Trial Outcomes & Findings for Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients (NCT NCT03847311)

Last Updated: 2025-01-09

Results Overview

Brief Pain Inventory (BPI) pain severity score. Scale range: 0 (no pain) to 10 (worst pain imaginable) Higher values represent a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Twelve weeks

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebos Subjects will receive sugar pill. 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.	Sulfasalazine Subjects will receive the active 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.
Overall Study STARTED	3	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebos n=3 Participants Subjects will receive sugar pill. 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.	Sulfasalazine n=4 Participants Subjects will receive the active 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.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 8.0 • n=5 Participants	69.5 years STANDARD_DEVIATION 4.6 • n=7 Participants	65.1 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Twelve weeks

Population: All subjects who completed study.

Brief Pain Inventory (BPI) pain severity score. Scale range: 0 (no pain) to 10 (worst pain imaginable) Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	Placebos n=2 Participants Subjects will receive sugar pill. 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.	Sulfasalazine n=3 Participants Subjects will receive the active 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.
Overall Pain Relief.	1.9 score on a scale Standard Deviation 0.2	0.5 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Twelve weeks

Population: All subjects who completed the study.

Morphine Milligram Equivalents (MME) per day at 12 weeks.

Outcome measures

Outcome measures
Measure	Placebos n=2 Participants Subjects will receive sugar pill. 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.	Sulfasalazine n=4 Participants Subjects will receive the active 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.
Decrease Opiate Dose.	39.4 Morphine Milligram Equivalents per day Standard Deviation 14.3	33.2 Morphine Milligram Equivalents per day Standard Deviation 38.2

Adverse Events

Placebos

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sulfasalazine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Mohab Ibrahim

University of Arizona

Phone: (520) 626-7221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Placebos n=3 participants at risk Subjects will receive sugar pill. 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.	Sulfasalazine n=4 participants at risk Subjects will receive the active 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.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Blood and lymphatic system disorders	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Eye disorders Blurred Vision	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Abdominal Pain	33.3% 1/3 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Stomach Pain	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
General disorders Non-Cardiac Chest Pain	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
General disorders Pain	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Infections and infestations Urinary Tract Infection	33.3% 1/3 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Investigations Investigations - Other, specify	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Investigations Lymphocyte count decreased	33.3% 1/3 • Number of events 4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Investigations Platelet count decreased	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Investigations White blood cell decreased	66.7% 2/3 • Number of events 10 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Muscle cramp	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Ataxia	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Dizziness	66.7% 2/3 • Number of events 7 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Headache	100.0% 3/3 • Number of events 6 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Neuralgia	33.3% 1/3 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Paresthesia	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Psychiatric disorders Anxiety	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Renal and urinary disorders Proteinuria	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Reproductive system and breast disorders Vaginal discharge	33.3% 1/3 • Number of events 2 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	0.00% 0/4 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/3 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.	25.0% 1/4 • Number of events 1 • Through study completion, an average of 12 weeks The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.