Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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 may
also improve the side effects associated with opioid use. The purpose of this trial is to
co-administer sulfasalazine with opioids to cancer patients and characterize their pain and
the opioid use. Our hypothesis is that adding sulfasalazine to the pain medication, will
lower the amount of opioids used and lower the side effects. This may improve the quality of
life for patients and decrease the risks of using high amount of opioids for the patients,
their families, and society in general.