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AzTrials

CancerFIERCENCT06280885

A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

A study testing Exercise and Health Behaviour Change (Pedometer) in people with Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Exercise and Health Behaviour Change (Pedometer)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteIreland
Study dates
1 Jan 2025to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged >18.
  • Histological confirmed diagnosis of stage I to IIIc breast, ovarian or colorectal cancer.
  • Scheduled to receive chemotherapy ± immunotherapy with curative intent.
  • Medical clearance from oncologist to partake in regular exercise in accordance with American College of Sports Medicine (ACSM) preparticipation screening algorithm.
  • Ability to provide written informed consent.

Who cannot join

  • Advanced/metastatic disease.
  • Scheduled to receive concurrent chemoradiotherapy.
  • Scheduled to receive high-dose chemotherapy during hospital admission.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • St James's Hospital

    Dublin, Dublin, 8

Other trials in Ireland

About this study

The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment.

Read the detailed description

Exercise has been shown to play an important role in reducing many of the side effects associated with chemotherapy treatment. Exercise can help to improve symptoms of fatigue, nausea, muscle weakness, and pain, which in turn can help to improve patients overall quality of life and wellbeing. In addition to this, exercising during chemotherapy can also help to maintain physical fitness and preserve muscle mass, which has been shown to significantly reduce treatment toxicities. Despite these benefits of exercise, performing regular physical activity during chemotherapy poses significant challenges. Patients are faced with a number of physical and logistical barriers during chemotherapy which makes it difficult to engage in regular exercise. In addition to this, exercise programs that are being designed lack flexibility and individualization, and don't account for the unpredictable nature of chemotherapy treatment. It is, therefore, no surprise that patients struggle to meet the exercise recommendations during chemotherapy, and highlights the need for careful consideration when prescribing exercise during this time. In preparation for this study, the research team held a number of workshops which included a mixture of patients and healthcare professionals with the aim of co-designing an exercise intervention for patients during chemotherapy. Including public and patient involvement (PPI) in the design process will help to ensure that the exercise program that is developed is pragmatic and, most importantly, patient-centred.

Conditions
Cancer
Being tested
Exercise, Health Behaviour Change (Pedometer)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Participants will be randomised to either the FIERCE exercise programme involving supervised exercise prescription

  • Health Behaviour Change (Pedometer)Behavioural

    Participants in both arms will be provided with a pedometer as a health behaviour change intervention

Study groups in NCT06280885
Study groupRoleWhat they receive
FIERCE ProgrammeExperimentalThe FIERCE programme will consist of an aerobic and resistance exercise program delivered for the duration of chemotherapy. Exercise will be prescribed with the aim of achieving an overall exercise volume over the course of a chemotherapy cycle. The total volume of exercise prescribed in each cycle will be targeted towards achieving the exercise guidelines for cancer survivors which recommends 90 minutes of aerobic activity per week, in addition to resistance exercise at least two times per week. Exercise intensity will be autoregulated by participants based on how they are feeling on a given day. Participants will be given a choice of exercising at low, moderate, or higher intensity based on how BORG rating of perceived exertion (RPE) scale. Weekly check ins will be made to each participant over the phone by an exercise physiologist for goal setting. Participants will also be given a pedometer to monitor daily physical activity levels.
Receives: Behavioral: Exercise; Behavioral: Health Behaviour Change (Pedometer)
Pedometer programmeActive comparatorParticipants randomized to the pedometer programme will receive individualised advice about exercising during chemotherapy and will also receive a pedometer to encourage daily activity. Participant in both groups will receive a personal exercise consultation to identify their individual needs and understand their exercise preferences.
Receives: Behavioral: Health Behaviour Change (Pedometer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Recruitment rates

    Recruitment rates will be calculated as the percentage of eligible participants who agreed to take part in the study. Recruitment rates will be calculated for each recruitment timepoint to determine which timepoint yields optimal recruitment. Reasons for declining recruitment will also be recorded.

    Measured: At enrolement

  2. Feasibility: Adherence rates

    Exercise adherence will be used to measure the degree to which the participants performed the exercise at the desired intensity and time. After each exercise session, participants will be asked to rate their perceived exertion that they actually achieved during the exercise class. This RPE will be compared to the prespecified intensity that was chosen by the participant on the BORG scale at the beginning of the class to determine adherence to the intensity of the exercise session. Adherence to exercise time will be calculated by recording the total number of minutes spent exercising in each class compared to the total duration of the class.

    Measured: Through study completion, on average 6 months

  3. Feasibility: Attendance rates

    Exercise attendance will be calculated as the total number of exercise classes attended, either in-person or online, regardless of how much exercise was performed.

    Measured: Through study completion, on average 6 months

  4. Feasibility: Retention Rates

    Retention rates will be calculated as the number of participants who remained in the study at the end of the intervention as a proportion of the total number of participants recruited.

    Measured: Through study completion, on average 6 months

  5. Feasibility: Reason for drop0out

    Reasons for dropout will be recorded descriptively

    Measured: Through study completion, on average 6 months

Secondary outcomes (8)

  1. Cardiorespiratory Fitness

    Cardiorespiratory fitness will be estimated using the submaximal Astrand-Rhyming Cycle Ergometer Test (ARCET). The test will be performed on a cycle ergometer and will include breath-by-breath analysis using COSMED QUARK equipment.

    Measured: Pre and post intervention (on average 6 months)

  2. Muscular Strength

    Leg Strength Leg strength will be measured using a 1 repetition max (1RM) leg press test. Participants will complete a warm-up of 6 repetitions at approximately 60% 1RM followed by 3 repetitions at 80% 1RM. Following successful completion of the warm-up repetitions, participants will perform a maximum effort to determine their 1RM. Participants will be given a maximum of 5 attempts to determine their 1RM with a 2-minute rest between each attempt.

    Hand Grip Strength Hand grip strength (HGS) will be measured using a hand-held dynamometer. Participants will perform the test in a seated position, with their elbow at 90 degrees. Participants will be instructed to squeeze on the handle using maximum effort for 3 seconds. Three attempts will be made on each hand with a 1-minute rest between attempts. The highest value will be recorded.

    Measured: Pre and Post intervention, on average 6 months

  3. Body Mass Index

    Weight (kilogrammes (kg)) and height (centimetres (cm)) will be recorded by standard methods using a calibrated scales and stadiometer. Body mass index (BMI) will be calculated as weight (kg)/ height (metres (m2)).

    Measured: Pre and Post intervention, on average 6 months

  4. Mid-arm circumference

    Mid-arm muscle circumference will be measured in centimetres at the halfway point between the olecranon process of the ulna and the acromion process of the scapula.

    Measured: Pre and Post intervention, on average 6 months

  5. Waist Circumference

    Waist circumference will be measured in centimetres at the mid-point between the iliac crest and the 12th rib following gentle expiration. Circumferential measurements will be taken in duplicate and averaged for data entry.

    Measured: Pre and Post intervention, on average 6 months

  6. Bioimpedance Analysis

    Bioimpedance analysis (BIA) will be used to determine body composition and will be performed using the SECA mBCA 515 (Seca, Hamburg, Germany). Measures recorded will include; fat mass, fat free mass, and skeletal muscle mass (all measured in kg).

    Measured: Pre and Post intervention, on average 6 months

  7. Health Related Quality of Life

    Health-related quality of life will be determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 version 3.0). This validated instrument assessed quality of life in functional, symptom and global domains. Scores for each question were calculated according to the EORTC QLQ-C30 manual and linearly transformed into a 0-100 scale A high score for a functional scale indicates a high level of functioning. A high score for a symptom scale/single item represents a high symptom burden.

    Measured: Pre and Post intervention, on average 6 months

  8. Fatigue

    Fatigue will be measured using the Cancer Fatigue Scale (CFS). The CFS is a 15-item scale comprising of 3 subscales, physical (maximum score 28), affective (maximum score 16), and cognitive (maximum score 16), with a total score range from 0-60. Higher scores reveal more severe fatigue.

    Measured: Pre and Post intervention, on average 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Jan 2025
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility randomised controlled trial using a 2:1 randomisation
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280885
Sponsor's protocol ID
FIERCE
Acronym
FIERCE
Status last verified
Apr 2026
First submitted
6 Dec 2023
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kearney N, Connolly D, Bahramian K, Sheill G, Coghlan-Lynch K, O'Sullivan J, Coleman N, O'Hanlon Brown C, Gallagher D, O'Gorman C, O'Brien C, Tierney A, Rankin K, O'Neill L, Guinan E. A Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial. Contemp Clin Trials. 2025 Jun;153:107923. doi: 10.1016/j.cct.2025.107923. Epub 2025 Apr 21.

    PubMed 40268238

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Health Behaviour Change (Pedometer) in people with Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Recruitment rates (time frame: At enrolement). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06280885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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