Recruiting
Phase 2

Scrambler Therapy

Sponsor:

Fox Chase Cancer Center

Code:

NCT06914557

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Scrambler Therapy

Questionnaire and Physical Exam

Study Details

Brief summary:

The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications.

Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Pain

Study ID

NCT06914557

Start date

Mar 3, 2025

Status verified date

Apr, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Duloxetine Group

Patients will be treated with Duloxetine as per Specialized Outpatient Palliative Care SOPC standard neuropathy treatment protocol

active comparator: Scrambler + Duloxetine

Patients' pharmacological treatment of their CIPN (including the management of duloxetine and other co-analgesics) will follow SOPC standard neuropathy treatment protocol

Interventions

Scrambler Therapy

Scrambler therapy will be administered by the staff of the Supportive Oncology and Palliative Care team who have been trained in Scrambler therapy and have extensive experience providing it to patients with neuropathic cancer-related pain. Patients who meet the study criteria will be treated daily, Monday through Friday, for up to 10 sessions. The treatment may be terminated sooner if a patient experiences complete pain relief or if it is ineffective after five sessions. Patients will be closely monitored during the treatment. The treatment is non-painful and not associated with any significant adverse effects.

Questionnaire and Physical Exam

15-minute-long questionnaires evaluating Pain and degree of pain.

Primary outcome measure

  • The difference in the proportion with a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 with the cross-sectionally measured "average" pain score at baseline (baseline = day 1). [ Time Frame: At Day 35 ]

Central Contacts and Locations

Central contacts

Gerald Nkogbu, MBBS, MS

2157285378gerald.nkogbu@fccc.edu

Leslie Fortin, MPH

215-214-3996leslie.fortin@fccc.edu

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19123

Contacts

Marcin Chwistek, MD

215-728-3544marcin.chwistek@fccc.edu

Leslie Fortin, MPH

215-214-3996leslie.fortin@fccc.edu

Principal Investigator:

Marcin Chwistek, MD

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Keywords

  • CIPN
  • neuropathy
  • Chemotherapy-Induced Peripheral Neuropathy
  • Duloxetine
  • Scrambler Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2025-04-09.