Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02355886
Other study ID # 9274
Secondary ID NCI-2015-0008392
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 22, 2015
Est. completion date February 28, 2019

Study information

Verified date May 2019
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II/III trial studies gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.


Description:

PRIMARY OBJECTIVES:

I. To assess if perioperative gabapentin will decrease post-operative analgesic requirements within the first 48 hours after radical cystectomy (RC) in patients undergoing RC as measured morphine equivalents.

SECONDARY OBJECTIVES:

I. To assess patient self-assessment of postoperative pain on Numeric Pain Scale (NPS) at 24 and 48 hours.

II. To assess time to return of bowel function (ROBF).

III. To assess length of stay (LOS) following RC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive gabapentin orally (PO) thrice daily (TID) for 48 hours after surgery.

ARM II: Patients receive placebo PO TID for 48 hours after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 28, 2019
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosis of bladder cancer

- Anticipated radical cystectomy with ileal conduit or orthotopic neobladder

Exclusion Criteria:

- Presence of spinal cord injury including any form of paraplegia or quadriplegia

- Allergy to gabapentin

- Active alcohol dependence, defined as 2 or more positive questions on the CAGE alcoholism questionnaire

- Illicit drug use (excluding recreational marijuana)

- Chronic kidney disease with glomerular filtration rate < 30 ml/min

- Pregnancy: All female patients < 55 years old (yo) will be administered a urine pregnancy test prior to enrollment

- Non-English speaking patients

- Chronic gabapentin, or the similar drug pregabalin, use

- Chronic narcotic use (daily or near daily use for > 90 days)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gabapentin
Given PO
Other:
Placebo
Given PO
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) Geometric Mean and Standard Deviation of patient total equivalent analgesic 48 hours post-radical cystectomy
Secondary Length of Stay Following Radical Cystectomy The two study groups will be compared by Length of stay following radical cystectomy duration of hospital stay. Days to weeks
Secondary Patient Self-assessed Pain on Numerical Pain Scale The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity. Up to 48 hours post-radical cystectomy
See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Active, not recruiting NCT05399004 - Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
Recruiting NCT03824691 - hARnessing CAbozantinib and Durvalumab Immuno-oncology Association: ARCADIA Study" Phase 2
Recruiting NCT04502095 - Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy Phase 4
Completed NCT03125226 - TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer N/A
Withdrawn NCT05564416 - Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial Phase 2
Terminated NCT02169284 - Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery Phase 2
Recruiting NCT05519878 - Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers N/A
Active, not recruiting NCT02439060 - PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit) N/A
Recruiting NCT04410302 - Patient-Derived Xenografts to Reduce Cancer Health Disparities
Withdrawn NCT04054752 - Vaccine Response With NT-I7 Phase 1
Terminated NCT03549650 - Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms Phase 2
Completed NCT00469066 - Cone Beam CT Scanning in Lung and Bladder Cancer. N/A
Active, not recruiting NCT03757949 - Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery Phase 3
Completed NCT03064308 - The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery N/A
Active, not recruiting NCT02432963 - Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy Phase 1
Active, not recruiting NCT02408406 - PatientCareAnywhere Internet-Based Software in Improving Communication and Education in Patients With Cancer and Their Healthcare Providers N/A
Recruiting NCT06109857 - Bladder Bank (a Prospective Banking Study)
Terminated NCT02145390 - Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy N/A
Terminated NCT01245660 - A Phase 0 of Neoadjuvant Lapatinib in Infiltrative Bladder Carcinoma Before Cystectomy Phase 0