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

NCT03661892 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 1808852902NCI-2018-01916
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Metastases; Breast Cancer; Pain

Keywords

Breast Cancer; Bone Metastases; Pain; Opioid; Syndros; Bone pain

Outcome Measures

Primary Outcomes (1)

• Need for opiate pain medication

  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 Outcomes (3)

• Change in pain

  Eight weeks

• Change in quality of life

  Eight weeks

• Change in bone modulation

  Eight weeks

Study Arms (1)

Treatment (Syndros)

EXPERIMENTAL

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

Interventions

Syndros DRUG

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

Also known as: Dronabinol

Treatment (Syndros)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85742, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Pavani Chalasani, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This a prospective single arm study enrolling patients (n=20) with bone metastases form breast cancer who have been on opioid therapy for bone pain for at least 4 weeks.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: December 19, 2018
• Primary Completion: October 30, 2020
• Study Completion: April 26, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)