Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03847311|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : January 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Chronic Pain Due to Malignancy (Finding)||Drug: Sulfasalazine Drug: Placebos||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The research pharmacist will randomize and prepare the drugs so that the drugs look similar, the pharmacist will dispense the drugs into vials, and label the drug so is not identified.|
|Official Title:||Double Blind Trial Investigating the Role of Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients|
|Actual Study Start Date :||May 3, 2021|
|Estimated Primary Completion Date :||January 2, 2023|
|Estimated Study Completion Date :||May 1, 2023|
Placebo Comparator: Placebos
Subjects will receive sugar pill.
This group will receive supplies for 3 months of sugar pills three times a day for 3 months. Subjects will be asked to take their medications with every meal in addition to their regular pain medications.
Other Name: Non-active
Active Comparator: Sulfasalazine
Subjects will receive the active drug.
This group will receive supplies for 3 months of sulfasalazine at an initial dose of 0.5 gram three times a day for a week then at a dose of 1 gram three times a day for the remainder of the 3 months. Subjects will be asked to take their medications with every meal in addition to their regular pain medications.
Other Name: Active treatment
- Overall pain relief. [ Time Frame: Twelve weeks ]By adding Sulfasalazine we hope to decrease the amount of pain intensity.
- Decrease opiate dose. [ Time Frame: Twelve weeks ]By adding Sulfasalazine we hope to decrease the daily use of opioids, lowering side effect of opioids, and capacity to perform more daily activities
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): NCT03847311
|Contact: Mohab M Ibrahim, PhD., MDemail@example.com|
|United States, Arizona|
|Banner University Medical Center South||Recruiting|
|Tucson, Arizona, United States, 85713|
|Contact: Mohab Ibrahim, PhD., MD 520-871-7246 firstname.lastname@example.org|
|Banner University Medical Center North Campus||Recruiting|
|Tucson, Arizona, United States, 85719|
|Contact: Mohab Ibrahim, MD., Ph.D 520-874-7246 email@example.com|
|Contact: Vangie Steinbrenner 5206263099 firstname.lastname@example.org|
|Principal Investigator:||Mohab M Ibrahim, PhD., MD||University of Arizona|