A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

Cancer Clinical Trial

— FIERCE  

Official title:

A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280885
• Other study ID #: FIERCE
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: University of Dublin, Trinity College
• Contact: Emer Guinan, PhD
• Phone: +35318962126
• Email: guinane1[@]tcd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Exercise
Participants will be randomised to either the FIERCE exercise programme involving supervised exercise prescription
• Health Behaviour Change (Pedometer)
Participants in both arms will be provided with a pedometer as a health behaviour change intervention

Locations

Country	Name	City	State
Ireland	St James's Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At enrolement
Primary	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.	Through study completion, on average 6 months
Primary	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.	Through study completion, on average 6 months
Primary	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.	Through study completion, on average 6 months
Primary	Feasibility: Reason for drop0out	Reasons for dropout will be recorded descriptively	Through study completion, on average 6 months
Secondary	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.	Pre and post intervention (on average 6 months)
Secondary	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.	Pre and Post intervention, on average 6 months
Secondary	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)).	Pre and Post intervention, on average 6 months
Secondary	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.	Pre and Post intervention, on average 6 months
Secondary	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.	Pre and Post intervention, on average 6 months
Secondary	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).	Pre and Post intervention, on average 6 months
Secondary	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.	Pre and Post intervention, on average 6 months
Secondary	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.	Pre and Post intervention, on average 6 months