Threshold Tracking for Nerve Damage

Not yet recruiting at 1 trial location

Overseen By Ka-Wai Ho, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ka-Wai Ho

Disqualifiers: Pre-existing neuropathy, Genetic neuropathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how nerves react in individuals with nerve damage caused by the cancer drug cisplatin. Researchers aim to understand how these nerve problems develop and identify early signs of nerve damage in those receiving this treatment. The trial includes two groups: one for individuals starting cisplatin treatment without nerve issues and another for those already experiencing nerve damage from the drug. Individuals beginning or having completed cisplatin chemotherapy who have experienced nerve problems like tingling or numbness might be suitable for this study.

As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance early detection and management of nerve damage in cancer patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that threshold tracking nerve conduction studies are safe for evaluating nerve excitability?

Research has shown that cisplatin, a common chemotherapy drug, often causes peripheral neuropathy, a type of nerve damage that can make hands and feet feel numb or tingly. Studies have found this side effect occurs in about 60% of patients receiving certain doses of cisplatin. The risk of nerve damage increases with higher doses. Cisplatin can also cause other side effects, such as hearing loss and kidney problems. Despite these risks, cisplatin remains an approved cancer treatment, as its benefits can outweigh its risks for many patients. Anyone considering cisplatin should discuss potential side effects with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Threshold Tracking for Nerve Damage trial because it aims to better understand and potentially predict cisplatin-induced peripheral neuropathy (cis-PN). Cisplatin, a chemotherapy drug, can cause nerve damage in some patients, leading to significant discomfort and quality of life issues. This trial is unique because it uses threshold tracking, which involves detailed neurological exams and conduction studies, to monitor nerve health before, during, and after treatment. By identifying early signs of nerve damage, researchers hope to develop strategies to prevent or mitigate cis-PN, improving patient care and outcomes.

What evidence suggests that threshold tracking nerve conduction studies are effective for evaluating nerve damage in cisplatin-induced peripheral neuropathy?

Research has shown that cisplatin, a potent chemotherapy drug, has significantly improved cancer survival rates. However, it often causes peripheral neuropathy, a side effect involving nerve damage that results in pain, tingling, or numbness, affecting over 80% of patients. Studies in mice have demonstrated a clear decrease in nerve signals when treated with cisplatin, mirroring effects seen in humans. Although no method currently exists to completely prevent this nerve damage, understanding cisplatin's impact on nerves can aid in developing strategies to better manage or predict these side effects. This trial will include two cohorts: one without cisplatin-induced peripheral neuropathy and another with it. The study examines nerve activity to identify early signs of nerve damage in individuals receiving cisplatin treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Ka-Wai Ho, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Tamar Berger, MD PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals experiencing nerve damage, specifically peripheral neuropathy, as a result of cisplatin chemotherapy. It aims to understand the underlying mechanisms and find early signs of nerve toxicity.

Inclusion Criteria

* Adults age ≥ 18 who will begin cisplatin-based chemotherapy either alone or in combination with other agents that are not known to cause neuropathy.

* Participants must have adequate hematologic parameters to allow chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline visit with neurological exams and conduction studies

1 week

1 visit (in-person)

Treatment

Participants receive standard of care chemotherapy infusion and undergo post-infusion study visits

24 weeks

Multiple visits (phone and in-person, number varies)

End of Treatment

7-day end of treatment visit via phone call

1 week

1 visit (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 1-month post-treatment visit with neurological exams and conduction studies

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin

Trial Overview The study tests how nerves respond using threshold tracking nerve conduction studies (TTNCS) in patients with cisplatin-induced neuropathy to potentially identify early markers of neurotoxicity.

How Is the Trial Designed?

Group I: Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy Experimental Treatment 1 Intervention

30 participants with cis-PN symptoms will be enrolled and will complete the following: -One-time visit with neurological exams and conduction studies

Group II: Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy Experimental Treatment 1 Intervention

30 participants with no baseline neuropathy symptoms will be enrolled prior to starting cisplatin-based chemotherapy and will complete the following: * Baseline visit with neurological exams and conduction studies * Standard of care chemotherapy infusion (duration may vary depending on the chemotherapy regimen received) * Post-Infusion study visits via phone call (number of visits may vary depending on the chemotherapy regimen received) * In-clinic visit with neurological exams and conduction studies if participants develop cis-PN symptoms --If participants do not develop cis-PN symptoms, participants will be reevaluated 1 month post end of cisplatin treatment * 7-day end of treatment visit via phone call * 1-month post-treatment visit with neurological exams and conduction studies

Who Is Running the Clinical Trial?

Ka-Wai Ho

Lead Sponsor

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7850121/

Cisplatin-induced peripheral neuropathy is associated with ... Mice treated with cisplatin experienced a significant progressive decrease in the amplitudes of SNAPs recorded in the digital nerves (Figure 1B). Similarly, the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0278691519308695

Overview of cisplatin-induced neurotoxicity and ototoxicity, ... Cisplatin has dramatically improved the survival rate of cancer patients, but it has also increased the prevalence of hearing and neurological deficits in ...

3. ascopubs.org ascopubs.org/doi/10.1200/JGO.19.00097

Prevalence and Predictors of Cisplatin-Induced Peripheral ... Fifty-six patients (83.6%) had peripheral neuropathy. Forty-five patients (81%) had mild-grade (grades 1 and 2) peripheral neuropathy. Only two ...

4. nature.com nature.com/articles/s41598-020-71042-6

Depletion of senescent-like neuronal cells alleviates ... We showed that cisplatin induces peripheral neuropathy, as confirmed by mechanical and thermal pain assessment, and was associated with the ...

5. cochrane.org cochrane.org/evidence/CD005228_interventions-preventing-nerve-damage-caused-cisplatin-and-other-tumour-inhibiting-platinum-drugs

Interventions for preventing nerve damage caused by ... In all, this review includes data from 2906 participants. However, only seven trials reported data for the primary outcome measure of this ...

6. frontiersin.org frontiersin.org/journals/molecular-neuroscience/articles/10.3389/fnmol.2017.00174/full

Pathophysiology of Chemotherapy-Induced Peripheral ... Cisplatin causes a wide range of side effects including ototoxicity (hearing loss and tinnitus), nephrotoxicity, myelotoxicity and neuropathy. One of the most ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3964029/

Chemotherapy-induced peripheral neuropathy in adults For cisplatin, evidence of peripheral nerve damage of any grade has been reported in about 60% of patients receiving a total cumulative drug dose ranging from ...