Better Options for Chronic Cancer Pain

Recruiting at 1 trial location

Overseen By Karleen F Giannitrapani, PhD MA MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must be taking: Opioids

Must not be taking: Buprenorphine, Benzodiazepines

Disqualifiers: High opioid dose, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

294 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on long-term opioid therapy and have an agreement with your current opioid prescriber to resume prescribing after the study. You cannot participate if you are on high doses of opioids, use buprenorphine, or have certain other conditions.

What data supports the effectiveness of the treatment for chronic cancer pain?

Research shows that a multidisciplinary approach, which includes optimizing opioid use and multimodal pain care, can effectively manage cancer pain for most patients, especially those with advanced disease. This approach helps improve pain control and patient satisfaction by combining different strategies beyond just increasing opioid doses. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The safety of treatments like Buprenorphine rotation, medication optimization, and opioid tapering for cancer pain is generally supported by guidelines and evidence, but there are concerns about opioid side effects and the need for careful management. ^{1 6 7 8 9}

How does the treatment Multimodal pain care differ from other treatments for chronic cancer pain?

Multimodal pain care is unique because it combines various approaches, including medications, interventional techniques, and complementary therapies, to address the complex nature of cancer pain. This personalized and comprehensive strategy aims to improve pain management by considering the patient's overall condition, rather than focusing solely on pain relief. ^{1 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Karleen F Giannitrapani, PhD MA MPH

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Maria J. Silveira, MD MA MPH

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Eligibility Criteria

This trial is for cancer survivors who have finished treatment but are still using opioids, potentially facing addiction or overdose risks. It's designed to help them find non-opioid pain relief alternatives.

Inclusion Criteria

It's been 6 months since my last major cancer treatment, but I may be on ongoing hormone or biologic therapy.

My current doctor agrees to continue prescribing opioids after the study.

I am a veteran with a history of certain cancers but have been cancer-free for 6 months.

Exclusion Criteria

I take less than 300mg of opioids daily.

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 on the multidisciplinary pain teams

I do not use buprenorphine, have an alcohol or substance use disorder, use benzodiazepines daily, get opioids from non-VA providers, or have a history of self-harm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants are randomized to either multimodal pain care or pain medication optimization for 6 months

6 months

Stage 2 Treatment

Non-respondents from Stage 1 are randomized to either buprenorphine rotation or opioid tapering for 3 months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Buprenorphine rotation
• Medication optimization
• Multimodal pain care
• Opioid tapering

Trial Overview The study tests four strategies: multimodal pain care, reducing opioid doses gradually (tapering), switching from other opioids to buprenorphine (rotation), and optimizing medications to manage chronic cancer-related pain.

Participant Groups

Group I: Multimodal pain care 9 months Experimental Treatment 1 Intervention

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

Group II: Multimodal pain care 6 months / Opioid tapering 3 months Experimental Treatment 2 Interventions

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

Group III: Medication optimization 9 months Experimental Treatment 1 Intervention

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.

Group IV: Medication optimization 6 months/ Opioid tapering 3 months Experimental Treatment 2 Interventions

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.

Group V: Medication optimization 6 months/ Buprenorphine rotation 3 months Experimental Treatment 2 Interventions

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.

Group VI: Medication optimization Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A qualitative study involving 31 participants (18 advanced cancer patients and 13 caregivers) revealed that while most individuals recognized morphine as an effective pain reliever, they also associated it with end-stage illness and potential dependence, leading to hesitance in its use.

Despite concerns, participants expressed a willingness to use morphine for pain relief, highlighting the need for educational programs to address misconceptions about opioids, which could enhance acceptance and improve pain management in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphine use for cancer pain: A strong analgesic used only at the end of life? A qualitative study on attitudes and perceptions of morphine in patients with advanced cancer and their caregivers. Ho, JFV., Yaakup, H., Low, GSH., et al.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

[The management of multimorphic cancer pain, from diagnosis to treatment]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patients with chronic pain. [2013]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Optimizing use of opiates in the management of cancer pain. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary management of cancer pain: a longitudinal retrospective study on a cohort of end-stage cancer patients. [2011]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer Pain Management: A Narrative Review of Current Concepts, Strategies, and Techniques. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The American Society of Pain and Neuroscience (ASPN) Best Practices and Guidelines for the Interventional Management of Cancer-Associated Pain. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Morphine use for cancer pain: A strong analgesic used only at the end of life? A qualitative study on attitudes and perceptions of morphine in patients with advanced cancer and their caregivers. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Complex Balance between Analgesic Efficacy, Change of Dose and Safety Profile Over Time, in Cancer Patients Treated with Opioids: Providing the Clinicians with an Evaluation Tool. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Improving pain experience in cancer patients. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Translational advances in pain and anesthesia for cancer patients. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Cancer pain control: one state's experience. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic management of cancer pain. [2005]

13. England pubmed.ncbi.nlm.nih.gov

Pain control in thoracic oncology. [2018]