140 Participants Needed

Methadone vs Hydromorphone for Pain Relief in Gynecologic Cancer

CT
KI
Overseen ByKaren Ishitani, R.N.
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

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic pain medications or anticoagulation medications, you may need to discuss this with the trial team.

What data supports the effectiveness of the drug hydromorphone for pain relief in gynecologic cancer?

Research shows that hydromorphone is effective for managing moderate to severe cancer pain, similar to other opioids like morphine and oxycodone. It is well-tolerated and can help reduce the need for additional pain medication.12345

Is hydromorphone safe for cancer pain management?

Hydromorphone has been shown to be generally safe for managing cancer pain, with common side effects including nausea, vomiting, constipation, drowsiness, and dry mouth. No severe adverse effects were observed in studies, and it is considered a tolerable alternative to other opioids like morphine and oxycodone.25678

How does the drug Methadone differ from other drugs for gynecologic cancer pain relief?

Methadone and Hydromorphone are unique in their use for pain relief in gynecologic cancer because they are opioids, which work by changing how the brain and nervous system respond to pain. This is different from other treatments like chemotherapy, which target cancer cells directly.910111213

What is the purpose of this trial?

This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.

Research Team

SC

Sean C. Dowdy, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for patients with gynecologic cancer who are undergoing surgery and need postoperative pain relief. The specific eligibility criteria aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely receiving the interventions.

Inclusion Criteria

I will be admitted to the hospital for more than a day.
I am having surgery through an abdominal cut for a female reproductive cancer.

Exclusion Criteria

Intolerance to hydromorphone or methadone
I cannot take liposomal bupivacaine due to health reasons.
I have had surgeries after my first major cancer surgery.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either methadone intravenously or hydromorphone intrathecally during induction of general anesthesia for surgery

1 day
1 visit (in-person)

Postoperative Monitoring

Patients are monitored for pain relief and side effects such as itching and respiratory depression

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Hydromorphone
  • Methadone
Trial Overview The study compares two pain relief methods after surgery: methadone (a long-acting opioid) versus intrathecal hydromorphone (similar to an epidural). It aims to determine which drug provides better postoperative pain management for these patients.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm II (hydromorphone)Experimental Treatment2 Interventions
Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
Group II: Arm I (methadone)Experimental Treatment2 Interventions
Patients receive methadone IV during induction of general anesthesia for SOC surgery.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

In a multicenter study involving 114 patients with chronic cancer pain, switching to once-daily OROS® hydromorphone significantly reduced the frequency of breakthrough pain (BTP) medication from 2.93 to 2.00 by day 14, indicating its effectiveness in managing pain.
Despite common side effects like constipation and dizziness occurring in 91.2% of patients, a majority (61.2%) reported satisfaction with the treatment, suggesting that OROS® hydromorphone is a viable option for controlling cancer pain.
Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.Lee, KH., Kim, MK., Hyun, MS., et al.[2013]
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.
The role of hydromorphone in cancer pain treatment: a systematic review.Pigni, A., Brunelli, C., Caraceni, A.[2018]
A systematic review of 8 studies involving 1283 participants found that hydromorphone does not show clear evidence of being more effective than other opioids like oxycodone or morphine for relieving cancer pain, indicating uncertainty in its analgesic efficacy.
The review also highlighted that while hydromorphone was associated with some adverse events such as nausea and constipation, there was no significant difference in these side effects compared to other opioids, suggesting a need for further research to clarify its safety and effectiveness.
Hydromorphone for cancer pain.Li, Y., Ma, J., Lu, G., et al.[2023]

References

Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients. [2013]
The role of hydromorphone in cancer pain treatment: a systematic review. [2018]
Hydromorphone for cancer pain. [2023]
The role of OROS hydromorphone in the management of cancer pain. [2013]
[Hydromorphone in Cancer Patients-A Retrospective Study]. [2020]
Safety and Tolerability of Once-Daily OROS(®) hydromorphone extended-release in opioid-tolerant adults with moderate-to-severe chronic cancer and noncancer pain: pooled analysis of 11 clinical studies. [2012]
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. [2022]
Comparative clinical efficacy and safety of a novel controlled-release oxycodone formulation and controlled-release hydromorphone in the treatment of cancer pain. [2022]
Platinum compounds in cervical and endometrial cancers: focus on carboplatin. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Chemotherapy for advanced or recurrent gynecologic cancer. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Role of docetaxel in the treatment of newly diagnosed advanced ovarian cancer. [2018]
12.Korea (South)pubmed.ncbi.nlm.nih.gov
The influence of hormone therapy with drospirenone-estradiol on endometrioid type endometrial cancer patients. [2019]
[Effect of anticancer drugs on in vitro survival of cell lines derived from various gynecologic tumors (author's transl)]. [2006]
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