Using Scrambler Therapy with Duloxetine for Chemotherapy-Induced Peripheral Neuropathy

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 clinical trial investigates the effectiveness of Scrambler therapy combined with duloxetine compared to duloxetine alone in treating chemotherapy-induced peripheral neuropathy (CIPN). The study aims to determine if this combination can achieve a significant reduction in pain scores after 35 days of treatment. Participants will be assessed using various pain and function measurement tools, including the Brief Pain Inventory-Short Form and the EORTC CIPN-20. The trial focuses on patients who have experienced neuropathy as a side effect of chemotherapy and are currently on duloxetine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Persons aged 18 years or older with cancer
2. Eastern Cooperative Oncology Group 0-2
3. At least a 4/10 average pain score prior to treatment
4. At least CTCAE version 5.0 grade 2 neuropathies.
5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.
6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
7. Patients must have discontinued neurotoxic chemotherapy within the last 3 months with no additional therapy planned for the next 6 months after initiation of CIPN treatment.
8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation
9. Patients must be able to provide informed written consent.

Exclusion Criteria:

1. Children or adolescents
2. Pregnant or nursing patients
3. Presence of an implantable life supporting medical device or implantable drug delivery system
4. Patients with severe skin conditions preventing the proper application of electrodes
5. Patients currently on monoamine oxidase inhibitors MAOIs.
6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).
7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)
8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed
9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder
10. Patients with uncontrolled epilepsy.
11. Patients who have previously attempted or undergone Scrambler therapy.

Where it's running

• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Marcin Chwistek, MD — Fox Chase Cancer Center
• Study coordinator: Gerald Nkogbu, MBBS, MS
• Email: gerald.nkogbu@fccc.edu
• Phone: 2157285378

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

• Hyperbaric oxygen therapy for nab-paclitaxel-induced neuropathy in breast cancer

  This study tests whether hyperbaric oxygen therapy can help relieve neuropathy from nab-paclitaxel in adult women with breast cancer who have finished chemotherapy.

  Recruiting at 2 sites Phase 2/3 Guangdong Provincial People's Hospital · Guangzhou, Guangdong and 1 other locations · NCT07410169

• Scrambler Therapy for chemotherapy-related nerve pain (CIPN).

  Researchers will try Scrambler Therapy, a non-drug electrical treatment, to reduce pain and numbness in people with long-lasting chemotherapy-induced peripheral neuropathy.

  Recruiting Case Comprehensive Cancer Center · Cleveland, Ohio · NCT07219472

• VMD-3866 topical gel for chemotherapy-induced nerve pain

  This trial will test whether a non-opioid topical gel called VMD-3866 can reduce pain in adults with chemotherapy-induced peripheral neuropathy.

  Recruiting Phase 2 VM Therapeutics LLC · London, UK · NCT07072468

• Cryocompression to prevent taxane-induced nerve damage in the arms and legs.

  This study tests whether cooling and pressure applied to the arms and legs during taxane chemotherapy can prevent or reduce numbness, pain, or weakness from peripheral neuropathy in adults with breast or gynecologic cancer.

  Recruiting Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07064798

• Explicit Sensory Retraining for Chemo-Induced Peripheral Neuropathy

  This study tests whether three sessions of explicit sensory retraining for the legs, compared with usual care, can help reduce symptoms and improve function in adults with CIPN after chemotherapy.

  Recruiting Assaf-Harofeh Medical Center · Tzrifin · NCT06724861

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.