Buprenorphine for Cancer Pain

Trial Title: Buprenorphine for Cancer Pain

NCT ID: NCT05910190

Condition: Cancer-Related Pain

Conditions: Official terms:
Cancer Pain
Buprenorphine

Conditions: Keywords:
Cancer Pain
buprenorphine

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: prospective, single arm, open label

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Use of buprenorphine with FAO > 30 OME
Description: Patients will receive buprenorphine with concurrent FAO >30 OME and be assessed for withdrawal, pain, and other symptoms.
Arm group label: Intervention

Intervention type: Behavioral
Intervention name: CPM Rx application use
Description: 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.
Arm group label: Intervention

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fox Chase Cancer Center

Address:
City: Philadelphia
Zip: 19111
Country: United States

Status: Recruiting

Contact:
Last name: Marcin Chwistek, MD

Phone: 215-728-8080
Email: Marcin.Chwistek@fccc.edu

Start date: August 10, 2022

Completion date: October 10, 2024

Lead sponsor:
Agency: Fox Chase Cancer Center
Agency class: Other

Source: Fox Chase Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05910190