Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Breast Neoplasms

Pain

Bone Neoplasms

Bone Marrow Diseases

Breast Diseases

Skin Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Psychotropic Drugs

Analgesics, Opioid

Dronabinol

Hallucinogens

Analgesics, Non-Narcotic

Neurotransmitter Agents

Hormones

Hormone Antagonists

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).

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

Syndros

Pavani Chalasani, MD

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

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.

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.

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

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

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.

To evaluate change in pain using the Brief Pain Inventory tool. Hypothesis: Addition of Syndros will decrease pain intensity on the rating tool.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets	NCT03661892	Bone Metastases Breast Cancer Pain	Syndros	21 Years -	University of Arizona
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets	NCT03661892	Bone Metastases Breast Cancer Pain	Syndros	21 Years -	University of Arizona

Spots Global Cancer Trial Database for syndros

Every month we try and update this database with for syndros cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for syndros

Every month we try and update this database with for syndros cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for syndros cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.