Bone MetastasesEarly Phase 1NCT03661892
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
A Early Phase 1 study testing Syndros in people with Bone Metastases and Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bone Metastases, Breast Cancer, Pain
- What is being tested?
- Syndros
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2018to 26 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Metastases, Breast Cancer, Pain
- Being tested
- Syndros
- Keywords
- Breast Cancer, Bone Metastases, Pain, Opioid, Syndros, Bone pain
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyndrosDrug
Also called Dronabinol
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Syndros |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight weeks
Secondary outcomes (3)
Change in pain
To evaluate change in pain using the Brief Pain Inventory tool. Hypothesis: Addition of Syndros will decrease pain intensity on the rating tool.
Measured: Eight weeks
Change in quality of life
- 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.
Measured: Eight weeks
Change in bone modulation
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start19 Dec 2018
- Primary completion30 Oct 2020
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavani Chalasani, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661892
- Sponsor's protocol ID
- 1808852902
- Other IDs
- NCI-2018-01916
- Status last verified
- Apr 2021
- First submitted
- 5 Sep 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Segar J, Farr K, Junak M, Roe D, Ehsani S, Ibrahim M, Vanderah TW, Chalasani P. Evaluation of dronabinol to decrease opioid use for cancer-induced bone pain. Oncologist. 2026 Jul 8;31(8):oyag163. doi: 10.1093/oncolo/oyag163.
PubMed 42050177
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT03661892
- Acronym / sponsor ID
- 1808852902
- Conditions
- Bone Metastases, Breast Cancer, Pain
- Keywords
- Breast Cancer, Bone Metastases, Pain, Opioid, Syndros, Bone pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment (Syndros) | Experimental | Drug: SyndrosAll 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyndrosAlso: DronabinolAs 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 | Drug | Treatment (Syndros) |
Primary outcome
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.
3 secondary outcomes
Change in pain
Time frame: Eight weeks
Change in quality of life
Time frame: Eight weeks
Change in bone modulation
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 42050177Segar J, Farr K, Junak M, Roe D, Ehsani S, Ibrahim M, Vanderah TW, Chalasani P. Evaluation of dronabinol to decrease opioid use for cancer-induced bone pain. Oncologist. 2026 Jul 8;31(8):oyag163. doi: 10.1093/oncolo/oyag163.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavani Chalasani, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Syndros in people with Bone Metastases and Breast Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for opiate pain medication (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.