Buprenorphine for Cancer Pain

Cancer-Related Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910190
• Other study ID #: 21-1060
• Status: Recruiting
• Phase: Phase 4
• Start date: August 10, 2022
• Est. completion date: October 10, 2024

Study information

• Verified date: July 2023
• Source: Fox Chase Cancer Center
• Contact: Marcin Chwistek, MD
• Phone: 215-728-8080
• Email: Marcin.Chwistek[@]fccc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 10, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Cancer-Related Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Usage of CPM Rx	Usage of the app will be monitored and described at the end of the study	3 months