Hydromorphone Infusion Rates for Cancer Pain

Overseen By Joseph A Arthur

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chronic opioids

Disqualifiers: Opioid allergy, Nonmedical opioid use, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different rates of hydromorphone IV (a strong painkiller) affect its potential for misuse among cancer patients. The researchers aim to determine the best method for administering this medication to manage pain effectively while minimizing the risk of nonmedical opioid use. Participants will receive either a fast or slow infusion of hydromorphone to assess which method is safer and more effective. Ideal participants are hospitalized cancer patients experiencing moderate to severe pain who are not currently on regular opioid therapy. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to enhance understanding of its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are not on scheduled chronic opioid therapy. If you are only taking opioids as needed, you may still be eligible.

What is the safety track record for hydromorphone?

Research has shown that hydromorphone is generally well-tolerated for managing cancer pain. It works as effectively as other common pain relievers like morphine and oxycodone. Most patients report low pain levels when using it. One study found that hydromorphone helped reduce pain in patients with different types of cancer.

Strong evidence also supports its safety. In various trials, patients experienced similar pain relief without major differences in side effects. This suggests that hydromorphone is a reliable option for managing pain in cancer patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores different infusion rates of hydromorphone, a powerful opioid, to manage cancer pain more effectively. Unlike standard treatments that often rely on longer infusion times, this trial compares rapid versus extended hydromorphone administration to potentially provide faster pain relief. By alternating the infusion durations, the study aims to optimize pain management while minimizing side effects, which could enhance patient comfort and quality of life.

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

Research has shown that hydromorphone effectively manages cancer pain, offering relief comparable to other strong painkillers like morphine and oxycodone. In this trial, participants will receive hydromorphone at different infusion rates to assess its effectiveness. Patients using hydromorphone often report only mild pain, indicating effective discomfort control. It has proven to lessen pain in individuals with moderate to severe cancer pain. Overall, hydromorphone serves as a dependable choice for easing cancer-related pain, making it a strong option for those undergoing such treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Joseph Arthur, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for hospitalized cancer patients with moderate to severe pain who haven't been using opioids regularly. They must be able to understand and speak English, give consent, and have normal cognitive function without confusion or memory issues. People can't join if they misuse opioids, have liver or kidney problems, allergies to opioids, unstable vital signs like high heart rate or low oxygen levels.

Inclusion Criteria

I am currently hospitalized and have been diagnosed with cancer.

You don't have any noticeable problems with memory, concentration, or confusion.

Written informed consent from patient

Exclusion Criteria

I cannot take opioids due to allergies or other reasons.

Your heart rate is more than 120 beats per minute when you are not doing any physical activity.

You have a history of using opioids for nonmedical reasons, such as for abusing or misusing them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Patients receive IV hydromorphone and placebo in a crossover design to assess abuse liability and analgesic efficacy

2 weeks

Multiple visits for drug administration and monitoring

Treatment Phase II

Patients are crossed over to receive the alternate IV hydromorphone and placebo infusion rates

2 weeks

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hydromorphone

Trial Overview The study tests how the speed of giving hydromorphone (an opioid) through an IV affects its potential for abuse in controlling cancer pain. It compares slow versus fast infusion rates of hydromorphone while also looking at pain relief effectiveness and side effects related to different genetic responses.

How Is the Trial Designed?

Group I: Group B (hydromorphone, placebo) Experimental Treatment 3 Interventions

TREATMENT PHASE I: Patients receive hydromorphone IV over 15 minutes and placebo IV over 2 minutes. TREATMENT PHASE II: Patients receive hydromorphone IV over 2 minutes and placebo IV over 15 minutes.

Group II: Group A (hydromorphone, placebo) Experimental Treatment 3 Interventions

TREATMENT PHASE I: Patients receive hydromorphone IV over 2 minutes and placebo IV over 15 minutes. TREATMENT PHASE II: Patients receive hydromorphone IV over 15 minutes and placebo IV over 2 minutes.

Hydromorphone is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Dilaudid for:

• Moderate to severe pain

Approved in Canada as Hydromorphone for:

• Moderate to severe pain

Approved in European Union as Hydromorphone for:

• Moderate to severe pain

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Hydromorphone is effective and tolerable for managing moderate to severe cancer pain, based on a systematic review of 13 studies involving 1208 patients, but it does not show clear superiority over morphine or oxycodone.

The studies indicated that while hydromorphone and morphine provide similar pain relief, side effects varied slightly but were not consistent, suggesting that hydromorphone can be a viable alternative to traditional opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hydromorphone in cancer pain treatment: a systematic review. Pigni, A., Brunelli, C., Caraceni, A.[2018]

In a study involving 202 participants with severe opioid use disorder, injectable hydromorphone was found to have a better safety profile than diacetylmorphine, with fewer adverse events (AEs) and serious adverse events (SAEs) reported.

Despite both medications being administered under supervision, the diacetylmorphine group experienced higher rates of opioid overdoses, particularly in the first month of treatment, highlighting the importance of careful monitoring in opioid addiction therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of injectable hydromorphone and diacetylmorphine for long-term severe opioid use disorder. Oviedo-Joekes, E., Brissette, S., MacDonald, S., et al.[2018]

A systematic review of 25 studies on opioid use for cancer-related pain revealed a wide range of adverse event (AE) rates, with nausea reported between 3% and 85% and constipation between 5% and 97%, highlighting significant variability in patient experiences.

The review emphasizes that due to the heterogeneity in how AEs are assessed and reported across studies, realistic incidence rates for opioid-related AEs remain unclear, indicating a need for standardized measures in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Prospective Studies Reporting Adverse Events of Commonly Used Opioids for Cancer-Related Pain: A Call for the Use of Standardized Outcome Measures. Oosten, AW., Oldenmenger, WH., Mathijssen, RH., et al.[2022]

Citations

1. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02638-y

Efficacy and safety of hydromorphone for cancer pain Hydromorphone demonstrated efficacy similar to that of morphine and oxycodone in reducing cancer pain intensity, decreasing additional analgesic consumption, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6457981/

Hydromorphone for cancer pain - PMC - PubMed Central - NIH Participants generally achieved no worse than mild pain after taking hydromorphone, which is comparable with the other drugs. It produced a consistent analgesic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590014007202

Safety and Efficacy of Once-Daily Hydromorphone ... Beneficial reduction in pain severity with hydromorphone ER has been noted in moderate to severe cancer pain patients with all types of cancers, for treatment ...

4. jpsmjournal.com jpsmjournal.com/article/S0885-3924(05)00033-3/fulltext

Hydromorphone There is good evidence to support the use of hydromorphone as a pure opioid agonist for chronic cancer pain. These studies suggest it is equivalent to morphine ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21823

Opioid analgesics for nociceptive cancer pain: A ... In general, there was no significant difference in pain relief between buprenorphine and morphine, tramadol, fentanyl, or hydromorphone ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8406835/

Hydromorphone for cancer pain - PMC - PubMed Central - NIH We found no differences in pain intensity scores between the different treatment groups and on average patients reported low levels of pain ...

7. dovepress.com dovepress.com/a-randomized-double-blind-study-of-hydromorphone-hydrochloride-extende-peer-reviewed-fulltext-article-JPR

A randomized, double-blind study of hydromorphone ... The aim of this study was to assess the efficacy and safety of hydromorphone (DS-7113b) extended-release tablets in opioid-naïve patients with cancer pain.