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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
Sponsor:
Information provided by (Responsible Party):
Mohab Ibrahim, PhD MD, University of Arizona

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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chronic Pain Due to Malignancy (Finding) Drug: Sulfasalazine Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: Placebos
Subjects will receive sugar pill.
Drug: Placebos
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.
Drug: Sulfasalazine
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




Primary Outcome Measures :
  1. Overall pain relief. [ Time Frame: Twelve weeks ]
    By adding Sulfasalazine we hope to decrease the amount of pain intensity.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 94 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mohab M Ibrahim, PhD., MD 5208747246 mibrahim@anesth.arizona.edu

Locations
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United States, Arizona
Banner University Medical Center South Recruiting
Tucson, Arizona, United States, 85713
Contact: Mohab Ibrahim, PhD., MD    520-871-7246    mibrahim@anesth.arizona.edu   
Banner University Medical Center North Campus Recruiting
Tucson, Arizona, United States, 85719
Contact: Mohab Ibrahim, MD., Ph.D    520-874-7246    mibrahim@anesth.arizona.edu   
Contact: Vangie Steinbrenner    5206263099    vsteinbrenner@anesth.arizona.edu   
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Mohab M Ibrahim, PhD., MD University of Arizona
Publications:
Lifetime Probability of Developing and Dying From Cancer for 23 sites, 2009-2011. 2014.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohab Ibrahim, PhD MD, Director, Comprehensive Pain Management Clinic Associate Professor, Anesthesiology, University of Arizona
ClinicalTrials.gov Identifier: NCT03847311    
Other Study ID Numbers: 1605576856
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Chronic Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Sulfasalazine
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents