Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

April 27, 2021 updated by: University of Arizona

Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This a prospective single arm study enrolling patients with bone metastases from breast cancer who have been on opioid therapy for bone pain for at least 4 weeks. All patients start on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study period (total of 8wks). For patients who have side effects secondary to Sydnros, the dose will be decreased. Side effect assessment will be done by the research team 2 days after making the dose adjustment. If subject continues to have side effects, dose will be held until resolution of symptoms. If the study medicine is held for more than a week continuously, they will be taken off the study. In addition, they will have baseline blood and urine collected for biomarkers and also complete study related questionnaires (for secondary end points). They are also provided an opioid drug diary which they will take home during visit 1 to record their opioid pain medication use. Research staff will be calling patients on a weekly basis to reinforce opioid drug diary, assess for Syndros side effect, and adjust dose of Syndros. At the end of 8 weeks blood and urine is collected again and they will complete the study questionnaires.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85742
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
  2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines
  3. Have metastatic breast cancer with bone metastases
  4. Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
  5. Age ≥ 21 years
  6. Must be on opioid therapy for bone pain for at least 4 weeks

Exclusion Criteria:

  1. Have a known sensitivity to dronabinol or alcohol
  2. Have a history of hypersensitivity reaction to alcohol
  3. Using medical marijuana currently
  4. Using Syndros for nausea or appetite stimulant
  5. Receiving or have received disulfiram- or metronidazole- containing products within past 14 days
  6. Are currently pregnant or are of child-bearing age and refuse to use adequate contraception
  7. Have a history of psychiatric illness
  8. Have a history of seizure disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (Syndros)
All patients start on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study period (total of 8wks).
Drug: Syndros

As noted in arm description. For patients who have side effects secondary to Sydnros, the dose will be decreased as below:

Dose subject is taking Reduction recommendation 8.4mg BID Decreased to 8.4mg AM , 4.2mg PM (or it can be 4.2g in AM and 8.4mg in PM- depending on their side effect timing) 8.4mg AM, 4.2mg PM (or vice versa) 4.2mg BID 4.2mg BID 4.2mg once a day 4.2mg once a day Stop and take off study

Other Names:
  • Dronabinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for opiate pain medication
Time Frame: Eight weeks
To evaluate change in opiate pain medication use after addition of Syndros.Hypothesis: Syndros will decrease the opiate usage by at least 20% at the end of 8wks. We will evaluate opioid pain medication use by using a drug diary and assessing the percentage change in opiate pain medication requirement at end of 8wks.
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain
Time Frame: Eight weeks
To evaluate change in pain using the Brief Pain Inventory tool. Hypothesis: Addition of Syndros will decrease pain intensity on the rating tool.
Eight weeks
Change in quality of life
Time Frame: Eight weeks
2. To evaluate change in quality of life using the EORTC QLQ-C30 version 3.0 questionnaire. Hypothesis: Addition of Syndros will improve quality of life.
Eight weeks
Change in bone modulation
Time Frame: Eight weeks
To evaluate change in bone modulation by Syndros. Hypothesis: Syndros will decrease bone degradation there by decreasing serum and urine C-terminal telopeptide collagen cross-linker (CTX), N-terminal telopeptide (NTX) and increase osteocalcin.
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2018

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1808852902
  • NCI-2018-01916 (Registry Identifier: NCI Trial Identifier)

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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