Pre-infusion Aerobic Cycling Exercise for CardioRespiratory Fitness in Cancer Patients

NCT ID: NCT07182773

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-09-30

Brief Summary

Background to this Research Patients who undergo cancer treatment involving chemotherapy or immunotherapy, can experience considerable reductions in their fitness levels. This is a concern, as exercise is a really important part of cancer care. Therefore delivering exercise programmes that support patients during their chemotherapy or immunotherapy treatment will be essential to helping people to maintain their fitness levels. Research is needed to examine the best way to introduce exercise into the patient pathway in a way that is convenient and patient-centred.

The Specific Questions Being Asked This research project aims to examine the effect of an exercise programme which involves exercising on the cancer treatment day ward with a physiotherapist while waiting for treatment infusion as a safe and effective way of supporting patients to keep fit and active during chemotherapy treatment. The trial will also investigate if it the prescribed moderate intensity exercise for 30 minutes is manageable for patients.

Trial Plan This project will be delivered as a randomised controlled trial. All participants enrolled on the trial will receive information and advice about physical activity during chemotherapy treatment from a physiotherapist with expertise in cancer care. The intervention arm will also complete an exercise session with the physiotherapist on the day of their infusion treatment over a period of 12 weeks.

The feasibility of this protocol has already been tested in 17 participants with very positive results. The information gained from this initial study will be used to deliver this trial, which will recruit 80 participants. It is hoped that the information gained from this research will provide a practical way of providing supervised exercise training for patients during chemotherapy or immunotherapy that is safe, expert-led and patient centred.

Detailed Description

Introduction

Cardiorespiratory fitness (CRF) is a critical health indicator that plays a significant role in predicting cancer risk and mortality. Notably, CRF often declines during infusion therapies such as chemotherapy and immunotherapy, and these declines may persist even after treatment completion. This reduction in CRF is concerning, as it may predispose patients to increased morbidity and mortality, especially given the cardiotoxic effects associated with some cancer treatments. Despite the importance of maintaining or improving CRF, the optimal timing and prescription for aerobic exercise in cancer care remain unclear. Current guidelines recommend that individuals with cancer aim for 150 minutes of moderate-intensity aerobic exercise weekly, or 75 minutes of vigorous-intensity exercise, along with twice-weekly resistance training. However, the prolonged periods of inactivity associated with infusion therapies, which often last several months, complicate adherence to these recommendations.

Aerobic exercise during cancer treatment has been shown to improve CRF, with systematic reviews indicating significant benefits in terms of physical function, fatigue reduction, and overall quality of life. Furthermore, exercise has been linked to improved cancer outcomes, including a reduced risk of cancer recurrence, lower cancer-specific mortality, and a decreased risk of all-cause mortality. Despite these benefits, adherence to exercise guidelines during cancer treatment remains low, with reports ranging from 8.5% to 34%. Barriers such as treatment side effects, fatigue, lack of knowledge, and time constraints often hinder patients from engaging in regular physical activity.

Recent studies suggest that supervised exercise performed immediately prior to infusion therapy may help mitigate these barriers, offering a structured and safe approach that could fit into patients' demanding treatment schedules. Additionally, there is emerging evidence that exercise performed during chemotherapy infusion could have beneficial physiological effects, such as improved tumour perfusion and enhanced drug delivery, potentially boosting the effectiveness of treatment. However, more research is needed to determine the optimal timing, duration, and intensity of exercise to achieve clinically meaningful benefits in this context.

As cancer incidence continues to rise, with approximately 44,000 new cancer cases reported annually in Ireland alone, the need for effective interventions that support patients during treatment is increasingly urgent. While exercise has demonstrated a range of physical, psychological, and immunological benefits, further investigation into the feasibility and impact of exercise during infusion therapy is essential to guide clinical practice. This protocol aims to address common barriers to exercise for cancer patients, based on recent systematic reviews and patient input, with the goal of enhancing patient care and outcomes through improved maintenance of CRF during treatment.

Aims and Objectives

The overall aim of this study is to examine the feasibility of delivering a supervised moderate intensity aerobic exercise intervention to patients with cancer directly before their infusion therapy.

The specific objectives are:

To determine the rate of recruitment of cancer patients willing to participate in the exercise programme during chemotherapy.

To examine the feasibility of intervention delivery, including exercise adherence, fidelity, and retention rates.

To examine if supervised moderate intensity aerobic exercise directly before infusion therapy increases and or maintains cardiorespiratory fitness in cancer patients to a greater extent than education alone.

To test the appropriateness of outcome assessments, data collection techniques, and suitability of proposed outcomes.

To monitor and record any adverse events to test the safety of the exercise intervention.

To gather feedback from patients regarding the acceptability of the exercise programme.

To examine the preliminary efficacy of the exercise programme on secondary endpoints such as fatigue, physical activity levels and quality of life.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise Arm

The exercise programme will be prescribed at a moderate intensity (Target Heart rate: 60%-65% Heart Rate Reserve + resting heart rate) for 30 minutes immediately prior to infusion therapy, on their treatment days over 12- weeks. Exercise will be completed on a stationary cycle ergometer. Target heart rate will be adjusted to 50-55% Heart Rate Reserve + resting heart rate if patient is complaining of fatigue/nausea, is on beta-blockers or if haemoglobin \<9g/dL. Heart rate monitoring by chest strap using the polar heart rate monitor will allow participants to self-regulate their exercise intensity. Participants should discontinue exercise and await medical review if they develop chest pain, dizziness or pre-syncope, cyanosis or pallor appearance, new musculoskeletal pain.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The exercise programme will be prescribed at a moderate intensity (Target Heart rate: 60%-65% Heart Rate Reserve + resting heart rate) for 30 minutes immediately prior to infusion therapy, on their treatment days over 12- weeks. Exercise will be completed on a stationary cycle ergometer. Target heart rate will be adjusted to 50-55% Heart Rate Reserve + resting heart rate if patient is complaining of fatigue/nausea, is on beta-blockers or if haemoglobin \<9g/dL. Heart rate monitoring by chest strap using the polar heart rate monitor will allow participants to self-regulate their exercise intensity. Participants should discontinue exercise and await medical review if they develop chest pain, dizziness or pre-syncope, cyanosis or pallor appearance, new musculoskeletal pain.

Education only

The control group will receive education on the physical activity recommendations during cancer treatment as per standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

The exercise programme will be prescribed at a moderate intensity (Target Heart rate: 60%-65% Heart Rate Reserve + resting heart rate) for 30 minutes immediately prior to infusion therapy, on their treatment days over 12- weeks. Exercise will be completed on a stationary cycle ergometer. Target heart rate will be adjusted to 50-55% Heart Rate Reserve + resting heart rate if patient is complaining of fatigue/nausea, is on beta-blockers or if haemoglobin \<9g/dL. Heart rate monitoring by chest strap using the polar heart rate monitor will allow participants to self-regulate their exercise intensity. Participants should discontinue exercise and await medical review if they develop chest pain, dizziness or pre-syncope, cyanosis or pallor appearance, new musculoskeletal pain.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged >18.

Histological confirmed diagnosis of stage I to IIIc breast, ovarian, or colorectal cancer.

Scheduled to receive chemotherapy ± immunotherapy with curative intent over at least a 12-week period.

Medical clearance from oncologist to partake in regular exercise in accordance with ACSM preparticipation screening algorithm.

Able to use exercise bike independently.

Ability to provide written informed consent.

Exclusion Criteria

• Advanced/metastatic disease.

Scheduled to receive concurrent chemoradiotherapy.

New pain or other pain that would preclude ability to use bike.

Inability to read and understand English.

Deemed unfit to proceed from results of CPET.

Unstable angina, arrhythmia, hypertension or decompensated heart failure.

Dementia or psychiatric illness which would preclude safe independent exercise.

Acute untreated embolus/infarct.

Dissecting aneurysm.

Acute myocarditis or pericarditis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Emer Guinan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Aoife McGovern

Role: CONTACT

physiotherapy@beaconhospital.ie

+3531 293 6692

References

Kearney N, Connolly D, Begic S, Mockler D, Guinan E. Feasibility metrics of exercise interventions during chemotherapy: A systematic review. Crit Rev Oncol Hematol. 2024 Mar;195:104272. doi: 10.1016/j.critrevonc.2024.104272. Epub 2024 Jan 23.

Reference Type: BACKGROUND

PMID: 38272152 (View on PubMed)

Other Identifiers

AHP24MCG

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TRI CRF 24-02

Identifier Type: -

Identifier Source: org_study_id