None listed
Conditions
Brief summary
The purpose of this study is to determine whether intra-infusion exercise (exercise during chemotherapy infusion) can also improve chemotherapy side effects and physical activity levels in patients with breast, colorectal and ovarian cancer. Who is it for? You may be eligible for this study if you are aged between 18-75 years old, have been diagnosed with Stage I-III breast, colorectal or ovarian cancer, and are currently undergoing or are planned to undergo chemotherapy. Study details The study consists of four chemotherapy treatment sessions with the first being used to obtain baseline measures, followed by three intervention sessions. After the initial baseline session, participants will be randomised (i.e. allocated by chance) to either an intra-infusion exercise group or usual-care control group. For each of the three intervention sessions, the exercise group will perform 20 minutes of moderate intensity aerobic exercise during the chemotherapy infusion period. The control group will continue with routine clinical care. During the recovery period, the exercise group will be provided with exercise education by an accredited exercise physiologist. The control group will be involved in an education session during the infusion with the accredited exercise physiologist to receive the same exercise education as the exercise group. All participants will wear an Actigraph (a movement-detecting device) for one week following the baseline and post-intervention session and complete a 7-day symptom diary following each intervention session. A Fitbit will be worn continuously by the participant for the duration of the study to capture daily physical activity. Participants will also fill out a number of questionnaires before and after completion of the study. Participants will be asked if they would like to participate in an optional exit interview with a member of the research team at the end of the study. It is hoped that this study may demonstrate that intra-infusion exercise reduces chemotherapy side effects, improves quality of life, and increases physical activity levels in patients with breast, colorectal or ovarian cancer undergoing chemotherapy.
Interventions
The exercise intervention will be delivered for 3 sessions in a one-on-one setting with an accredited exercise physiologist when patients have their scheduled chemotherapy infusion. The duration of the study will depend on the frequency of chemotherapy infusions which is variable between individuals.
Exercise will involve the participant cycling on a stationary foot bike whilst seated in their usual chemotherapy chair for 20 minutes continuously at a moderate intensity (40-50% heart rate reserv
The exercise intervention will be delivered for 3 sessions in a one-on-one setting with an accredited exercise physiologist when patients have their scheduled chemotherapy infusion. The duration of the study will depend on the frequency of chemotherapy infusions which is variable between individuals. Exercise will involve the participant cycling on a stationary foot bike whilst seated in their usual chemotherapy chair for 20 minutes continuously at a moderate intensity (40-50% heart rate reserve and a rate of perceived exertion 12-14). Pre-task will commence after 10 minutes of chemotherapy infusion to confirm the absence of adverse reactions to the infusion. Physiological measures will be recorded during pre-task (10 minutes), task (exercise, 20 minutes) and recovery (20 minutes). These measures include heart rate, blood pressure and oxygen saturation. Rating of perceived exertion using the Borg RPE scale will also be measured during the task. Adherence will be monitored by session attendance checklists. During the recovery period, the exercise group will be provided with exercise education by an accredited exercise physiologist. The initial exercise education session will involve the accredited exercise physiologist discussing goal setting, barriers to exercise, current exercise knowledge and exercise history. The accredited exercise physiologist will use an education booklet in subsequent sessions to address strategies to overcome exercise barriers. The “Exercise for People Living with Cancer; A guide for people with cancer, their families and friends” booklet by the Cancer Council will be used as a supplementary booklet for participants who would like more information about resistance exercise.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
a. Voluntarily signed the informed consent form b. Ability to speak and understand English c. Aged between 18-75 years old d. Histologically confirmed Stage I-III breast, colorectal or ovarian cancer e. Current or planned chemotherapy f. Undergone at least 1 cycle of chemotherapy g. Plan on receiving at least 4 chemotherapy cycles with duration >60 minutes h. Treating oncologist approval i. ECOG 0-2 j. Willingness and ability to comply with all study procedures
Exclusion criteria
a. Present with an acute systemic infection or fever b. Known adverse reaction to infusion c. Presence of any condition that is contraindicated to exercise d. Presence of orthopaedic problems, significant peripheral neuropathy or pain that would limit lower body exercise e. Currently taking beta-blocker medication f. Currently undergoing immunotherapy g. Currently receiving anthracycline
Outcome results
None listed