Sarcoma and Intra-infusion Exercise for Better Outcomes

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.

Conditions

• Sarcoma

Interventions

OTHER

Exercise

See description of study arm

Sponsors & Collaborators

• Danish Cancer Society

  collaborator OTHER

• Center for Physical Activity Research (CFAS)

  collaborator UNKNOWN

• Department of Nuclear Medicine, Herlev Hospital

  collaborator UNKNOWN

• Department of Oncology, Herlev Hospital

  collaborator UNKNOWN

• Copenhagen Research Center for Cancer Rehabilitation (CORE-Cancer), Herlev Hospital

  collaborator UNKNOWN

• Kira Bloomquist

  lead OTHER

Principal Investigators

• Kira Bloomquist, Physical therapist, MHS, PhD · Center for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2028-10-31

Completion

2028-10-31

Countries

• Denmark