A Phase 2 interventional study of Sulindac in Inflammation, Cancer and Pain, sponsored by Stony Brook University. Completed at 2 sites in United States. Open to female participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Stony Brook University · Phase 2, Interventional, and Treatment
This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.
To accomplish our study aims, we will conduct a phase II, single are trial of sulindac in postmenopausal women with early stage ER+ breast cancer who are receiving an aromatase inhibitor as adjuvant hormonal therapy. Approximately 75 breast cancer patients, stable on AI therapy (minimum of 3 months) for the treatment of their breast cancer will receive sulindac 150 mg bid for 12 months. Breast imaging will be conducted at baseline, 6 and 12 months.
The primary endpoint of the study will be change in the appearance of the contralateral, uninvolved breast as measured by quantitative Fat Water Ratio (FWR-MRI) mapping at 12 months in response to sulindac therapy. As changes in breast density in the contralateral, uninvolved breast will be the primary endpoint of the study, patients with bilateral breast cancer or those patients undergoing bilateral mastectomies or reconstruction surgery will be ineligible. Secondary endpoints of the trial include 12 month change in general pain and joint specific stiffness and pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A number of exploratory endpoints are planned and include comparison of MRI measures of the breast, tissue biomarkers, and pain at 6 months as early indicators of 12 month responses. For the tissue biomarkers, core needle biopsies will be obtained in a subset of women who consent to the procedure from the uninvolved contralateral breast at baseline and at 6 months. Tissue studies will include characterization of tissue histology (graded by cellularity and stromal elements) and molecular measures of proliferation and apoptosis.
3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.
This study's enrollment of 114 is above the median of 50 across 2,491 interventional studies indexed under Inflammation.
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Exclusion Criteria:
Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will receive 150 mg of sulindac twice daily for 12 months. They will receive up to 4 MRI within 12 months.
Drug: Sulindac
Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will continue their treatment will be monitored with MRI and standard of care tests every 6 months for up to 12 months.
Also known as: Clinoril
Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging
Adjusted estimates of relative change in percent breast density by magnetic resonance imaging
Time frame: Baseline and 12 months
Muscle and Joint Pain and Stiffness
The endpoint for arthralgia is change from baseline in Total Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index scores on a scale at 12 months. The Western Ontario and McMaster Universities Index is a self-administered questionnaire consisting of 24 items divided in 3 subscales: Pain, Stiffness, and Physical Function. Scores on the scale range from 0 to 96 for total WOMAC where 0 represents the best health status and 96 the worst possible status.
Time frame: Baseline and 12 months
Change in Mean Arterial Blood Pressure at 12 Months
Adjusted estimate of change in mean arterial blood pressure in each study arm at 12 months in each study arm.
Time frame: Change in blood pressure between Baseline and 12 months
All patients were enrolled at the University of Arizona Cancer Center and at the Stony Brook Cancer Center.
| Milestone | Sulindac (Clinoril) | Observational |
|---|---|---|
| Started | 58 | 56 |
| Completed | 43 | 40 |
| Not completed | 15 | 16 |
| Withdrew: Adverse event | 7 | 0 |
| Withdrew: Withdrawal by subject | 6 | 4 |
| Withdrew: Stopped taking ai aromatase inhibitor | 1 | 5 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Mri intolerant | 1 | 6 |
Adjusted estimates of relative change in percent breast density by magnetic resonance imaging
| percent change in breast density | Sulindac (Clinoril) | Observational |
|---|---|---|
| Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging | -9.8 (-14.6 to -4.7) | -3.6 (-8.9 to 2.0) |
The endpoint for arthralgia is change from baseline in Total Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index scores on a scale at 12 months. The Western Ontario and McMaster Universities Index is a self-administered questionnaire consisting of 24 items divided in 3 subscales: Pain, Stiffness, and Physical Function. Scores on the scale range from 0 to 96 for total WOMAC where 0 represents the best health status and 96 the worst possible status.
| score on a scale | Sulindac (Clinoril) | Observational |
|---|---|---|
| Muscle and Joint Pain and Stiffness | -5.85 (-9.73 to -1.96) | -0.25 (-3.25 to 2.69) |
Adjusted estimate of change in mean arterial blood pressure in each study arm at 12 months in each study arm.
| mm Hg | Sulindac | Observational |
|---|---|---|
| Change in Mean Arterial Blood Pressure at 12 Months | 0.77 (-1.82 to 3) | 1.52 (-1.17 to 4) |
Collected over Adverse event data were collected over 13 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sulindac (Clinoril) | 0/50 (0%) | 3/50 (6%) | 25/50 (50%) |
| Observational | 1/50 (2%) | 1/50 (2%) | — |
| Event | Sulindac (Clinoril) | Observational |
|---|---|---|
| Intraparenchymal Hemorrhage associated with cerebral amyloid angiopathyNervous system disorders | 1/50 | 0/50 |
| Transient Pancreatitis of Unclear EtiologyGastrointestinal disorders | 1/50 | 0/50 |
| B cell LymphomaBlood and lymphatic system disorders | 1/50 | 0/50 |
| Antral GastritisGastrointestinal disorders | 1/50 | 0/50 |
| deathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/50 | 1/50 |
| Event | Sulindac (Clinoril) | Observational |
|---|---|---|
| hypertensionVascular disorders | 7/50 | — |
| upset stomach or painGastrointestinal disorders | 6/50 | — |
| rashSkin and subcutaneous tissue disorders | 3/50 | — |
| headacheNervous system disorders | 3/50 | — |
| hyperglycemiaMetabolism and nutrition disorders | 3/50 | — |
| insomniaPsychiatric disorders | 3/50 | — |
For baseline analyses for the sulindac arm, we included only those participants who remained in the study after the NSAID washout and who started the intervention with sulindac (n=50). For the baseline analyses for the observation arm, we included those participants who either completed their baseline MRI and/or questionnaires for the secondary arthralgia endpoints (n=50).
| Age, Continuous(years) | Sulindac (Clinoril) | Observational | Total |
|---|---|---|---|
| Mean | 62.6 ± 5.5 | 64.2 ± 6.6 | 63.4 ± 6.1 |
| Sex: Female, Male(Participants) | Sulindac (Clinoril) | Observational | Total |
|---|---|---|---|
| Female | 50 | 50 | 100 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Sulindac (Clinoril) | Observational | Total |
|---|---|---|---|
| White, Non-Hispanic | 44 | 46 | 90 |
| Black, Non-Hispanic | 1 | 0 | 1 |
| Hispanic | 3 | 3 | 6 |
| Asian, Non-Hispanic | 2 | 1 | 3 |
| Region of Enrollment(Participants) | Sulindac (Clinoril) | Observational | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
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Studies of the drug tested here: Sulindac