Remote monitoring and management of nerve damage from chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates a new care model for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN). Participants will report their symptoms daily using a website, app, or phone for 12 weeks. They will be randomized into two groups: one receiving usual care and the other receiving enhanced care with follow-up from a nurse practitioner who will provide treatment based on an algorithm. The study aims to track symptom severity and treatment effectiveness over time.

Why it matters

Who can join: the full rules

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 or ongoing survival, palliative or equivalent therapy with any of the above listed drugs 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.

Where it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting
• University of Vermont
  Burlington, Vermont, United States Recruiting
• Virginia Commonwealth University Massey Cancer Center
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Noah A Kolb, MD — University of Vermont
• Study coordinator: Noah A Kolb, MD
• Email: noah.kolb@uvmhealth.org
• Phone: 802-847-4589

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling

  This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.

  Recruiting at 3 sites Azienda Sanitaria dell'Alto Adige · Bolzano, Bolzano and 3 other locations · NCT07780955

• SIR2501 plus Paclitaxel for solid tumors

  This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.

  Recruiting at 3 sites Phase 2 Sironax USA, Inc. · Hollywood, Florida and 4 other locations · NCT07765446

• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

  This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07673614

• Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy

  Researchers are testing a small, at-home device that you wear on the ear to see if it eases nerve pain from chemotherapy.

  Recruiting University of Miami · Coral Gables, Florida · NCT07596030

• Blood extracellular vesicles to detect chemotherapy-related nerve damage.

  We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07558447

• Virtual LASO-3 diet program to ease chemotherapy-related numbness and tingling

  This trial tests whether a virtual diet program that lowers added sugar and increases fiber and omega-3s can help cancer survivors who have numbness, tingling, or pain after neurotoxic chemotherapy.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07365007

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.