294 Participants Needed

Better Options for Chronic Cancer Pain

Recruiting at 1 trial location
VD
MJ
KF
Overseen ByKarleen F Giannitrapani, PhD MA MPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: VA Office of Research and Development
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help cancer survivors manage chronic pain without relying on opioids. It tests various treatment plans, including medication adjustments and multimodal pain care (a combination of different therapies), to determine which best reduces opioid use. The focus is on veterans who have overcome cancer but still experience significant pain and are on long-term opioid therapy. Veterans who have been cancer-free for at least six months and continue to suffer from frequent, severe pain while using opioids would be suitable candidates for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering veterans the opportunity to benefit from established therapies.

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 is the safety track record for these treatments?

Research has shown that the treatments under study for improving pain relief in cancer survivors have been safe in previous studies.

For those considering multiple methods for pain care, earlier research has found that these approaches help people use pain medications safely and improve pain relief without major side effects. This often results in better pain management with fewer problems.

Adjusting and fine-tuning different pain medications, known as medication optimization, has also been shown to be generally safe. Studies have found it effective in managing pain, with serious side effects being rare.

Switching from other opioids to buprenorphine, known as buprenorphine rotation, has been linked to lower pain levels. Existing data indicates it usually does not cause withdrawal symptoms or other major health issues.

Gradually reducing opioid use, known as opioid tapering, can sometimes cause withdrawal symptoms or increased pain. However, some patients report better function and quality of life after tapering. Research suggests that careful monitoring can help manage these risks.

Overall, these treatments have been studied for safety in various settings and are generally well-tolerated.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these multimodal pain care treatments for chronic cancer pain because they offer a more personalized approach than standard options like opioids or non-opioid medications alone. These treatments combine medication optimization with personalized care plans crafted by a team physician and the patient, potentially enhancing effectiveness and reducing reliance on opioids. Some plans include opioid tapering or buprenorphine rotation, which could help manage pain with fewer side effects and lower addiction risk. By addressing pain from multiple angles and incorporating patient collaboration, these treatments aim to provide more comprehensive relief and improve overall quality of life.

What evidence suggests that this trial's treatments could be effective for chronic cancer pain?

This trial will explore various strategies for managing chronic cancer pain. Studies have shown that a combination of different treatments, known as multimodal pain care, can effectively reduce pain and improve the quality of life for people with chronic pain. Research indicates that this approach can significantly lessen pain and decrease the need for pain-relieving medications. Participants in this trial may receive multimodal pain care for either 6 or 9 months.

Evidence suggests that non-opioid treatments can work as well as weaker opioids for managing cancer pain, with many patients experiencing good or excellent pain relief. Some participants will undergo medication optimization for either 6 or 9 months, with the possibility of transitioning to buprenorphine rotation or opioid tapering after 6 months.

Switching from other opioids to buprenorphine, a process called buprenorphine rotation, has reduced pain without causing withdrawal symptoms in many cases. This is one of the strategies being tested in this trial.

Gradually reducing opioid use, known as opioid tapering, has been linked to better function and quality of life for some patients. This trial will also evaluate the effects of opioid tapering following an initial period of medication optimization or multimodal pain care. Overall, these strategies offer promising alternatives to long-term opioid use for managing chronic cancer pain.12367

Who Is on the Research Team?

MJ

Maria J. Silveira, MD MA MPH

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

KF

Karleen F Giannitrapani, PhD MA MPH

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

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.
See 1 more

Exclusion Criteria

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 take less than 300mg of opioids daily.
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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Multimodal pain care 9 monthsExperimental Treatment1 Intervention
Group II: Multimodal pain care 6 months / Opioid tapering 3 monthsExperimental Treatment2 Interventions
Group III: Medication optimization 9 monthsExperimental Treatment1 Intervention
Group IV: Medication optimization 6 months/ Opioid tapering 3 monthsExperimental Treatment2 Interventions
Group V: Medication optimization 6 months/ Buprenorphine rotation 3 monthsExperimental Treatment2 Interventions
Group VI: Medication optimizationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

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.
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]

Citations

Evaluation of Buprenorphine Rotation in Patients ...This systematic review reports the potential for withdrawal, pain level, treatment success, adverse events, and other outcomes of ...
Evaluation of Buprenorphine Rotation in Patients ...Low-quality evidence suggested that buprenorphine rotation was associated with reduced pain without precipitating opioid withdrawal or other serious adverse ...
NCT06574009 | Better Options for Chronic Cancer PainAfter 6 months, non-respondents will be randomized to buprenorphine rotation or opioid tapering in Stage 2. The primary outcome is a composite variable ...
Should Buprenorphine Be Considered a First-Line Opioid ...Opioid conversion to buprenorphine reduced pain reported in 70% of the studies for which pain was a significant outcome (12/17 studies). The ...
(PDF) Evaluation of Buprenorphine Rotation in Patients ...Very low-quality evidence suggested that buprenorphine rotation was associated with maintained or improved analgesia, with a low risk of ...
Managing Cancer Related Pain and Opioid Dependence ...Buprenorphine is gaining increased popularity for its utility in the treatment of chronic pain, as its pharmacokinetic and safety advantages over full opioid ...
Use of Opioids for Adults With Pain From Cancer or Cancer ...A ≥ 20% reduction in pain intensity occurred in 88% of patients treated with low-dose morphine and 58% of patients treated with a weak opioid.
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