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Buprenorphine for Cancer Pain

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05910190
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
26
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Use of buprenorphine with FAO > 30 OME
  • Behavioral: CPM Rx application use
 Phase 4

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. There is a pay structure to compensate patients for CPM Rx use. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
prospective, single arm, open labelprospective, single arm, open label
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effective Use of Buprenorphine for Long-Acting Pain Relief in Combination With Short-Acting Full Agonist Opioids for Cancer Related Pain
Actual Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Oct 10, 2024
Anticipated Study Completion Date :
Oct 10, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Withdrawal while on Buprenorphine with Full Agonist Opioids [3 months]

    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.

  2. Maximum dose of FAO with Buprenorphine [3 months]

    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.

Secondary Outcome Measures

  1. Usage of CPM Rx [3 months]

    Usage of the app will be monitored and described at the end of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

Sponsors and Collaborators

  • Fox Chase Cancer Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marcin Chwistek, Director of Supportive Oncology and Palliative Care Program, Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT05910190
Other Study ID Numbers:
  • 21-1060
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Marcin Chwistek, Director of Supportive Oncology and Palliative Care Program, Fox Chase Cancer Center
Cancer Pain
buprenorphine
Additional relevant MeSH terms:
Cancer Pain
Buprenorphine

Study Results

No Results Posted as of Jun 18, 2023