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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights
REMOTE-CIPN Trial 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.Check my eligibility
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.See study design
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.
REMOTE-CIPN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I developed nerve pain or tingling after my recent chemotherapy.
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I finished my cancer chemotherapy within the last 540 days.
Select...
I have had moderate to severe nerve pain or sensation changes recently.
Select...
I am 18 years old or older.
REMOTE-CIPN Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in NTSS-6 between the run-in and the 12 week study period.
Secondary outcome measures
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
REMOTE-CIPN 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.
Find a Location
Who is running the clinical trial?
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,267 Total Patients Enrolled
2 Trials studying Peripheral Neuropathy
506 Patients Enrolled for Peripheral Neuropathy
Virginia Commonwealth UniversityOTHER
699 Previous Clinical Trials
22,884,623 Total Patients Enrolled
3 Trials studying Peripheral Neuropathy
61 Patients Enrolled for Peripheral Neuropathy
University of VermontLead Sponsor
267 Previous Clinical Trials
3,743,319 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your diagnosis of chemotherapy-induced peripheral neuropathy (CIPN) needs to be confirmed by a specialist who will review your medical records and may also talk to you or examine you.I developed nerve pain or tingling after my recent chemotherapy.I finished my cancer chemotherapy within the last 540 days.I have severe cancer pain that needs treatment from a pain clinic.I can speak and read English well enough to use an app, website, and communicate over the phone.I do not have nerve problems from other conditions that could affect nerve damage assessments.I have had moderate to severe nerve pain or sensation changes recently.I agree to use effective birth control during the study.I will not be treated with neurotoxic chemotherapy during the study.You are currently taking part in another trial for treating nerve pain or other types of pain.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care (UC)
- Group 2: SCH with NP follow-up (SCH-NP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it currently feasible for participants to join this investigation?
"In accordance with the details provided on clinicaltrials.gov, this medical trial is still actively searching for subjects to partake in the study - which has been documented since 16th January 2023 and was last revised 9th March 2023."
Answered by AI
What is the sample size for this research endeavor?
"To fulfill the parameters of this clinical trial, 422 individuals matching the established criteria must take part. Both University of Vermont in Burlington and Virginia Commonwealth University Massey Cancer Center in Richmond are offering opportunities for patient participation."
Answered by AI
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