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Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy
Trial Status: active
This is a prospective randomized trial designed to investigate a new care model for
patients who suffer from nerve damage from chemotherapy called chemotherapy induced
peripheral neuropathy (CIPN). All participants in the study will report their CIPN
symptoms daily using a website, app or phone for 12 weeks. In one group the data will be
collected and participants will be encouraged to reach out to their treating doctors for
uncontrolled symptoms. These participants' doctors can prescribe any treatment they feel
is appropriate. In the second group, if the symptoms meet the criteria for eligibility
they will receive a phone call from a nurse practitioner either the same day or next day,
depending on the time symptoms were logged. That nurse practitioner will determine the
correct CIPN treatment using an algorithm and prescribe it. The study will track the
severity of symptoms over time as well as looking at the impact on treatments for CIPN
(medications and referrals).
Inclusion Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Age ≥ 18.
2. Completion of taxane, platinum, vinca alkaloid-based chemotherapy, bortezomib,
thalidomide, lenalidomide, ixazomib, or brentuximab vedotin for cancer in the last
540 days, or ongoing maintenance therapy with bortezomib, thalidomide, lenalidomide
or ixazomib for > 90 days.
3. Development of CIPN during or within 3 months of the most recently completed
chemotherapy or previous neurotoxic chemotherapy for the same malignancy. For
patients on ongoing maintenance therapy: Development of CIPN during current
neurotoxic chemotherapy with bortezomib, thalidomide, lenalidomide, ixazomib
brentuximab vendotin or vincristine. CIPN diagnosis will be based on clinical
diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy
including the upper and lower extremities.
The Toronto Criteria for Probable Distal Symmetric Polyneuropathy is defined as a
combination of symptoms and signs of neuropathy including:
1. At least 1 (one) of the following neuropathic symptoms: "asleep numbness",
prickling or stabbing, burning or aching pain AND
2. At least 1 (one) of the following: decreased distal sensation, or unequivocally
decreased or absent ankle reflexes. (59)
Clinical Diagnosis:
a. Confirmation of CIPN diagnosis by CIPN expert (investigator/co-infestigator based
on chart review +/- inperson/virtual interview with examination).
4. Presence of at least one positive neuropathic sensory symptom on the NTSS-6 ranked
as moderate or severe on the day of screening or in the preceding week based on
recall.
5. The ability to speak/ read sufficient English to be able to communicate with study
NP over the phone, utilize the App, website and phone tree (all of which are only
available in English).
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Expected treatment with another neurotoxic chemotherapy within the 13 week overall
study duration (For example, platinum, taxane, vinca alkaloid, thalidomide,
brentuximab vedotin or related drug, or arsenic trioxide. This exclusion does not
apply to continuation of treatment for patients on maintenance therapy as described
in the inclusion criteria).
2. Presence of a neurological problem that would confound CIPN assessment (lumbar or
cervical radiculopathy, or pre-existing neuropathy from another cause such as
diabetes).
3. Currently receiving treatment at a pain clinic specifically for CIPN pain.
4. Concurrent participation in a different CIPN or pain treatment trial.
5. For women of childbearing potential: Current pregnancy
6. For women of childbearing potential: Unwillingness to use and acceptable form of
birth control for the duration of the study. Acceptable forms of birth control
include long acting implantable contraception (ie IUDs, Nexplanon), Oral
contraception pills, contraception injections, or strict abstinence if it is part of
the subject's current lifestyle.
Additional locations may be listed on ClinicalTrials.gov for NCT04763356.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
Virginia
Richmond
VCU Massey Comprehensive Cancer Center
Status: Active
Name Not Available
This is a prospective single blinded (outcome assessor) randomized controlled trial of a
CIPN care model that pairs a personalized suite of remote symptom monitoring technologies
with triggered real time responses from a nurse practitioner (NP) equipped to enact
algorithmic guideline based CIPN treatment in response to poorly controlled symptoms. The
study will enroll adult cancer patients who have, within the last 540 days, completed a
course of a taxane, platinum, or vinca alkaloid-based agent, bortezomib, thalidomide,
lenalidomide, ixazomib or brentuximab vedotin, or have been receiving ongoing maintenance
therapy with bortezomib, thalidomide, lenalidomide or ixazomib for >90 days, and have
been diagnosed with CIPN. Participants will log neuropathy symptoms daily for a one week
run-in period using a remote symptom monitoring technology described below. Participants
who meet the criteria to proceed in the study will be randomized in a 1:1 ratio to Usual
Care (UC) or Symptom Care at Home with Nurse Practitioner follow up (SCH-NP). Those not
meeting eligibility criteria will be excluded but can be rescreened 6 weeks later. Both
groups will log symptoms daily and receive either UC or SCH-NP care for the 12 week study
period.
The UC group will report daily neuropathy symptoms via the web, app or automated phone
system and will receive usual care for CIPN symptoms from their existing treatment team.
The SCH-NP group will report symptoms similarly but concerning symptoms will trigger a
call back from a nurse practitioner who can provide treatment based on standardized
algorithmic CIPN guidelines.
In person study visits will take place at baseline and 6 and 12 weeks after
randomization. CIPN specific QoL and disability measures, validated CIPN sign scales and
detailed information on opioids, neuropathic pain medications and other CIPN treatments
will be collected at each visit.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Vermont and State Agricultural College