Chemotherapy-induced Peripheral Neuropathy (CIPN)NCT07009717
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
An observational study of Chemotherapy-induced Peripheral Neuropathy (CIPN) and Healthy, run by University of Florida at 1 site in United States.
Trial summary
Great Toe Strength (GTS) is a potential clinical biomarker that has been associated with functional mobility and health; Additionally, GTS has been identified in the literature as one of the early symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with CIPN and age- and sex- matched healthy controls will be recruited for this study. The recruitment will primarily rely on the resources availale through and rehabilitation specialists working within the University of Florida (UF) Health Cancer Center as well as UF Health Hospitals.
Who may be able to join
- At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe
- Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)
- Within 3 - 6 months of starting chemotherapy and a confirmed diagnosis of CIPN using the current clinical reference standard of Nerve conduction study.
- At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe
- Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)
- No known health conditions that have been reported to be associated with different impairements in mobility, balance, and muscle strength (particularly in the lower extremity)
Who cannot join
- Comorbidities including but not limited to diabetes, arthritis, hypertension, thyroid disease, and heart disease, . that have been reported to be associated with the incidence of peripheral neuropathy and/or progression of CIPN.
- Toe deformities or impairments not caused by CIPN (including but not limited to hallux valgus/varus, hallux limitus, hallux rigidus, hammer toe deformity, claw toe, bunions, webbed toes)
- Self-reported impairment or impact on the strength of the foot, ankle, and/or great toe due to past medical or surgical history.
- Eligibility Criteria for Healthy Control group: The participants recruited for this group will be age- and sex- matched to the CIPN group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raghuveer Chandrashekhar, MS contact
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Hongwu Wang, PhD, 352-273-9934, hongwu.wang@phhp.ufl.edu
Hongwu Wang, PhD
About this study
Official title: The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Great Toe Strength (GTS) is a potential clinical biomarker that has been associated with functional mobility and health; Additionally, GTS has been identified in the literature as one of the early symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The purpose of this research study is to evaluate GTS in individuals with CIPN and healthy adults using ToeScale and see how it relates to nerve issues from chemotherapy. Additionally, we aim to assess the usability of the novel GTS assessment device, ToeScale among the participants. As a part of this study visit, you will complete some questionnaires followed by GTS and balance and gait assessments.
Read the detailed description
Chemotherapy-induced peripheral neuropathy, or CIPN, is a common side effect of cancer treatment. It affects about 30-40% of people with cancer and up to 100% of those who receive chemotherapy that can harm nerves. One of the early signs of CIPN is weakness in the muscles of the great toe, which is associated with movement and balance.
Current methods used to measure the strength of the great toe muscles have several drawbacks. They are not very sensitive to changes in strength, require expensive equipment or trained professionals, and can be subjective. To address these limitations, a new portable device called ToeScale was developed. This study aims to:
- Check if the ToeScale device is a valid measure of great toe strength (GTS) in people with CIPN and how different GTS is among age- and sex- matched healthy adults.
- Explore the relationship between great toe strength and the severity of CIPN symptoms.
- Assess how easy it is for participants to use the ToeScale device.
In simpler terms, this study wants to see if the new device is reliable and accurate, how well it measures GTS in people with CIPN, and whether it's easy to use.
- Being tested
- No intervention (observational study)
- Keywords
- Great Toe strength, chemotherapy-induced peripheral neuropathy, muscle weakness, clinical biomarker, force development curve
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention; observational study
| Study group | Role | What they receive |
|---|---|---|
| CIPN | Individuals with chemotherapy-induced peripheral neuropathy with a confirmed diagnosis using the nerve conduction study Receives: Other: No intervention (observational study) | |
| Healthy | Healthy adults with no known health conditions affecting their mobility, balance, or lower extremity muscle strength Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Great Toe Strength
Measured using the ToeScale, the novel device used in this study to evaluate both flexion and extension strength of the great toe
Measured: Baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)
This is a questionnaire that will be used to evaluate the severity of symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The scores from this questionnaire will be used to conduct a deeper analysis of the differences in great toe strength within the CIPN group.
Measured: Baseline
System Usability Scale (SUS) Questionnaire
This questionnaire will be administered at the end of the study visit, once the participants have a chance to use the device independently to evaluate their perspective on the satisfaction, ease of use, and comfort of the device.
Measured: Baseline
Secondary outcomes (4)
Gait analysis
Five trials of walking at a a self-selected pace will be conducted during which, a markerless motion capture system will be used for video data collection, that will then be used for gait analyses including spatiotemporal and kinematic variables.
Measured: Baseline
Balance Assessment
The HUR Smart balance platform will be used to evaluate balance using two tests: The romberg test (Stable and unstable conditions) and the limits of stability test.
Measured: Baseline
Timed Up and Go (TUG)
This is a clinical functional mobility test with a standardized protocol and measured in time (in seconds), which is currently used in clinical practice to assess fall risk. Additionally, the markerless motion capture will be used during this assessment as well to further analyze the biomechanics during different phases of the TUG assessment. We will conduct 3 trials of this assessment.
Measured: Baseline
Feedback ineterview
This is a semi-structured interview with 7 questions that we developed based on the study protocol and assessments to obtain the participants' overall perspectives on the different aspects of the study, device, and experience. This feedback will be used for secondary thematic analyses, which will inform the development of next generation of the ToeScale as well as to improve the experience of future participants that enroll in our study. This will be the last outcome to be administered to the participants at the end of the study visit.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start5 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009717
- Sponsor's protocol ID
- IRB202401631
- Status last verified
- Nov 2026
- First submitted
- 29 May 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data might be shared with permission from the funder and PI per request and as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- ClinicalTrials.gov ID
- NCT07009717
- Acronym / sponsor ID
- IRB202401631
- Keywords
- Great Toe strength, chemotherapy-induced peripheral neuropathy, muscle weakness, clinical biomarker, force development curve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (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.
Great Toe Strength (GTS) is a potential clinical biomarker that has been associated with functional mobility and health; Additionally, GTS has been identified in the literature as one of the early symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The purpose of this research study is to evaluate GTS in individuals with CIPN and healthy adults using ToeScale and see how it relates to nerve issues from chemotherapy. Additionally, we aim to assess the usability of the novel GTS assessment device, ToeScale among the participants. As a part of this study visit, you will complete some questionnaires followed by GTS and balance and gait assessments.
Detailed description
Chemotherapy-induced peripheral neuropathy, or CIPN, is a common side effect of cancer treatment. It affects about 30-40% of people with cancer and up to 100% of those who receive chemotherapy that can harm nerves. One of the early signs of CIPN is weakness in the muscles of the great toe, which is associated with movement and balance.
Current methods used to measure the strength of the great toe muscles have several drawbacks. They are not very sensitive to changes in strength, require expensive equipment or trained professionals, and can be subjective. To address these limitations, a new portable device called ToeScale was developed. This study aims to:
- Check if the ToeScale device is a valid measure of great toe strength (GTS) in people with CIPN and how different GTS is among age- and sex- matched healthy adults.
- Explore the relationship between great toe strength and the severity of CIPN symptoms.
- Assess how easy it is for participants to use the ToeScale device.
In simpler terms, this study wants to see if the new device is reliable and accurate, how well it measures GTS in people with CIPN, and whether it's easy to use.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIPN | – | Other: No intervention (observational study)Individuals with chemotherapy-induced peripheral neuropathy with a confirmed diagnosis using the nerve conduction study |
| Healthy | – | Other: No intervention (observational study)Healthy adults with no known health conditions affecting their mobility, balance, or lower extremity muscle strength |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with CIPN and age- and sex- matched healthy controls will be recruited for this study. The recruitment will primarily rely on the resources availale through and rehabilitation specialists working within the University of Florida (UF) Health Cancer Center as well as UF Health Hospitals.
Key inclusion criteria (6 listed)
- At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe
- Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)
- Within 3 - 6 months of starting chemotherapy and a confirmed diagnosis of CIPN using the current clinical reference standard of Nerve conduction study.
- At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe
- Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)
Key exclusion criteria (4 listed)
- Comorbidities including but not limited to diabetes, arthritis, hypertension, thyroid disease, and heart disease, . that have been reported to be associated with the incidence of peripheral neuropathy and/or progression of CIPN.
- Toe deformities or impairments not caused by CIPN (including but not limited to hallux valgus/varus, hallux limitus, hallux rigidus, hammer toe deformity, claw toe, bunions, webbed toes)
- Self-reported impairment or impact on the strength of the foot, ankle, and/or great toe due to past medical or surgical history.
- Eligibility Criteria for Healthy Control group: The participants recruited for this group will be age- and sex- matched to the CIPN group
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 |
|---|---|---|
| No intervention (observational study)No intervention; observational study | Other | CIPN, Healthy |
Primary outcome
Great Toe Strength
Time frame: Baseline
Measured using the ToeScale, the novel device used in this study to evaluate both flexion and extension strength of the great toe
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)
Time frame: Baseline
This is a questionnaire that will be used to evaluate the severity of symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The scores from this questionnaire will be used to conduct a deeper analysis of the differences in great toe strength within the CIPN group.
System Usability Scale (SUS) Questionnaire
Time frame: Baseline
This questionnaire will be administered at the end of the study visit, once the participants have a chance to use the device independently to evaluate their perspective on the satisfaction, ease of use, and comfort of the device.
4 secondary outcomes
Gait analysis
Time frame: Baseline
Balance Assessment
Time frame: Baseline
Timed Up and Go (TUG)
Time frame: Baseline
Feedback ineterview
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The de-identified data might be shared with permission from the funder and PI per request and as appropriate.
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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.
Raghuveer Chandrashekhar, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy (CIPN) and Healthy, run by University of 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 6 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongwu Wang, PhD (+1 (352) 273-9934, hongwu.wang@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Great Toe Strength (time frame: Baseline). The study lists 3 primary outcomes in all. 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 3 Nov 2026.