Cancer, BreastNCT02991677
Exercise Effect on Chemotherapy-Induced Neuropathic Pain
A study testing aerobic exercise intervention and resistive training in people with Cancer, Breast and Cancer, Colorectal, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Cancer, Breast, Cancer, Colorectal, Cancer, Lung
- What is being tested?
- aerobic exercise intervention and resistive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to Dec 2025
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with cancer, stage I-IV
- History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
- Completion of chemotherapy > 6 months < 1 year
- Ability to walk on a treadmill
- Medical clearance from oncologist or primary care provider
- Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death)
- Score on Neuropathic Pain Scale >1
- Age 21-70
Who cannot join
- Denial of CIPN
- Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
- Coronary artery disease
- History of >1 chemotherapy regimen
- Musculoskeletal conditions which preclude participation in an exercise training program
- Pregnancy
- Regular exerciser, defined as >90 minutes per week of aerobic exercise and any resistive training
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.
- Conditions
- Cancer, Breast, Cancer, Colorectal, Cancer, Lung, Cancer, Ovarian
- Being tested
- aerobic exercise intervention, control group, resistive training
- Keywords
- exercise, neuropathy
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise interventionBehavioural
Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
control groupOther
weekly contact by study staff with survivorship information offered not related to neuropathy.
resistive trainingBehavioural
Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| control | Other | This is an attention control group with regular contact by study staff. Receives: Other: control group |
| aerobic exercise | Experimental | Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site. Receives: Behavioral: aerobic exercise intervention |
| resistive training | Experimental | Intervention is for 12 weeks 3 times weekly with training on site. Receives: Behavioral: resistive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory pain
Thermal, mechanical, and vibration sensation by quantitative sensory testing
Measured: 13 weeks
Secondary outcomes (1)
Nerve fiber density
laboratory examination of skin biopsy samples for measurement of nerve fiber density
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start1 Mar 2018
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alice S. Ryan, PhD, Baltimore VA Medical Center
- Investigators
- Alice Ryan, PhD, Principal investigator, University of Maryland at Baltimore School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991677
- Sponsor's protocol ID
- HP-00070946
- Status last verified
- Aug 2024
- First submitted
- 30 Nov 2016
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers
- ClinicalTrials.gov ID
- NCT02991677
- Acronym / sponsor ID
- HP-00070946
- Conditions
- Cancer, Breast, Cancer, Colorectal, Cancer, Lung, Cancer, Ovarian
- Keywords
- exercise, neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Dec 2016 (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.
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Other | Other: control groupThis is an attention control group with regular contact by study staff. |
| aerobic exercise | Experimental | Behavioral: aerobic exercise interventionAerobic exercise intervention is for 12 weeks 3 times weekly with training on site. |
| resistive training | Experimental | Behavioral: resistive trainingIntervention is for 12 weeks 3 times weekly with training on site. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis with cancer, stage I-IV
- History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
- Completion of chemotherapy > 6 months < 1 year
- Ability to walk on a treadmill
- Medical clearance from oncologist or primary care provider
Key exclusion criteria (7 listed)
- Denial of CIPN
- Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
- Coronary artery disease
- History of >1 chemotherapy regimen
- Musculoskeletal conditions which preclude participation in an exercise training program
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 |
|---|---|---|
| aerobic exercise interventionExercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks. | Behavioural | aerobic exercise |
| control groupweekly contact by study staff with survivorship information offered not related to neuropathy. | Other | control |
| resistive trainingExercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks | Behavioural | resistive training |
Primary outcome
Sensory pain
Time frame: 13 weeks
Thermal, mechanical, and vibration sensation by quantitative sensory testing
1 secondary outcome
Nerve fiber density
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
Alice Ryan, PhD principal investigator
University of Maryland at Baltimore School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise intervention and resistive training in people with Cancer, Breast and Cancer, Colorectal, run by Baltimore VA Medical Center at 1 site in United States.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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 United States. 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?
Results are not available in the source record.
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?
Sensory pain (time frame: 13 weeks). 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 6 Aug 2024.