Chemotherapy-Induced Peripheral NeuropathyEarly Phase 1NCT03943498
Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy
A Early Phase 1 study testing Fingolimod, Fingolimod Hydrochloride and Questionnaire Administration in people with Chemotherapy-Induced Peripheral Neuropathy and Numbness, run by Mayo Clinic at 2 sites in United States.
Trial summary
This early phase I trial studies how well fingolimod works in treating patients with chemotherapy-induced nerve pain (neuropathy). Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Numbness, Pain
- What is being tested?
- Fingolimod, Fingolimod Hydrochloride and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2019to 10 Dec 2020
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention.
- NOTE: Neurotoxic chemotherapy must have been completed >= 6 months (186 days) prior to registration and there must be no further planned neurotoxic chemotherapy for > 6 months after registration.
- Tingling, numbness or pain was at least a four out of ten problem during the week prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem (patient verbal report to clinician).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
- Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only.
- Provided written informed consent.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Life expectancy >= 6 months.
Who cannot join
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons.
- Nursing persons.
- Persons of childbearing potential who are unwilling to employ adequate contraception.
- Previous diagnosis of diabetic or other peripheral neuropathy.
- Current or previous use of fingolimod.
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- History of the following preexisting conditions: ischemic heart disease, cardiac arrest, cerebrovascular disease, uncontrolled hypertension, symptomatic bradycardia, macular edema, recurrent syncope, severe untreated sleep apnea, herpes simplex virus (HSV) varicella zoster (VZV), chronic hepatitis, tuberculosis, fungal infections, skin cancer, or diabetes.
- Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or class III/IV heart failure =< 6 months prior to registration.
- History or presence of Mobitz type II second degree or third degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker.
- History of hypersensitivity reaction to fingolimod or any of the excipients including rash, urticarial, and angioedema upon treatment initiation.
- Baseline corrected QT (QTc) interval >= 450 ms (on patient electrocardiography [EKG]).
- Concurrent use of a class Ia or III antiarrhythmic drug.
- Drugs with a known risk of torsades de pointes.
- Concurrent use of beta blockers, calcium channel blockers, or digoxin.
- Use of immunosuppressive or immune-modulating therapies that may have immunosuppressive effects.
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive.
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection.
- Unstable angina pectoris.
- Cardiac arrhythmia.
- Or psychiatric illness/social situations that would limit compliance with study requirements.
- Family history of genetic/familial neuropathy.
- Currently receiving another agent to treat CIPN, such as duloxetine, gabapentin or pregabalin, and not willing to be weaned off of these medications prior to therapy initiation.
- History of peripheral neuropathy prior to receiving neurotoxic chemotherapy.
- Received a vaccine (inactivated) =< 2 weeks prior to registration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43212
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Treatment of Established Chemotherapy-Induced Neuropathy With Fingolimod: A Pilot Trial
This early phase I trial studies how well fingolimod works in treating patients with chemotherapy-induced nerve pain (neuropathy). Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate whether fingolimod markedly improves symptoms in patients with established (chemotherapy-induced peripheral neuropathy) CIPN.
II. To evaluate the tolerability of fingolimod in these treated patients.
OUTLINE:
Patients receive fingolimod orally (PO) once daily (QD) for 4 weeks.
After completion of study treatment, patients are followed up every month for 3 months.
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Numbness, Pain, Tingling
- Being tested
- Fingolimod, Fingolimod Hydrochloride, Questionnaire Administration
- Medical subject headings
- Hypesthesia, Pain, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Given PO daily for 4 weeks
Fingolimod HydrochlorideDrug
Also called FTY-720, FTY720, Gilenya
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Fingolimod) | Experimental | Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks.
Take your Fingolimod approximately every 24 hours Receives: Drug: Fingolimod; Drug: Fingolimod Hydrochloride; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serially measured total sensory neuropathy scores
Will be obtained from the 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). The hypothesis will be tested with the two-sided one-sample t-test at a significance level of 10% reduction. In the event that the distribution of the within-patients change from baseline in total sensory neuropathy scores is not approximately normally distributed, then variable transformation or a nonparametric one-sample Wilcoxon signed-rank test will be considered as alternative approaches.
Measured: Baseline up to 3 months post treatment
Secondary outcomes (1)
Incidence of adverse events (AEs) of fingolimod
The constellation of AEs as scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) will be summarized by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles, the maximum grade for each type of AE are recorded for each patient and data listings and frequency tables are clinically reviewed to determine overall patterns, including AE attribution (possible, probable, and definite) to fingolimod. Sensory neuropathy will be graded as none, mild, moderate, and severe. The percentage of patients experiencing an improvement in sensory neuropathy from baseline using NCI CTCAE v5.0 will be calculated with the exact 90% confidence interval.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start24 May 2019
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles L Loprinzi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943498
- Sponsor's protocol ID
- MC18C2
- Other IDs
- NCI-2019-02742, MC18C2, P30CA015083
- Status last verified
- Sep 2023
- First submitted
- 7 May 2019
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Established Chemotherapy-Induced Neuropathy With Fingolimod: A Pilot Trial
- ClinicalTrials.gov ID
- NCT03943498
- Acronym / sponsor ID
- MC18C2
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Numbness, Pain, Tingling
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 9 May 2019 (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 early phase I trial studies how well fingolimod works in treating patients with chemotherapy-induced nerve pain (neuropathy). Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate whether fingolimod markedly improves symptoms in patients with established (chemotherapy-induced peripheral neuropathy) CIPN.
II. To evaluate the tolerability of fingolimod in these treated patients.
OUTLINE:
Patients receive fingolimod orally (PO) once daily (QD) for 4 weeks.
After completion of study treatment, patients are followed up every month for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Fingolimod) | Experimental | Drug: Fingolimod, Drug: Fingolimod Hydrochloride, Other: Questionnaire AdministrationPatients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks. Take your Fingolimod approximately every 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention.
- Tingling, numbness or pain was at least a four out of ten problem during the week prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem (patient verbal report to clinician).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
- Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only.
- Provided written informed consent.
Key exclusion criteria (25 listed)
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Previous diagnosis of diabetic or other peripheral neuropathy.
- Current or previous use of fingolimod.
- History of the following preexisting conditions: ischemic heart disease, cardiac arrest, cerebrovascular disease, uncontrolled hypertension, symptomatic bradycardia, macular edema, recurrent syncope, severe untreated sleep apnea, herpes simplex virus (HSV) varicella zoster (VZV), chronic hepatitis, tuberculosis, fungal infections, skin cancer, or diabetes.
- Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or class III/IV heart failure =< 6 months prior to registration.
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 |
|---|---|---|
| FingolimodGiven PO daily for 4 weeks | Drug | Treatment (Fingolimod) |
| Fingolimod HydrochlorideAlso: FTY-720, FTY720, GilenyaGiven PO | Drug | Treatment (Fingolimod) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (Fingolimod) |
Primary outcome
Serially measured total sensory neuropathy scores
Time frame: Baseline up to 3 months post treatment
Will be obtained from the 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). The hypothesis will be tested with the two-sided one-sample t-test at a significance level of 10% reduction. In the event that the distribution of the within-patients change from baseline in total sensory neuropathy scores is not approximately normally distributed, then variable transformation or a nonparametric one-sample Wilcoxon signed-rank test will be considered as alternative approaches.
1 secondary outcome
Incidence of adverse events (AEs) of fingolimod
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
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Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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.
Charles L Loprinzi principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fingolimod, Fingolimod Hydrochloride and Questionnaire Administration in people with Chemotherapy-Induced Peripheral Neuropathy and Numbness, run by Mayo Clinic at 2 sites 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 8 inclusion and 25 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: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serially measured total sensory neuropathy scores (time frame: Baseline up to 3 months post treatment). 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 11 Sep 2023.