Peripheral Nervous System DisordersHOPENCT00869804
Heading Off Peripheral Neuropathy With Exercise
A study testing Aerobic/ Resistance Exercise Intervention in people with Peripheral Nervous System Disorders and Breast Neoplasms, run by University of Nebraska at 1 site in United States.
Trial summary
Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral Nervous System Disorders, Breast Neoplasms, Chemotherapy
- What is being tested?
- Aerobic/ Resistance Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2009to 13 Dec 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 19 or older with newly diagnosed Stage I-IIIa invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of CIPN.
Who cannot join
- any disease (e.g. diabetes, HIV) that results in peripheral neuropathy;
- any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease);
- any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis);
- individuals with diagnosed lymphedema or advanced disease (> Stage IIIa, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.
Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. This study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.
Read the detailed description
This pilot study will test the effects of a tailored home-based walking (aerobic) and strength training (resistance) exercise program for individuals receiving taxane-based chemotherapy for breast cancer on neuropathy, breast cancer-related symptoms, cold thermal sensation, vibratory sensation, gait \& balance, upper and lower extremity muscle strength, and quality of life.
The objective of this pilot study is to determine the effect size, feasibility and acceptability of a 12-week combination exercise program consisting of aerobic exercise (walking) and strength training for preventing or ameliorating the clinical manifestations and symptoms of CIPN in individuals with Stage I-IIIa non-metastatic breast cancer.
- Being tested
- Aerobic/ Resistance Exercise Intervention, Attention control
- Keywords
- breast cancer, chemotherapy-induced peripheral neuropathy, exercise
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic/ Resistance Exercise InterventionBehavioural
The intervention will consist of a tailored home-based program of both aerobic (walking, using pedometer) and strength training exercises for upper and lower extremities using resistance power bands.
Attention controlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | combination aerobic (walking) and resistance (strength training) exercise Receives: Behavioral: Aerobic/ Resistance Exercise Intervention |
| attention control | Sham comparator | attention control with daily journal and cancer-related education Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect size for reduction of neuropathic symptoms
effect size for reduction of neuropathic symptoms
Measured: Baseline, 4, 8 12, 24 weeks
Secondary outcomes (2)
effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy
effect size for potential covariates (age, taxane dose, baseline level of exercise participation, breast cancer-related symptoms) on measures of chemotherapy-induced peripheral neuropathy
Measured: Baseline, 4, 8, 12, 24 weeks
feasibility and acceptability of a home-based aerobic and strength training exercise program
determine the feasibility and acceptability of a home-based aerobic and strength training exercise program during and after taxane-based chemotherapy.
Measured: Baseline, 4, 8, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study start25 Mar 2009
- Primary completion13 Dec 2011
- Study completion13 Dec 2011
Why it stopped: Could not recruit total numbers needed. PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nervous System DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constance Visovsky, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869804
- Sponsor's protocol ID
- 0478-08-FB
- Acronym
- HOPE
- Status last verified
- Nov 2023
- First submitted
- 25 Mar 2009
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.
- ClinicalTrials.gov ID
- NCT00869804
- Acronym / sponsor ID
- HOPE / 0478-08-FB
- Keywords
- breast cancer, chemotherapy-induced peripheral neuropathy, exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not recruit total numbers needed. PI left institution.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 25 Mar 2009 (actual)
- Primary completion
- 13 Dec 2011 (actual)
- Study completion
- 13 Dec 2011 (actual)
- First posted
- 26 Mar 2009 (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 for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. This study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.
Detailed description
This pilot study will test the effects of a tailored home-based walking (aerobic) and strength training (resistance) exercise program for individuals receiving taxane-based chemotherapy for breast cancer on neuropathy, breast cancer-related symptoms, cold thermal sensation, vibratory sensation, gait \& balance, upper and lower extremity muscle strength, and quality of life.
The objective of this pilot study is to determine the effect size, feasibility and acceptability of a 12-week combination exercise program consisting of aerobic exercise (walking) and strength training for preventing or ameliorating the clinical manifestations and symptoms of CIPN in individuals with Stage I-IIIa non-metastatic breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Aerobic/ Resistance Exercise Interventioncombination aerobic (walking) and resistance (strength training) exercise |
| attention control | Sham comparator | Behavioral: Attention controlattention control with daily journal and cancer-related education |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 19 or older with newly diagnosed Stage I-IIIa invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of CIPN.
Key exclusion criteria (4 listed)
- any disease (e.g. diabetes, HIV) that results in peripheral neuropathy;
- any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease);
- any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis);
- individuals with diagnosed lymphedema or advanced disease (> Stage IIIa, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.
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/ Resistance Exercise InterventionThe intervention will consist of a tailored home-based program of both aerobic (walking, using pedometer) and strength training exercises for upper and lower extremities using resistance power bands. | Behavioural | Exercise |
| Attention control | Behavioural | attention control |
Primary outcome
effect size for reduction of neuropathic symptoms
Time frame: Baseline, 4, 8 12, 24 weeks
effect size for reduction of neuropathic symptoms
2 secondary outcomes
effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy
Time frame: Baseline, 4, 8, 12, 24 weeks
feasibility and acceptability of a home-based aerobic and strength training exercise program
Time frame: Baseline, 4, 8, 12, 24 weeks
Results and safety
The study was stopped early (reason given: Could not recruit total numbers needed. PI left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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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.
Constance Visovsky, PhD principal investigator
University of Nebraska
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/ Resistance Exercise Intervention in people with Peripheral Nervous System Disorders and Breast Neoplasms, run by University of Nebraska 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Dec 2023. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Could not recruit total numbers needed. PI left institution.). 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?
effect size for reduction of neuropathic symptoms (time frame: Baseline, 4, 8 12, 24 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 5 Dec 2023.