Chronic lymphocytic leukaemia Cancer Chronic lymphocytic leukaemia of B-cell type
Conditions
Interventions
STUDY DESIGN
This is a single-centre, double-armed, randomised-controlled, phase I pilot trial, designed to evaluate the safety and acceptability of an incremental, multi-modal, 16-week exercise train
Sponsors
University of Bath
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females with a diagnosis of chronic lymphocytic leukaemia, defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines as the presence of 5000 B cells per µL of peripheral blood, sustained for at least 3 months and confirmed by the blood smear, immunophenotype and in some cases genetic features of lymphoid cells (Hallek et al., 2018a) 2. Age >18 years old 3. Asymptomatic early-stage disease monitored without anti-CLL treatment 4. Physically inactive (defined by World Health Organisation as ‘an insufficient physical activity level to meet present physical activity recommendations’. Current physical activity guidelines for adults are at least 150-300 minutes of moderate-intensity aerobic physical activity, or at least 75-150 minutes of vigorous-intensity aerobic physical activity, or an equivalent combination of both throughout the week (Bull et al., 2020)) 5. Access to an appropriate electronic device (e.g. laptop, tablet or smartphone) with an appropriate wireless internet connection (and data allowance if relevant) capable of streaming video 6. All participants will have completed the full appropriate vaccination schedule including seasonal influenza, pneumococcal and COVID-19
Exclusion criteria
Exclusion criteria: 1. World Health Organisation (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status >1 2. Pregnancy 3. Deemed unsafe to exercise according to the Physical Activity Readiness Questionnaire (PARQ) 4. Any comorbidity that is likely to progress or be exacerbated over the course of the trial period (e.g. history of syncopal events, significant cardiac or respiratory events) 5. Cognitive impairment deemed a risk by the healthcare team for participation in the trial (e.g. diagnosis of neurodegenerative disease) 6. Unable to understand explanations and/or provide informed consent 7. Any condition and/or behaviour that would pose an undue personal risk or introduce bias into the trial 8. Recent blood counts at levels that are deemed to pose an undue risk by the healthcare team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety measured by recording the incidence and severity of adverse events throughout the trial period 2. Uptake measured by recording the proportion of people approached who attend screening and the proportion of people who attend screening who are deemed eligible throughout the trial period 3. Adherence measured by recording the proportion of exercise sessions prescribed that are actually completed throughout the trial period 4. Compliance measured by recording the prescribed vs actual aerobic exercise performed per exercise session throughout the trial period 5. Retention measured by recording the proportion of participants who complete baseline measures that also complete follow-up measures after 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of CLL cells in peripheral blood measured by flow cytometry at baseline and after 16 weeks 2. Immune competency measured using phenotypic and functional analyses of PBMCs, differential blood count, viral infection history, immunoglobulins, complement proteins at baseline and after 16 weeks 3. Basal inflammation measured using cytokine analysis by ELISA at baseline and after 16 weeks 4. Metabolic factors and hormone levels measured using the Daytona for glucose, insulin, growth factors at baseline and after 16 weeks 5. Clonality of tumour cells measured by PCR at baseline and after 16 weeks 6. Genetic and epigenetic features of tumour and immune cells measured by PCR at baseline and after 16 weeks 7. Cardiorespiratory fitness measured by a submaximal exercise test at baseline and after 16 weeks 8. Body strength measured by 1-rep max resistance exercises at baseline and after 16 weeks 9. Body composition measured using anthropometrics and a DEXA scan for height, weight, waist and hip circumference, fat mass and lean mass at baseline and after 16 weeks 10. Wellbeing indices including stress, fatigue, sleep, quality of life, frailty, motivation, self-efficacy, social support measured by questionnaire at baseline and after 16 weeks 11. Free-living physical activity levels including, duration, intensity, frequency, energy expenditure and sedentary time is measured via wearable technology at baseline 2, 6, 10, 14 and after 16 weeks 12. Physical function including flexibility, measured using sit-to-stand and 8ft up and go at baseline and after 16 weeks 13. Resting blood pressure and heart rate measured using an automated blood pressure cuff and a heart rate monitor at baseline and after 16 weeks 14. Left ventricular (LV) function including volumes, ejection fraction, strain, diastolic function, measured by echocardiogram at baseline and after 16 weeks 15. Left ventricular (LV) manual measures will be compared with artificial intelligence by measuring echocardio | — |
Countries
England, United Kingdom
Outcome results
None listed