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

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ClinicalTrials.gov Identifier: NCT03661892
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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

Condition or disease Intervention/treatment Phase
Bone Metastases Breast Cancer Pain Drug: Syndros Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

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 Name: Dronabinol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661892


Contacts
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Contact: Pavani Chalasani, MD (520) 694-2873 pchalasani@uacc.arizona.edu
Contact: Amy Selegue, BA, BSN, RN (520) 626-0301 aselegue@email.arizona.edu

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85742
Contact: Dana Lewallen    520-626-2175      
Principal Investigator: Pavani Chalasani         
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Pavani Chalasani, MD University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03661892     History of Changes
Other Study ID Numbers: 1808852902
NCI-2018-01916 ( Registry Identifier: NCI Trial Identifier )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by University of Arizona:
Breast Cancer
Bone Metastases
Pain
Opioid
Syndros
Bone pain
Additional relevant MeSH terms:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Breast Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Analgesics, Opioid
Dronabinol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists