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Remote Monitoring and Management for Chemotherapy-Induced Peripheral Neuropathy (REMOTE-CIPN Trial)

N/A

Recruiting

Led By Noah A Kolb, MD

Research Sponsored by University of Vermont

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Development of CIPN during or within 3 months of the most recently completed chemotherapy based on clinical diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy

Completion of specific chemotherapy for cancer in the last 540 days

Must not have

Intractable cancer pain requiring treatment by a pain clinic

Presence of a neurological problem that would confound CIPN assessment (lumbar or cervical radiculopathy, or pre-existing neuropathy from another cause such as diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two ways of treating CIPN: one involves daily symptom tracking and reaching out to doctors, the other involves a nurse practitioner prescribing treatment using an algorithm.

Who is the study for?

This trial is for adults who finished certain cancer chemotherapies within the last 540 days and developed nerve damage (CIPN) from it. They must speak/read English to use the study tools and not be pregnant or planning another neurotoxic chemotherapy soon. People with other neurological issues or intractable pain, on birth control they're unwilling to change, or in another CIPN/pain study can't join.

What is being tested?

The trial tests a new care model for managing chemotherapy-induced nerve damage symptoms. Participants report their symptoms daily for 12 weeks using digital tools. One group's doctors manage their care as usual, while the other gets prompt NP calls based on an algorithm to prescribe treatment.

What are the potential side effects?

Since this trial focuses on monitoring and management rather than a specific medication, side effects are related to individual treatments prescribed by participants' healthcare providers or nurse practitioners following an algorithm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I developed nerve pain or tingling after my recent chemotherapy.

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I finished my cancer chemotherapy within the last 540 days.

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I have had moderate to severe nerve pain or sensation changes recently.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe cancer pain that needs treatment from a pain clinic.

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I do not have nerve problems from other conditions that could affect nerve damage assessments.

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I agree to use effective birth control during the study.

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I will not be treated with neurotoxic chemotherapy during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in NTSS-6 between the run-in and the 12 week study period.

Secondary study objectives

Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Chemotherapy Induced Peripheral Neuropathy 20 (EORTC- CIPN 20)

The % of participants taking ≥ 50 morphine milligram equivalents (MME)/ day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SCH with NP follow-up (SCH-NP)Experimental Treatment1 Intervention

Participants will report daily symptom as above. The SCH system will notify the study NP for any of the following symptoms measured by the NTSS6: aching, allodynia, burning, lancinating, numbness, and prickling that are concerning. Participants will receive a NP call back either the same day or the next day, depending on the time they reported their symptoms. The NP will follow a standardized script to elicit details about the CIPN symptoms and recommend and prescribe CIPN treatment per the treatment algorithm.

Group II: Usual Care (UC)Active Control1 Intervention

The UC group (control) models the current standard of care model. The NTSS-6 will be completed daily by participants using the SCH system. The results will not be reported to their oncology team. Participants will be counseled at study entry to contact their treating care team to manage CIPN symptoms. They will also receive a reminder to do so at the end of each reporting session. UC participants will attend all regular visits with these providers and can receive any type of treatment for their CIPN symptoms. There are no limitations on the therapies that can be prescribed, or the means by which the clinical team communicates with the participant. Treating physicians will be provided with links to the current ASCP and NCCN guidelines but will not be provided with the algorithm as this group is meant to reflect current standard medical practice.

0 / 8Eligibility criteria met