Better Options for Chronic Cancer Pain

NCT06574009 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: NURP-004-24SI01CX002902-01
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 2

Brief Summary

This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.

Conditions

Chronic Pain; Cancer Survivor; Opioid Dependence

Keywords

survivorship; chronic pain; analgesics

Outcome Measures

Primary Outcomes (1)

• Opioid dose reduction + Pain response (binary: yes/no)

  The primary outcome is a composite variable which combines one objective outcome (opioid dose reduction) and one subjective outcome (pain interference) to reflect two outcomes of equal importance to Veterans. Veterans will be considered as achieving this outcome if they experience 20% reduction in opioid daily dose (in MEDD) from baseline and no worsening of pain interference by more than 1 point on the Pain Enjoyment of Life and General Activity (PEG) score.

  9 months

Secondary Outcomes (3)

• Opioid dose

  9 months

• Pain interference

  9 months

• Pain intensity

  9 months

Study Arms (6)

Multimodal pain care 9 months

EXPERIMENTAL

Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration

Behavioral: Multimodal pain care

Medication optimization

EXPERIMENTAL

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan.

Behavioral: Multimodal pain care; Device: Buprenorphine rotation

Multimodal pain care 6 months / Opioid tapering 3 months

EXPERIMENTAL

Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration. After 6 mo, subjects will attempt to taper opioids

Behavioral: Multimodal pain care; Other: Opioid tapering

Medication optimization 9 months

EXPERIMENTAL

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain.

Drug: Medication optimization

Medication optimization 6 months/ Buprenorphine rotation 3 months

EXPERIMENTAL

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will receive buprenorphine and attempt to taper opioids for following 3 mo.

Drug: Medication optimization; Device: Buprenorphine rotation

Medication optimization 6 months/ Opioid tapering 3 months

EXPERIMENTAL

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will attempt to taper opioids for following 3 mo.

Drug: Medication optimization; Other: Opioid tapering

Interventions

Multimodal pain care BEHAVIORAL

Behavioral therapy (as below), physical therapy, assistive devices (e.g. TENS, bracing), referrals to VA specialists (e.g. interventional pain), and complementary and integrative therapies (e.g. acupuncture or massage

Medication optimization; Multimodal pain care 6 months / Opioid tapering 3 months; Multimodal pain care 9 months

Medication optimization DRUG

Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain.

Medication optimization 6 months/ Buprenorphine rotation 3 months; Medication optimization 6 months/ Opioid tapering 3 months; Medication optimization 9 months

Buprenorphine rotation DEVICE

Subjects randomized to this arm at 6 months will be offered the chance to rotate from their full mu agonist opioid to buprenorphine using a standardized protocol

Medication optimization; Medication optimization 6 months/ Buprenorphine rotation 3 months

Opioid tapering OTHER

Subjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide

Medication optimization 6 months/ Opioid tapering 3 months; Multimodal pain care 6 months / Opioid tapering 3 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

NOT YET RECRUITING

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karleen F Giannitrapani, PhD MA MPH

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

• Maria J Silveira, MD MA MPH

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria J Silveira, MD MA MPH

CONTACT

(734) 845-3502; Maria.Silveira2@va.gov

Matthew D McCaa, MS OTR

CONTACT

(650) 493-5000; matthew.mccaa@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: October 7, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)