Breast Cancer FemaleB-HAPINCT04621721
Home-Based Physical Activity Intervention for Taxane-Induced CIPN
A study testing Gait/balance & resistive exercise in people with Breast Cancer Female and Chemotherapy-induced Peripheral Neuropathy, run by University of South Florida at 1 site in United States.
Trial summary
This two-group, randomized control trial (RCT) will test the effects of a home-based, 16 week gait/balance training plus resistance (exercise bands) exercise program as compared to an educational cancer survivorship attention control condition to address persistent taxane-induced peripheral neuropathy in 312 patients… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Chemotherapy-induced Peripheral Neuropathy, Gait Disorders, Neurologic
- What is being tested?
- Gait/balance & resistive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 30 Sep 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer survivors (>21) with who completed treatment for invasive breast cancer with taxane-based chemotherapy, and who have a peripheral neuropathy score of > 3 by VAS rating consistent with studies of diabetic peripheral neuropathy.
Who cannot join
- any disease (e.g. diabetes, HIV) that results in peripheral neuropathy or muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke,); any disease that would preclude exercise (preexisting cardiopulmonary disease, bone metastasis). Individuals with symptomatic lymphedema or advanced 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, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Constance Visovsky, 813-974-3831, cvisovsk@usf.edu
Jillian Coury, 8139745117, coury@usf.edu
About this study
This two-group, randomized control trial (RCT) will test the effects of a home-based, 16 week gait/balance training plus resistance (exercise bands) exercise program as compared to an educational cancer survivorship attention control condition to address persistent taxane-induced peripheral neuropathy in 312 patients treated for invasive breast cancer with taxanes at 1 year or more after completion of therapy. Assessments of lower extremity muscle strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will be performed.
The proposed exercise intervention addresses gait/balance impairments and motor (resistance) components of taxane-induced peripheral neuropathy. The mechanism by which the intervention achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and clinical manifestations of peripheral neuropathy, while improving gait/balance in those with persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria to function more efficiently, and may alleviate the neuropathic manifestations of taxane-induced peripheral neuropathy. 15
Read more
This is the first study proposing to test the home-delivery of an exercise intervention specifically aimed at persistent (long-term) taxane-induced neuropathy. If successful, this study will provide the only evidence-based intervention for patients suffering from persistent neuropathy from neurotoxic chemotherapy. Additionally, the home-delivery format makes this intervention easily translated into clinical practice.
Specific Aims:
In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of this RCT are:
- To test the efficacy of a 16-week -delivered program of gait/balance training plus resistance exercise, compared to an educational attention control condition in increasing muscle strength, improving gait/balance and nerve conduction parameters, decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing quality of life.
- To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor (peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL) between patients who receive the exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles and intervals, neuropathic pain, neuropathy/pain medications, current resistance exercise participation and falls/near falls experienced.
Read the detailed description
The use of taxanes in breast cancer chemotherapy regimens is considered standard first line therapy.1 However, taxanes are known to induce peripheral neuropathy, from 59-87% for paclitaxel and from 11-64% for docetaxel. 2-4 Sensory manifestations can include pain; numbness, tingling, \& burning; diminished proprioception, and decreased vibration and touch sensation. 5-6 Motor symptoms such as lower extremity muscle weakness and impaired balance has been reported. 7 Currently, peripheral neuropathy remains a significant toxicity resulting in taxane chemotherapy dose reductions or discontinuation, with no evidence-based preventative or treatment strategies are available. 8 Taxanes induce sensory and motor neuropathy by inducing both mitochondrial and vascular dysfunction.9 In rodents, treatment with taxanes resulted in swollen, vacuolated axonal mitochondria that are functionally impaired, producing a chronic energy deficit.10 In addition, toxic effects to the endothelial cells of the vasa nervorum (small arterioles that supply peripheral nerves) in the dorsal root ganglia attenuates blood flow to neurons, resulting in endothelial cell death. 11 These findings suggest that both mitochondrial impairment and vascular damage are major mechanisms that underlie the development of taxane-induced peripheral neuropathy, manifesting as sensory manifestations and neuropathic pain. 9-12
Mitochondrial and vascular dysfunctions lead to sensory loss and reduced muscle strength, functions dependent upon cellular mitochondria to generate energy in the form of ATP (adenosine triphosphate). Thus, mitochondrial dysfunction results in the loss of energy-generating capability, and vascular impairment deprives muscle and nerve cells of oxygen-rich nutrients, further impairing neuronal function. A limited number of human and animal studies have demonstrated that exercise stimulates endothelium-dependent vasodilation and vascular endothelial growth factor (VEGF) expression, increasing endoneurial blood flow and energy generating capacity through mitochondrial protein synthesis and glycolysis, 13, 14
The proposed exercise intervention addresses gait/balance impairments and motor (resistance) components of taxane-induced peripheral neuropathy. The mechanism by which the intervention achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and clinical manifestations of peripheral neuropathy, while improving gait/balance in those with persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria to function more efficiently, and may alleviate the neuropathic manifestations of taxane-induced peripheral neuropathy.
Specific Aims:
In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of this RCT are:
- To test the efficacy of a 16-week -delivered program of gait/balance training plus resistance exercise, compared to an educational attention control condition in increasing muscle strength, improving gait/balance and nerve conduction parameters, decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing quality of life.
- To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor (peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL) between patients who receive the exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles and intervals, neuropathic pain, neuropathy/pain medications, current resistance exercise participation and falls/near falls experienced
- Conditions
- Breast Cancer Female, Chemotherapy-induced Peripheral Neuropathy, Gait Disorders, Neurologic, Balance; Distorted, Muscle Weakness
- Being tested
- Gait/balance & resistive exercise
- Medical subject headings
- Gait Disorders, Neurologic, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait/balance & resistive exerciseBehavioural
Walking forward and back, walking with head motion, static standing, Standing Partial Tandem, Tandem Standing heel to toe, Standing with head turns Single leg stance and March in place. Resistance exercises include: calf raises, lunges, supine leg curls and extensions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention will consist of a 16-week, home-based gait/balance training and progressive resistance exercises for lower extremities using resistance power bands. Participants will be given the home-based gait/balance training and progressive resistance exercise training access via a link or by DVD, and the resistance training band, and wide, firm foam surface. The intervention group will begin with light warm-up and stretching activity then a 10 minute each of gait/balance and 10 minutes of resistive (strength) training components. The program begins with light stretching to address any range of motion limitations that may affect ability to maintain balance and postural stability, and consisted of hamstring quadricep, gastroc, and soleus stretches. During stretching exercises, participants held each stretch for 10-15 seconds, repeating each stretch 2-3 times for each lower extremity. Stretching exercises do not change during the intervention. Receives: Behavioral: Gait/balance & resistive exercise |
| Attention Control Group | Active comparator | The Attention Control group will receive an educational intervention via a journal in which to record their clinic appointments, and standardized American Cancer Society pamphlets which have been adjusted to fit within the journal binding for easy reference. At each data collection encounter, the intervention research assistant will discuss the information in each pamphlet, allowing time for questions related to the material. The educational materials consist of 1) Emotions and Breast Cancer; 2) Body Image and Sexuality After Breast Cancer; 3) Follow up Care After Breast Cancer Treatment; 4) Nutrition and Cancer. Sessions last approximately 45-60 minutes and occur at the same intervals as the intervention group and will precede data collection. Attention Control group participants will receive telephone calls every other week which will entail a social visit and reminder of data collection/attention intervention appointments to further equalize contact. Receives: Behavioral: Gait/balance & resistive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Change
Gait analysis will be performed using a GAITRite System with 3D motion capture with integrated force platform. Gait variables to be used in analysis are ankle plantar/flexor torque
Measured: Change from Baseline to week 16
Balance Change
Balance analysis will be performed using the Neurocom Balance Master Sensory Organization Test
Measured: Change from Baseline to week 16
Change in Lower Extremity Muscle Strength
Isokinetic dynamometry (Biodex 3.0) Hip flexors, hip abductors, knee flexors, knee extensors, and ankle dorsiflexors will be tested
Measured: Change from Baseline to week 16
Change in Lower Extremity Nerve Conduction
Nerve conduction studies of the sural \& peroneal nerve action potentials will be tested by Dr. Vu, USF Department of Neurology.
Measured: Change from Baseline to week 16
Change in Neuropathy Symptoms
FACT-Taxane Additional Concerns subscale53 Addresses symptoms specific to neuropathy. Likert scale: 0 (not at all) - 4 (very much).
Measured: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Neuropathy Quality of Life
FACT-Taxane (version 4) 54 A total Quality of Life score can be obtained by summing the subscale scores and will be used for in the data analysis.
Measured: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary outcomes (4)
Change in Neuropathic Pain
Brief Pain Inventory assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours
Measured: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Body Mass Index
A portable Tanita Body Composition Analyzer will be used to obtain each participant's weight and body mass index (BMI) through bioelectrical impedance.
Measured: Change from Baseline to week16
Change in Neuropathy or Pain Medications
Medications used for neuropathy pain will be monitored and documented throughout the study, and coded into drug classifications, and dosage change/no change tracked for analysis
Measured: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Falls or near falls in last month
participant will self-report (yes/no) if they have fallen or had a near fall within the last month.
Measured: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start14 Aug 2020
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621721
- Sponsor's protocol ID
- Pro00040035
- Other IDs
- 1R01CA229681-01A1
- Acronym
- B-HAPI
- Status last verified
- Jul 2020
- First submitted
- 3 Aug 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozorio Dutra SV, Schwab L, Coury J, Ji M, Visovsky C. Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial. BMC Cancer. 2024 Jun 27;24(1):777. doi: 10.1186/s12885-024-12444-x.
PubMed 38937667Teran-Wodzinski P, Haladay D, Vu T, Ji M, Coury J, Adams A, Schwab L, Visovsky C. Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial. Trials. 2022 Apr 27;23(1):363. doi: 10.1186/s13063-022-06294-w.
PubMed 35477489
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Physical Activity Intervention for Taxane-Induced CIPN
- ClinicalTrials.gov ID
- NCT04621721
- Acronym / sponsor ID
- B-HAPI / Pro00040035
- Conditions
- Breast Cancer Female, Chemotherapy-induced Peripheral Neuropathy, Gait Disorders, Neurologic, Balance; Distorted, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 9 Nov 2020 (actual)
- 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 two-group, randomized control trial (RCT) will test the effects of a home-based, 16 week gait/balance training plus resistance (exercise bands) exercise program as compared to an educational cancer survivorship attention control condition to address persistent taxane-induced peripheral neuropathy in 312 patients treated for invasive breast cancer with taxanes at 1 year or more after completion of therapy. Assessments of lower extremity muscle strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will be performed.
The proposed exercise intervention addresses gait/balance impairments and motor (resistance) components of taxane-induced peripheral neuropathy. The mechanism by which the intervention achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and clinical manifestations of peripheral neuropathy, while improving gait/balance in those with persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria to function more efficiently, and may alleviate the neuropathic manifestations of taxane-induced peripheral neuropathy. 15
This is the first study proposing to test the home-delivery of an exercise intervention specifically aimed at persistent (long-term) taxane-induced neuropathy. If successful, this study will provide the only evidence-based intervention for patients suffering from persistent neuropathy from neurotoxic chemotherapy. Additionally, the home-delivery format makes this intervention easily translated into clinical practice.
Specific Aims:
In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of this RCT are:
- To test the efficacy of a 16-week -delivered program of gait/balance training plus resistance exercise, compared to an educational attention control condition in increasing muscle strength, improving gait/balance and nerve conduction parameters, decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing quality of life.
- To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor (peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL) between patients who receive the exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles and intervals, neuropathic pain, neuropathy/pain medications, current resistance exercise participation and falls/near falls experienced.
Detailed description
The use of taxanes in breast cancer chemotherapy regimens is considered standard first line therapy.1 However, taxanes are known to induce peripheral neuropathy, from 59-87% for paclitaxel and from 11-64% for docetaxel. 2-4 Sensory manifestations can include pain; numbness, tingling, \& burning; diminished proprioception, and decreased vibration and touch sensation. 5-6 Motor symptoms such as lower extremity muscle weakness and impaired balance has been reported. 7 Currently, peripheral neuropathy remains a significant toxicity resulting in taxane chemotherapy dose reductions or discontinuation, with no evidence-based preventative or treatment strategies are available. 8 Taxanes induce sensory and motor neuropathy by inducing both mitochondrial and vascular dysfunction.9 In rodents, treatment with taxanes resulted in swollen, vacuolated axonal mitochondria that are functionally impaired, producing a chronic energy deficit.10 In addition, toxic effects to the endothelial cells of the vasa nervorum (small arterioles that supply peripheral nerves) in the dorsal root ganglia attenuates blood flow to neurons, resulting in endothelial cell death. 11 These findings suggest that both mitochondrial impairment and vascular damage are major mechanisms that underlie the development of taxane-induced peripheral neuropathy, manifesting as sensory manifestations and neuropathic pain. 9-12
Mitochondrial and vascular dysfunctions lead to sensory loss and reduced muscle strength, functions dependent upon cellular mitochondria to generate energy in the form of ATP (adenosine triphosphate). Thus, mitochondrial dysfunction results in the loss of energy-generating capability, and vascular impairment deprives muscle and nerve cells of oxygen-rich nutrients, further impairing neuronal function. A limited number of human and animal studies have demonstrated that exercise stimulates endothelium-dependent vasodilation and vascular endothelial growth factor (VEGF) expression, increasing endoneurial blood flow and energy generating capacity through mitochondrial protein synthesis and glycolysis, 13, 14
The proposed exercise intervention addresses gait/balance impairments and motor (resistance) components of taxane-induced peripheral neuropathy. The mechanism by which the intervention achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and clinical manifestations of peripheral neuropathy, while improving gait/balance in those with persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria to function more efficiently, and may alleviate the neuropathic manifestations of taxane-induced peripheral neuropathy.
Specific Aims:
In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of this RCT are:
- To test the efficacy of a 16-week -delivered program of gait/balance training plus resistance exercise, compared to an educational attention control condition in increasing muscle strength, improving gait/balance and nerve conduction parameters, decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing quality of life.
- To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor (peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL) between patients who receive the exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles and intervals, neuropathic pain, neuropathy/pain medications, current resistance exercise participation and falls/near falls experienced
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Gait/balance & resistive exerciseThe intervention will consist of a 16-week, home-based gait/balance training and progressive resistance exercises for lower extremities using resistance power bands. Participants will be given the home-based gait/balance training and progressive resistance exercise training access via a link or by DVD, and the resistance training band, and wide, firm foam surface. The intervention group will begin with light warm-up and stretching activity then a 10 minute each of gait/balance and 10 minutes of resistive (strength) training components. The program begins with light stretching to address any range of motion limitations that may affect ability to maintain balance and postural stability, and consisted of hamstring quadricep, gastroc, and soleus stretches. During stretching exercises, participants held each stretch for 10-15 seconds, repeating each stretch 2-3 times for each lower extremity. Stretching exercises do not change during the intervention. |
| Attention Control Group | Active comparator | Behavioral: Gait/balance & resistive exerciseThe Attention Control group will receive an educational intervention via a journal in which to record their clinic appointments, and standardized American Cancer Society pamphlets which have been adjusted to fit within the journal binding for easy reference. At each data collection encounter, the intervention research assistant will discuss the information in each pamphlet, allowing time for questions related to the material. The educational materials consist of 1) Emotions and Breast Cancer; 2) Body Image and Sexuality After Breast Cancer; 3) Follow up Care After Breast Cancer Treatment; 4) Nutrition and Cancer. Sessions last approximately 45-60 minutes and occur at the same intervals as the intervention group and will precede data collection. Attention Control group participants will receive telephone calls every other week which will entail a social visit and reminder of data collection/attention intervention appointments to further equalize contact. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female breast cancer survivors (>21) with who completed treatment for invasive breast cancer with taxane-based chemotherapy, and who have a peripheral neuropathy score of > 3 by VAS rating consistent with studies of diabetic peripheral neuropathy.
Key exclusion criteria (1 listed)
- any disease (e.g. diabetes, HIV) that results in peripheral neuropathy or muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke,); any disease that would preclude exercise (preexisting cardiopulmonary disease, bone metastasis). Individuals with symptomatic lymphedema or advanced 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 |
|---|---|---|
| Gait/balance & resistive exerciseWalking forward and back, walking with head motion, static standing, Standing Partial Tandem, Tandem Standing heel to toe, Standing with head turns Single leg stance and March in place. Resistance exercises include: calf raises, lunges, supine leg curls and extensions. | Behavioural | Attention Control Group, Intervention Group |
Primary outcome
Gait Change
Time frame: Change from Baseline to week 16
Gait analysis will be performed using a GAITRite System with 3D motion capture with integrated force platform. Gait variables to be used in analysis are ankle plantar/flexor torque
Balance Change
Time frame: Change from Baseline to week 16
Balance analysis will be performed using the Neurocom Balance Master Sensory Organization Test
Change in Lower Extremity Muscle Strength
Time frame: Change from Baseline to week 16
Isokinetic dynamometry (Biodex 3.0) Hip flexors, hip abductors, knee flexors, knee extensors, and ankle dorsiflexors will be tested
Change in Lower Extremity Nerve Conduction
Time frame: Change from Baseline to week 16
Nerve conduction studies of the sural \& peroneal nerve action potentials will be tested by Dr. Vu, USF Department of Neurology.
Change in Neuropathy Symptoms
Time frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
FACT-Taxane Additional Concerns subscale53 Addresses symptoms specific to neuropathy. Likert scale: 0 (not at all) - 4 (very much).
Neuropathy Quality of Life
Time frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
FACT-Taxane (version 4) 54 A total Quality of Life score can be obtained by summing the subscale scores and will be used for in the data analysis.
4 secondary outcomes
Change in Neuropathic Pain
Time frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Body Mass Index
Time frame: Change from Baseline to week16
Change in Neuropathy or Pain Medications
Time frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Falls or near falls in last month
Time frame: Change over time from Baseline to 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 38937667Ozorio Dutra SV, Schwab L, Coury J, Ji M, Visovsky C. Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial. BMC Cancer. 2024 Jun 27;24(1):777. doi: 10.1186/s12885-024-12444-x.
- Derived from this study: PubMed 35477489Teran-Wodzinski P, Haladay D, Vu T, Ji M, Coury J, Adams A, Schwab L, Visovsky C. Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial. Trials. 2022 Apr 27;23(1):363. doi: 10.1186/s13063-022-06294-w.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait/balance & resistive exercise in people with Breast Cancer Female and Chemotherapy-induced Peripheral Neuropathy, run by University of South Florida 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 1 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 9 Nov 2020. 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?
Contact Constance Visovsky (8139743831, cvisovsk@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Change (time frame: Change from Baseline to week 16). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621721, which also lists 2 linked publications.
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 9 Nov 2020.