Status:
COMPLETED
Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Chronic Pain Due to Malignancy (Finding)
Eligibility:
FEMALE
18-94 years
Phase:
PHASE2
Brief Summary
Cancer in general, and breast cancer in specific, is a significant health problem in the USA and the rest of the world. With the improvement of new surgical approaches and chemotherapies to manage bre...
Detailed Description
In the United States, approximately one in two men and one in three women will develop cancer. Today, more than 15 million people live with cancer in the United States alone. The direct annual medical...
Eligibility Criteria
Inclusion
- Adult patient age 18 - \<95 years old capable of understanding and providing consent in English and capable of complying with the outcome used.
- Diagnosis of cancer with pain moderate to severe pain on stable doses of opioids
- 3-day average numeric pain rating score (NPRS) for pain of at least 5/10 at baseline evaluation.
- Patient consents to double blind design of the experiment in a shared decision- making process with the treating physician.
- Pain duration of at least 6 weeks or more.
- Prognosis greater than 6 months.
- Able to take oral medication
Exclusion
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Subjects with intestinal or urinary obstruction or at risk of such disorders.
- Porphyria
- Blood dyscrasias, hepatic or renal disease.
- Taking medications that may interact with sulfasalazine.
- Taking Lapatinib or Digoxin.
- No sustained hypercalcemia.
- Hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates.
- The Subject is incarcerated.
- Those unable to read English and complete the assignment in English.
- Addictive behavior, severe clinical depression, or psychotic features.
- Possible pregnancy or lactation.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03847311
Start Date
May 3 2021
End Date
October 9 2023
Last Update
January 9 2025
Active Locations (2)
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1
Banner University Medical Center South
Tucson, Arizona, United States, 85713
2
Banner University Medical Center North Campus
Tucson, Arizona, United States, 85719