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NCT03847311 · ClinicalTrials.gov registry record · Phase 2
Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients
A Phase 2 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03847311: Completed Phase 2 study, sponsored by University of Arizona.
NCT03847311 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847311, a Phase 2 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study 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 breast cancer, the number of patients with breast cancer are now living longer. This great achievement created an unexpected problem. For some breast cancer patients, with bone metastases, the pain is worse than the cancer. The golden standard to manage pain is opioids. Patients with cancer-induced bone pain are now taking increasing doses of opioids to control their pain. Sadly, opioids come with significant side effects that limit the amount of opioids that can be safely given. Many attempts have been tried to create better regiments for pain control to lower the need for opioids. There has not been significant success in that area. A better approach would be to add a non-opioid agent that has dual mechanisms of action. This may create synergism to better control pain while lowering the doses of opioids needed and lowering side effects. Sulfasalazine poses such quality it is a safe anti-inflammatory drug with established safety profile. It has been in use for over 50 years for the treatment of inflammatory conditions such as arthritis. In addition to its anti-inflammatory characteristics, sulfasalazine has the capacity to decrease the survival of cancer cells, also to lower the number of inflammatory mediators released by cancer cells. In short, sulfasalazine inhibit the influx of cysteine into cancer cells and the efflux of glutamate. Cysteine is needed for cell survival against oxidative stress, while glutamate activate pain receptors. Therefore, sulfasalazine will act as anti-inflammatory, an agent to accelerate cancer cells death and decreasing the released glutamate which activate pain receptors. This one agent with 3 mechanisms of actions may lower the amount of opioid needed for these patients while maintaining or improving their pain. Lowering of opioid dosing ma
Primary Outcome
Brief Pain Inventory (BPI) pain severity score. Scale range: 0 (no pain) to 10 (worst pain imaginable) Higher values represent a worse outcome.
Interventions
- DRUG Placebos
- DRUG Sulfasalazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 2 |
What the finished NCT03847311 record still lists
NCT03847311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03847311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03847311 about?
NCT03847311 is a clinical study titled "Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients". 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 breast cancer, the number of patients with breast cancer are now living longer. This great achievement ...
What is the current status of trial NCT03847311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-05-03. Estimated completion is 2023-10-09.
What interventions are being tested in trial NCT03847311?
The interventions under investigation include: Placebos (DRUG), Sulfasalazine (DRUG).
Who is sponsoring clinical trial NCT03847311?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03847311's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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