sing functional magnetic resonance imaging to investigate the efficacy of menthol in chemotherapy induced peripheral neuropathy (CIPN): a pilot exploratory study

Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)0 sites32 target enrollmentSeptember 23, 2013

ConditionsChemotherapy Induced Peripheral Neuropathy (CIPN)Cancer

Overview

Phase: 未知
Intervention: Not specified
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Sponsor: Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)
Enrollment: 32
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 23, 2013

End Date

November 3, 2014

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)

Eligibility Criteria

Inclusion Criteria

•1\. Patients have received any neurotoxic chemotherapy.
•2\. Patients have experienced post treatment chemotherapy induced peripheral neuropathy (CIPN) pain for a minimum of 3 months.?
•3\. Patients reporting a distressing or uncomfortable neuropathic symptom (such as pain or tingling) with a score of \=4 on a scale of 0\-10 with 0 being none.
•4\. Male and female aged 18 years or over at study entry.
•5\. Patient?s Oncology team agrees to their taking part in the study.
•6\. Patients are able to provide written informed consent to participation in the study after explanation of the study protocol.
•7\. Patients have the ability to complete questionnaire assessments in English language.
•8\. In the opinion of the investigator, the patient is able to complete the various assessments.
•9\. Neuropathy must be confined to the distal extremities (distal to elbows and/or knees).

Exclusion Criteria

•1\. Preexisting or history of peripheral neuropathy due to any cause other than chemotherapy (diabetes, alcohol, toxin, hereditary, etc).?
•2\. Patients with any contraindication to the use of topical therapy or menthol.
•3\. Neurological conditions which may influence findings (such as multiple sclerosis or residual signs/symptoms from a previous stroke).
•4\. Skin conditions which prevent assessment of the relevant areas affected by peripheral neuropathy.
•5\. Suffering from significant psychiatric illness, which would hinder their completion of the study.
•6\. General medical condition is unstable or rapidly deteriorating, such that they are unlikely to be able to contribute to the study.
•7\. In the opinion of the Research Team or their usual medical team, would be unable to complete the study protocol for any other reason.
•8\. Current treatment of \= 30 days duration with anticonvulsants, tricyclic antidepressants, monoamine oxidase (MAO) inhibitor, or other neuropathic pain medication agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine or amifostine. (If on a stable dose of any of these medications for \>31 days, patients will be asked to continue these for the duration of the study. Analgesic agents such as acetaminophen, nonsteroidal anti\-inflammatory agents, or opioids, are allowed).
•9\. Application of topical lidocaine patch/gel or capsaicin cream or patch (to the limb extremities) currently or within the last 30 days (as this would interfere with application of the menthol cream and potentially study outcome).
•10\. Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.