This phase II trial compares the effect of Scrambler therapy with duloxetine-based usual care to duloxetine-based usual care alone in treating patients with chemotherapy induced peripheral neuropathy (CIPN). Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Neuropathy may be caused by physical injury, infection, toxic substances, disease (such as cancer, diabetes, kidney failure, or malnutrition), or drugs, including anticancer drugs. Scrambler therapy is a type of treatment for nerve pain that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain. Duloxetine is a drug used to treat depression and peripheral neuropathy that can occur with diabetes. It is also being studied in the treatment of peripheral neuropathy caused by certain anticancer drugs. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. It is a type of serotonin and norepinephrine reuptake inhibitor. Giving Scrambler therapy with duloxetine-based usual care may be more effective compared to duloxetine-based usual care alone in improving pain related to CIPN.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06914557.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Fox Chase Cancer CenterStatus: Active
Contact: Marcin A Chwistek
Phone: 215-728-4300
PRIMARY OBJECTIVE:
I. Investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in patient achievement of at least 50% reduction in pain scores when comparing the cross-sectionally measured “average” pain score (question 5 on the Brief Pain Inventory [BPI]) at day 35 to cross-sectionally measured “average” pain score at baseline (baseline = day 1).
SECONDARY OBJECTIVES:
I. Investigate the proportion of patients in each arm who achieve at least 30% reduction in their cross-sectionally measured “average” pain score on the BPI from baseline (day 1) to day 35 and day 1 to day 56.
II. Investigate the effectiveness of Scrambler therapy on groups stratified by receipt of neurotoxic cancer therapeutic agent given prior to study enrollment based on changes to “average pain score” on BPI from day 1 to day 35 and day 1 to day 56.
III. Compare the change in average daily oral morphine requirements (i.e. dosage) by treatment arm from day 1 to day 35 and day 1 to day 56.
IV. Investigate the proportion of patients in each arm who achieve at least 50% improvement in Pain Disability Questionnaire (PDQ) score from day 1 to day 35 and day 1 to day 56.
EXPLORATORY OBJECTIVES:
I. Examine whether the proportion of patients who achieve at least 50% reduction in their pain scores at the end of day 35 after receiving both Scrambler therapy and duloxetine differs between those randomized to the Scrambler therapy arm versus those in duloxetine-based usual care arm who decide to cross-over to the Scrambler therapy arm.
II. Investigate the proportion of patients between arms with at least 50% improvement in European Organization for Research and Treatment of Cancer (EORTC) score from day 1 to day 35 and day 1 to day 56.
III. Investigate the percentage of patients in the Scrambler arm who maintain at least 50% improvement in EORTC score at day 180.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care duloxetine orally (PO) once daily (QD) for 56 days in the absence of disease progression or unacceptable toxicity. At completion of 56 days, patients may cross-over to Arm II.
ARM II: Patients receive standard of care duloxetine PO QD for 180 days in the absence of disease progression or unacceptable toxicity. Patients also undergo Scrambler therapy sessions over 30 minutes on Monday-Friday for up to 10 sessions.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorMarcin A Chwistek
