- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280885
A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy (FIERCE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emer Guinan, PhD
- Phone Number: +35318962126
- Email: guinane1@tcd.ie
Study Locations
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-
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Dublin, Ireland, 8
- St James's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged >18.
- Histological confirmed diagnosis of stage I to IIIc breast 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.
Exclusion Criteria:
- Advanced/metastatic disease.
- Scheduled to receive concurrent chemoradiotherapy.
- Scheduled to receive high-dose chemotherapy during hospital admission.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FIERCE Programme
The 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. |
Participants will be randomised to either the FIERCE exercise programme involving supervised exercise prescription
Participants in both arms will be provided with a pedometer as a health behaviour change intervention
|
Active Comparator: Pedometer programme
Participants 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.
|
Participants in both arms will be provided with a pedometer as a health behaviour change intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Recruitment rates
Time Frame: At enrolement
|
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.
|
At enrolement
|
Feasibility: Adherence rates
Time Frame: Through study completion, on average 6 months
|
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.
|
Through study completion, on average 6 months
|
Feasibility: Attendance rates
Time Frame: Through study completion, on average 6 months
|
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.
|
Through study completion, on average 6 months
|
Feasibility: Retention Rates
Time Frame: Through study completion, on average 6 months
|
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.
|
Through study completion, on average 6 months
|
Feasibility: Reason for drop0out
Time Frame: Through study completion, on average 6 months
|
Reasons for dropout will be recorded descriptively
|
Through study completion, on average 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiorespiratory Fitness
Time Frame: Pre and post intervention (on average 6 months)
|
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.
|
Pre and post intervention (on average 6 months)
|
Muscular Strength
Time Frame: Pre and Post intervention, on average 6 months
|
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. |
Pre and Post intervention, on average 6 months
|
Body Mass Index
Time Frame: Pre and Post intervention, on average 6 months
|
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)).
|
Pre and Post intervention, on average 6 months
|
Mid-arm circumference
Time Frame: Pre and Post intervention, on average 6 months
|
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.
|
Pre and Post intervention, on average 6 months
|
Waist Circumference
Time Frame: Pre and Post intervention, on average 6 months
|
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.
|
Pre and Post intervention, on average 6 months
|
Bioimpedance Analysis
Time Frame: Pre and Post intervention, on average 6 months
|
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).
|
Pre and Post intervention, on average 6 months
|
Health Related Quality of Life
Time Frame: Pre and Post intervention, on average 6 months
|
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.
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Pre and Post intervention, on average 6 months
|
Fatigue
Time Frame: Pre and Post intervention, on average 6 months
|
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.
|
Pre and Post intervention, on average 6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FIERCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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