Clinical trial NCT06280885: A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy
Official title: A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: St. James's Hospital, Ireland
First posted: 2024-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility randomised controlled trial using a 2:1 randomisation
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.
* 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.

Primary outcomes:
measure: Feasibility: Recruitment rates
timeFrame: At enrolement
measure: Feasibility: Adherence rates
timeFrame: Through study completion, on average 6 months
measure: Feasibility: Attendance rates
timeFrame: Through study completion, on average 6 months
measure: Feasibility: Retention Rates
timeFrame: Through study completion, on average 6 months
measure: Feasibility: Reason for drop0out
timeFrame: Through study completion, on average 6 months
Secondary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: Pre and post intervention (on average 6 months)
measure: Muscular Strength
timeFrame: Pre and Post intervention, on average 6 months
measure: Body Mass Index
timeFrame: Pre and Post intervention, on average 6 months
measure: Mid-arm circumference
timeFrame: Pre and Post intervention, on average 6 months
measure: Waist Circumference
timeFrame: Pre and Post intervention, on average 6 months
measure: Bioimpedance Analysis
timeFrame: Pre and Post intervention, on average 6 months
measure: Health Related Quality of Life
timeFrame: Pre and Post intervention, on average 6 months
measure: Fatigue
timeFrame: Pre and Post intervention, on average 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James's Hospital
Study officials:
References: