NCT07009717 Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
| NCT ID | NCT07009717 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Chemotherapy-induced Peripheral Neuropathy (CIPN) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-08-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Eligibility Criteria for Chemotherapy-Induced Peripheral Neuropathy (CIPN) group: Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Inclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07009717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Chemotherapy-induced Peripheral Neuropathy (CIPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07009717 currently recruiting?
Yes, NCT07009717 is actively recruiting participants. Contact the research team at hongwu.wang@phhp.ufl.edu for enrollment information.
Where is the NCT07009717 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT07009717 clinical trial?
NCT07009717 is sponsored by University of Florida. The trial plans to enroll 30 participants.