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Duloxetine To Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study (A221805)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04137107

Background Information

Chemotherapy is a mainstay cancer treatment received by most of the nearly 14 million cancer survivors living in the United States (US) today. In 2017 in the US, most of the 135,000 people diagnosed with colorectal cancer received oxaliplatin to treat stage II-IV disease. About 70% of patients develop sensory oxaliplatin-induced peripheral neuropathy (OIPN) characterized by upper and lower extremity numbness (N) and tingling (T) that can persist for years. Painful OIPN develops after N and T in approximately 30% of patients. OIPN poses a major health risk because it is associated with impaired function, falls, depression, impaired sleep, and poor quality of life. Further, 85% of patients receiving oxaliplatin will require dosage reductions due to OIPN which may worsen survival outcomes.

This study will test whether duloxetine, a serotonin-norepinephrine reuptake inhibitor with known efficacy for established, chronically painful OIPN, will be effective to prevent the most common OIPN sensory symptoms—N, T, and pain. Duloxetine will be tested in this study based on evidence of efficacy from two clinical trials one of which was an CALGB Phase III trial (results published in JAMA 2013).

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

Eligibility Information

  • Age 25 years or older
  • Stage II-III colorectal cancer to be treated with oxaliplatin over 12 to 24 weeks
  • Additional eligibility in protocol

Ineligibility Information

  • Prior neurotoxic chemotherapy
  • Existing peripheral neuropathy
  • Symptoms or history of schizophrenia, bipolar disease, eating disorders, suicidal thoughts, and/or a major depression
  • Pregnancy/breastfeeding
  • Additional ineligibility in protocol

For additional information, please visit: https://www.clinicaltrials.gov/ct2/show/NCT04137107