Breast NeoplasmsEXITNCT02473861
EXercise Influence on Taxane Side Effects (EXIT) Study
A study testing Exercise in people with Breast Neoplasms, run by University of British Columbia at 1 site in Canada.
Trial summary
This study is a randomized control cross over trial of exercise training during or after taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise training for 8-12 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Born female
- Age 19 or older
- Histologically confirmed stage I-IIIA breast cancer diagnosis
- Scheduled to receive neoadjuvant or adjuvant taxane-containing chemotherapy
- Willing and able to attend baseline assessment prior to first taxane-containing treatment
- Have reliable transportation to attend our exercise gym located near the Vancouver BCCA three times weekly for 8-13 weeks
- Be able to read and communicate in English
- Treating medical oncologist approval to participate
Who cannot join
- Receipt of further chemotherapy treatments after taxane-containing treatments
- Stage IV cancer
- Acute or uncontrolled health conditions including heart disease, respiratory disease (COPD or severe asthma)
- Diagnosis of diabetes at any time
- Personal history of neurological disorder
- Mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (includes orthopedic injury or arthritis that result in inability to exercise)
- Body mass index ≥40 kg/m2
- Previously received chemotherapy or thoracic radiation treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Breast Cancer Training Center, 614 W. 8th Ave
Vancouver, British Columbia, V5Z 1C8
About this study
This study is a randomized control cross over trial of exercise training during or after taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise training for 8-12 weeks. The immediate exercise group will exercise during taxane chemotherapy and the delayed group will start exercise 2 weeks after completion of treatment. This design will allow for an assessment of the effects of exercise vs usual care during treatment, plus a comparison of the training response during vs. after chemotherapy.
Read the detailed description
Purpose The purpose of this study is to evaluate the effects of aerobic and resistance exercise training relative to usual care during taxane-containing chemotherapy treatment for breast cancer.
Hypotheses
Relative to usual care, aerobic and resistance exercise training during taxane-containing chemotherapy treatment for breast cancer will:
- mitigate the experience of patient reported outcomes
- reduce medical management of taxane side effects and adverse events
- attenuate autonomic dysfunction and maintain resting cardiovascular function and cardiovascular response to exercise
- Objectives The primary aim of this study is to determine whether aerobic and resistance exercise training during taxane-containing chemotherapy treatment reduces patient-reported side effects, medical management and clinical adverse events reported relative to usual care. The secondary aim is to determine the whether aerobic and resistance exercise training during taxane-containing chemotherapy attenuates the occurrence of indices of autonomic dysfunction relative to usual care.
- Research methods This study is a randomized control trial with crossover. The intervention consists of aerobic, resistance and balance training three times a week. Forty-three women with a stage I-III breast cancer diagnosis who are scheduled to receive taxane-containing chemotherapy will be randomized to immediate or delayed exercise (stratified by treatment protocol). Potential participants will be referred by oncologist referral, or will be self-referred by recruitment posters, social media or word of mouth.
- Statistical analysis The primary outcome measure is the EORTC CIPN subscale of patient-reported symptoms related to neurotoxic chemotherapy. Secondary outcome measures include measures of autonomic dysfunction including heart rate and blood pressure variability, and medical management of taxane-related side effects, and clinical adverse events related to treatment.
The chemotherapy-induced peripheral neuropathy (CIPN) sub-scale of the EORTC Quality of life Questionnaire is used as the primary outcome measure to determine sample size. G*Power 3.0.10 was used to estimate sample size for independent t-tests between the two groups (at the 2-week post chemotherapy time point). At thirty-six participants, we will have 80% power to detect a medium (d=0.6) effect size in the EORTC CIPN-20 subscale at an alpha of 0.05 (one-tailed) . An additional 20% will be recruited to allow for dropout or non-adherence, making the final total sample size goal 43 participants.
Baseline characteristics and outcome measures of the two groups will be compared with independent t-tests. To assess the effect of the exercise intervention during treatment, independent t-tests will be used to compare the outcome measures at two weeks post completion of taxane chemotherapy if no difference exists between groups baseline measures. For the exercise group, all outcome measures at time point 2 will be compared to time point 3 using paired t-tests to assess maintenance over time. Independent t-tests will first be used to determine whether significant differences exists between groups for the three exploratory measure time points. If no differences exist, all data will be combined, and analyzed with a repeated measures analysis of variance to determine whether differences exist.
- Conditions
- Breast Neoplasms
- Being tested
- Exercise
- Keywords
- exercise training, breast cancer, taxane chemotherapy, peripheral neuropathy, fatigue, autonomic function
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Moderate intensity aerobic and resistance training. Five minutes each of warm-up, cool-down, balance and flexibility will also be performed.
| Study group | Role | What they receive |
|---|---|---|
| Immediate exercise arm | Experimental | The length of the intervention for the immediate exercise group will be determined by treatment protocol and could range from 8 to 13 weeks. The intervention can begin up to one week before the first treatment and will continue until 2 weeks after the final taxane-containing treatment. The intervention will consist of thrice weekly supervised aerobic and resistance exercise training. Receives: Other: Exercise |
| delayed exercise arm | Experimental | The delayed exercise group will begin an exercise intervention two weeks after completion of their last taxane-containing chemotherapy treatment that will last the length of their taxane chemotherapy plus two weeks. If participants in the delayed exercise group have a surgery planned during the intervention time that will require >1 week off from exercise, the exercise intervention will be delayed until after the surgery. The intervention will consist of thrice weekly supervised aerobic and resistance exercise training. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change with treatment and maintenance post treatment in patient-reported taxane-related symptoms via the EORTC CIPN subscale
European Organization for Research and Treatment of Cancer CIPN subscale
Measured: 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy
Secondary outcomes (4)
Change with treatment and maintenance post treatment of heart rate variability
Electrocardiography will be used to assess heart rate variability during 10 minutes of supine rest
Measured: 14-0 days pre taxane chemotherapy, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion taxane chemotherapy
Change with treatment and maintenance post treatment of blood pressure variability
A Finometer will be used to assess blood pressure variability from supine to standing posture
Measured: 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy
Number of participants requiring medical management of taxane side effects
Prescription of medications, dose delays, dose reductions will be abstracted from cancer treatment records
Measured: Will be extracted from medical records 0-6 months after completion of chemotherapy
Number of participants with clinical reporting of adverse events during taxane-chemotherapy treatment
Oncological treatment notes will be reviewed for clinical notation of adverese events during taxane treatment
Measured: Will be extracted from medical records 0-6 months after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Campbell, University of British Columbia
- Investigators
- Kristin L Campbell, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473861
- Sponsor's protocol ID
- H15-00888
- Acronym
- EXIT
- Status last verified
- Feb 2019
- First submitted
- 9 Jun 2015
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise Influence on Taxane Side Effects (EXIT) Study
- ClinicalTrials.gov ID
- NCT02473861
- Acronym / sponsor ID
- EXIT / H15-00888
- Conditions
- Breast Neoplasms
- Keywords
- exercise training, breast cancer, taxane chemotherapy, peripheral neuropathy, fatigue, autonomic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized control cross over trial of exercise training during or after taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise training for 8-12 weeks. The immediate exercise group will exercise during taxane chemotherapy and the delayed group will start exercise 2 weeks after completion of treatment. This design will allow for an assessment of the effects of exercise vs usual care during treatment, plus a comparison of the training response during vs. after chemotherapy.
Detailed description
Purpose The purpose of this study is to evaluate the effects of aerobic and resistance exercise training relative to usual care during taxane-containing chemotherapy treatment for breast cancer.
Hypotheses
Relative to usual care, aerobic and resistance exercise training during taxane-containing chemotherapy treatment for breast cancer will:
- mitigate the experience of patient reported outcomes
- reduce medical management of taxane side effects and adverse events
- attenuate autonomic dysfunction and maintain resting cardiovascular function and cardiovascular response to exercise
- Objectives The primary aim of this study is to determine whether aerobic and resistance exercise training during taxane-containing chemotherapy treatment reduces patient-reported side effects, medical management and clinical adverse events reported relative to usual care. The secondary aim is to determine the whether aerobic and resistance exercise training during taxane-containing chemotherapy attenuates the occurrence of indices of autonomic dysfunction relative to usual care.
- Research methods This study is a randomized control trial with crossover. The intervention consists of aerobic, resistance and balance training three times a week. Forty-three women with a stage I-III breast cancer diagnosis who are scheduled to receive taxane-containing chemotherapy will be randomized to immediate or delayed exercise (stratified by treatment protocol). Potential participants will be referred by oncologist referral, or will be self-referred by recruitment posters, social media or word of mouth.
- Statistical analysis The primary outcome measure is the EORTC CIPN subscale of patient-reported symptoms related to neurotoxic chemotherapy. Secondary outcome measures include measures of autonomic dysfunction including heart rate and blood pressure variability, and medical management of taxane-related side effects, and clinical adverse events related to treatment.
The chemotherapy-induced peripheral neuropathy (CIPN) sub-scale of the EORTC Quality of life Questionnaire is used as the primary outcome measure to determine sample size. G*Power 3.0.10 was used to estimate sample size for independent t-tests between the two groups (at the 2-week post chemotherapy time point). At thirty-six participants, we will have 80% power to detect a medium (d=0.6) effect size in the EORTC CIPN-20 subscale at an alpha of 0.05 (one-tailed) . An additional 20% will be recruited to allow for dropout or non-adherence, making the final total sample size goal 43 participants.
Baseline characteristics and outcome measures of the two groups will be compared with independent t-tests. To assess the effect of the exercise intervention during treatment, independent t-tests will be used to compare the outcome measures at two weeks post completion of taxane chemotherapy if no difference exists between groups baseline measures. For the exercise group, all outcome measures at time point 2 will be compared to time point 3 using paired t-tests to assess maintenance over time. Independent t-tests will first be used to determine whether significant differences exists between groups for the three exploratory measure time points. If no differences exist, all data will be combined, and analyzed with a repeated measures analysis of variance to determine whether differences exist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate exercise arm | Experimental | Other: ExerciseThe length of the intervention for the immediate exercise group will be determined by treatment protocol and could range from 8 to 13 weeks. The intervention can begin up to one week before the first treatment and will continue until 2 weeks after the final taxane-containing treatment. The intervention will consist of thrice weekly supervised aerobic and resistance exercise training. |
| delayed exercise arm | Experimental | Other: ExerciseThe delayed exercise group will begin an exercise intervention two weeks after completion of their last taxane-containing chemotherapy treatment that will last the length of their taxane chemotherapy plus two weeks. If participants in the delayed exercise group have a surgery planned during the intervention time that will require >1 week off from exercise, the exercise intervention will be delayed until after the surgery. The intervention will consist of thrice weekly supervised aerobic and resistance exercise training. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Born female
- Age 19 or older
- Histologically confirmed stage I-IIIA breast cancer diagnosis
- Scheduled to receive neoadjuvant or adjuvant taxane-containing chemotherapy
- Willing and able to attend baseline assessment prior to first taxane-containing treatment
Key exclusion criteria (8 listed)
- Receipt of further chemotherapy treatments after taxane-containing treatments
- Stage IV cancer
- Acute or uncontrolled health conditions including heart disease, respiratory disease (COPD or severe asthma)
- Diagnosis of diabetes at any time
- Personal history of neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseModerate intensity aerobic and resistance training. Five minutes each of warm-up, cool-down, balance and flexibility will also be performed. | Other | Immediate exercise arm, delayed exercise arm |
Primary outcome
Change with treatment and maintenance post treatment in patient-reported taxane-related symptoms via the EORTC CIPN subscale
Time frame: 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy
European Organization for Research and Treatment of Cancer CIPN subscale
4 secondary outcomes
Change with treatment and maintenance post treatment of heart rate variability
Time frame: 14-0 days pre taxane chemotherapy, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion taxane chemotherapy
Change with treatment and maintenance post treatment of blood pressure variability
Time frame: 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy
Number of participants requiring medical management of taxane side effects
Time frame: Will be extracted from medical records 0-6 months after completion of chemotherapy
Number of participants with clinical reporting of adverse events during taxane-chemotherapy treatment
Time frame: Will be extracted from medical records 0-6 months after completion of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin L Campbell, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Neoplasms, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change with treatment and maintenance post treatment in patient-reported taxane-related symptoms via the EORTC CIPN subscale (time frame: 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.