Buprenorphine for Cancer Pain

Effective Use of Buprenorphine for Long-Acting Pain Relief in Combination With Short-Acting Full Agonist Opioids for Cancer Related Pain

This study will evaluate patients on both buprenorphine and full agonist opioids (FAO) to assess for withdrawal symptoms. Patients will be evaluated by clinicians and using validated tools to assess for pain and withdrawal. At the same time, patients will use a CPM Rx application on their phone to track medication use.

Study Overview

• Status: Recruiting
• Conditions: Cancer-Related Pain
• Intervention / Treatment: Drug: Use of buprenorphine with FAO > 30 OME; Behavioral: CPM Rx application use

Detailed Description

This prospective study will recruit patients with pain related to cancer or its treatment who are on buprenorphine in combination with a full agonist opioid where dose of the full agonist opioids (FAO) is > 30 mg OME per day. They will be provided a mobile application (CPM Rx) for reporting of pain level daily and at each as needed dose. Withdrawal will be assessed using a modified Clinical Opioid Withdrawal Scale (COWS) score and patients will be instructed to be aware of changes in these symptoms. They will also be followed in person at the initial visit, and at days 14, 28, 56 , and 84 with Brief Pain Inventory (BPI) and COWS scale to assess for pain or withdrawal and other reported side effects. Pill counts will be done on days 28, 56, and 84 to further assess medication usage. Nurses will check-in to complete BPI and ask about withdrawal symptoms at days 42 and 70. The study seeks to assess if patients on buprenorphine and FAO have withdrawal symptoms, what are the highest doses of buprenorphine and FAO tolerated, and assess usage of the CPM Rx app. Each patient will be followed on the study for 3 months, unless the choose or it is deemed appropriate to end sooner.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Marcin Chwistek, MD; Phone Number: 215-728-8080; Email: Marcin.Chwistek@fccc.edu
• Study Contact Backup: Name: Dylan Sherry, MD; Phone Number: 215-728-8080; Email: Dylan.Sherry@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: Marcin Chwistek, MD; Phone Number: 215-728-8080; Email: Marcin.Chwistek@fccc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Age greater than or equal to 18 years
2. English speaking and able to understand and sign informed consent and HIPAA consent document.
3. The patient will have pain from any cause with a pain level greater than or equal to 4 on a visual analog scale.
4. The patient will be able to complete study assessments including use of the CPM app (requires Smart Phone)
5. Patients who may become pregnant are using adequate contraceptives.
6. Patient is on the combination of buprenorphine and full agonist opioid > 30 mg oral morphine equivalent or being started on both buprenorphine and full agonist opioid >30 mg oral morphine equivalent at the time of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.

Drug: Use of buprenorphine with FAO > 30 OME; Patients will receive buprenorphine with concurrent FAO >30 OME and be assessed for withdrawal, pain, and other symptoms.; Behavioral: CPM Rx application use; The CPM Rx application is used on smart phones to allow patients to input time-stamped data about medication type, dosage, and pain score. This will allow analysis of trends in self-reported pain and optimal dosing patterns. Usage over three months will be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal while on Buprenorphine with Full Agonist Opioids	Patients will be assessed on days 0 (baseline), 14, 28, 42, 56, 70, and 84 to assess for withdrawal using the validated COWS tool in conjunction with clinical assessment.	3 months
Maximum dose of FAO with Buprenorphine	Doses of buprenorphine and FAO will be assessed on days 0 (baseline), 14, 28, 42, 56, 70, and 84 with maximum dose of FAO and associated does of buprenorphine and maximum dose of buprenorphine and associated dose of FAO determined at the end of the study.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage of CPM Rx	Usage of the app will be monitored and described at the end of the study	3 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center

Publications and helpful links

General Publications

• Schmidt-Hansen M, Taubert M, Bromham N, Hilgart JS, Arnold S. The effectiveness of buprenorphine for treating cancer pain: an abridged Cochrane review. BMJ Support Palliat Care. 2016 Sep;6(3):292-306. doi: 10.1136/bmjspcare-2015-000939. Epub 2015 Dec 15.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): October 10, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: buprenorphine; Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 21-1060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No