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Sulfasalazine for Pain Management in Breast Cancer

Phase 2
Recruiting
Led By Mohab M Ibrahim, PhD., MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pain duration of at least 6 weeks or more.
Diagnosis of cancer with moderate to severe pain on stable doses of opioids.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twelve weeks
Awards & highlights

Study Summary

This trial is testing whether adding sulfasalazine to pain medication will lower the amount of opioids used and the side effects experienced by cancer patients.

Who is the study for?
This trial is for adult breast cancer patients aged 18-94 with moderate to severe pain managed by stable opioid doses. They must have had pain for at least 6 weeks, a life expectancy over 6 months, and be able to take pills and rate their pain. Excluded are those with addiction issues, severe depression, language barriers, legal conflicts related to pain, certain medical conditions or medication interactions.Check my eligibility
What is being tested?
The study tests if Sulfasalazine can reduce the need for opioids in managing chronic cancer-related bone pain in breast cancer patients. It's compared against a placebo while both groups continue their regular opioid regimen. The drug has anti-inflammatory properties and may help kill cancer cells and decrease activation of pain receptors.See study design
What are the potential side effects?
Sulfasalazine might cause allergic reactions in some people or interact with other medications leading to unwanted effects. Common side effects include digestive issues like upset stomach or nausea; however it generally has a well-established safety profile from long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing pain for 6 weeks or more.
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I have cancer with moderate to severe pain and am on a stable opioid dose.
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I can take pills by mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twelve weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and twelve weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall pain relief.
Secondary outcome measures
Opiate Alkaloids

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SulfasalazineActive Control1 Intervention
Subjects will receive the active drug.
Group II: PlacebosPlacebo Group1 Intervention
Subjects will receive sugar pill.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,554 Total Patients Enrolled
22 Trials studying Breast Cancer
2,524 Patients Enrolled for Breast Cancer
Mohab M Ibrahim, PhD., MDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Sulfasalazine Clinical Trial Eligibility Overview. Trial Name: NCT03847311 — Phase 2
Breast Cancer Research Study Groups: Sulfasalazine, Placebos
Breast Cancer Clinical Trial 2023: Sulfasalazine Highlights & Side Effects. Trial Name: NCT03847311 — Phase 2
Sulfasalazine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03847311 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for participants in this research?

"Indeed. The information archived on clinicaltrials.gov attests that this medical trial, which was originally published on May 3rd 2021, is currently enrolling patients in a bid to acquire 40 volunteers across 2 research centres."

Answered by AI

Are there currently any opportunities to join this trial?

"Affirmative. According to the clinicaltrials.gov registry, this research initiative is actively recruiting participants and was initially published on May 3rd 2021. A total of 40 patients are needed from two distinct locations for the study's completion."

Answered by AI

What therapeutic benefits has Sulfasalazine been known to offer?

"Sulfasalazine is typically employed to alleviate the symptoms of polyarticular juvenile rheumatoid arthritis, chronic or unspecified. However, it may also offer relief from Crohn's disease, Ulcerative colitis, and Proctitis."

Answered by AI

Has Sulfasalazine been sanctioned by the Federal Drug Administration?

"Although there is evidence of Sulfasalazine's safety, it lacks clinical data to support its efficacy, so we have assigned a score of 2."

Answered by AI

Does this research encompass participants aged 85 and over?

"This study only permits patients between the ages of 18 and 94 to enroll. However, there are 108 trials that admit participants younger than 18 years old and 2862 studies that accept those older than 65."

Answered by AI

Who fulfills the qualifications to become an enrollee of this research?

"This experiment is recruiting 40 individuals between 18 and 94 years of age who have been diagnosed with breast cancer. The following criteria must be fulfilled for candidates to qualify: providing informed consent, understanding English, 3-day NPRS average pain rating of 5/10 or higher, being on stable doses of opioids at baseline evaluation, having had the condition for 6+ weeks, a prognosis greater than 6 months and ability to take oral medication."

Answered by AI
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~7 spots leftby Jan 2025