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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00988 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.
PRIMARY OBJECTIVES:
I. To assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (RPN) for a suspected renal malignancy.
SECONDARY OBJECTIVES:
I. To evaluate individual alterations in glomerular filtration rate (GFR) at 24 hours, 48 hours and one month following RPN and compare these to the placebo group.
II. To evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following RPN and compare these to the placebo group.
III. To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN.
IV. To describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit.
V. To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure.
VI. To compare overall complication rates (within 90 days postoperatively) between groups.
VII. To obtain a preliminary effect size of sildenafil on change in GFR at three months following RPN.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sildenafil citrate orally (PO) before the initiation of standard robotic partial nephrectomy.
ARM II: Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.
After completion of study treatment, patients are followed up at 1 and 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (sildenafil citrate) | Experimental | Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO before the initiation of standard robotic partial nephrectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate | Drug | Given PO |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Accrual rate | Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study. | Up to 6 months |
| Retention rate | Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits. | Up to 3 months |
| Participation rate | Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GFR | Regression analysis will be used; the change will be modeled, with adjustment for baseline GFR, to assess difference in the two study groups. | Baseline to up to 1 month |
| Change in proteinuria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Hemal | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| placebo | Other | Given PO |
|
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| therapeutic conventional surgery | Procedure | Undergo standard robotic partial nephrectomy |
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Compared between the two study groups.
| Baseline to up to 3 months |
| Estimated blood loss | Compared between the two study groups. | At 24 hours after RPN |
| Hemoglobin concentration | Compared between the two study groups. | At 24 hours after RPN |
| Changes in blood pressure measurements | Compared between the two study groups. | Baseline to up to 2 days after RPN |
| Vasopressor support requirements during the operative procedure | Compared between the two study groups. | During RPN |
| Intravenous fluid requirements during the operative procedure | Compared between the two study groups. | During RPN |
| Overall complication rates | Compared between the two study groups. | Up to 90 days after RPN |
| Preliminary effect size of sildenafil citrate on change in GFR | At 3 months |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |