Better Options for Chronic Cancer Pain
Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 23, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Better Options for Chronic Cancer Pain," is designed to find safer alternatives for cancer survivors who are still using opioids to manage their chronic pain after completing cancer treatment. Many veterans who have survived cancer continue to rely on opioid medications, which can lead to addiction and other health risks. The study will test four different methods to help reduce opioid use and improve pain management for these individuals, aiming to provide better support and treatment options.
To participate in the trial, veterans must have had certain types of cancer (like breast, lung, or prostate) and have been cancer-free for at least six months. They should also be experiencing moderate to severe pain and have been using opioids regularly. Participants can expect to receive care focused on managing their pain without increasing their risk for addiction. It's important to note that this study is not yet recruiting participants, but it aims to make a significant impact on how pain is managed among cancer survivors in the Veterans Health Administration.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of active disease for at least 6 months
- • Participants must be 6 months away from their last receipt of cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies needed to sustain remission or cancer control.
- * Participants must report pain \>=4 (on 0-10 NRS) on their last 3 recordings in the electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT) defined as:
- • a qualifying opioid analgesic dispensed within the prior 30 days
- • plus 150 days' supply of a qualifying opioid (fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone) in the 180 days before the most recent dispensing date with no between-fill gaps \>40 days
- • There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study
- Exclusion Criteria:
- • Veterans with total daily opioid doses \>= 300 Morphine Milligram Equivalents (MME) will be excluded (higher doses require tapering prior to rotation to buprenorphine, which is something the investigators do not want to examine in this study)
- • Veterans with referrals or visits to a substance abuse clinic within the prior 2 years will be excluded to avoid including individuals requiring addiction expertise that is not available one the multidisciplinary pain teams
- * The investigators will also exclude Veterans with:
- • current or past use of buprenorphine
- • active alcohol use disorder or substance use
- • risk factors for opioid overdose (e.g. active suicidality or history of self-directed violence)
- • daily use of benzodiazepines
- • receipt of opioids from non-VA providers in the prior 3 months
- • or aberrant urine drug screen at baseline (cannabis is not exclusionary)
- • To ensure the relevance of our work to as many Veteran cancer survivors as possible, the investigators will not exclude subjects meeting DSM criteria for opioid use disorder if their only source of opioids is the VA
About Va Office Of Research And Development
The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Ann Arbor, Michigan, United States
Patients applied
Trial Officials
Maria J. Silveira, MD MA MPH
Principal Investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Karleen F Giannitrapani, PhD MA MPH
Principal Investigator
VA Palo Alto Health Care System, Palo Alto, CA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported