copenhagen Research Center for Cancer Rehabilitation (CORE-Cancer), Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The intervention group will be compared to a historical control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initiating at least two series of chemotherapy for non-resected sarcoma at Clinic 6, Herlev Hospital, Denmark * Eastern Cooperative Oncology Group performance status of 0-2 * No mental or physical disabilities precluding exercise * Approval by the treating oncologist * Able to read Danish * Willing to sign informed consent
Exclusion criteria
* Home-based chemotherapy * Infusions lasting under one hour * Elevated risk for developing cardiac issues (left ventricular ejection fraction ≤50%) based on routine echocardiography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. | Adverse events will be extracted from medical records (including adjustment to treatment plans, adjunct medications or procedures) and categorized according to the Common Terminology Criteria for Adverse Events, version 5.0. In addition, before and after each infusion, the intra-infusion exercise group will be asked whether they have experienced any harmful or undesirable outcomes, with additional prompts to better understand the severity and impact of such events. Specific adverse events: Cardiac function and skeletal muscle damage: Routine echocardiography data will be extracted from medical records in both groups. Further, serum troponin I levels (a biomarker used in the early detection of cardiotoxicity) and serum creatine kinase (a biomarker routinely used to assess skeletal muscle damage) will be taken in conjunction with routine blood work in the exercise group. |
| Feasibility: recruitment rate | From initiation of participant recruitment in the department until recruitment of last participant. Anticipated within one year. | Feasibility of intra-infusion exercise will be assessed by analyzing the number accepting participation in intra-infusion exercise vs. number eligible |
| Feasibility: retention rate | From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months). | Feasibility of intra-infusion exercise will be asessed by analyzing the number of participants who remained in the study vs. number enrolled. |
| Feasibility: attendance rate | From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months). | Feasibility of intra-infusion exercise be assessed by analyzing the number of intra-infusion exercise sessions completed vs. number possible. |
| Feasibility: Adherence exercise intensity | From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months). | Feasibility of intra-infusion exercise will be assessed by analyzing the number of exercise sessions meeting exercise intensity target vs. number of exercise sessions possible. |
Countries
Denmark
Contacts
CONTACTKira Bloomquist, Physical therapist, MHS, PhD
CONTACTAnders Vinther, Physical therapist, PhD
PRINCIPAL_INVESTIGATORKira Bloomquist, Physical therapist, MHS, PhD
Center for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed