High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Other: Placebo; Dietary Supplement: multivitamin

• Registration Number: NCT00003623
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of high-dose multivitamins may be an effective way to prevent the recurrence of early stage bladder cancer. It is not yet known whether high-dose vitamins are more effective than no further therapy in decreasing the risk of early-stage bladder cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose multivitamins with a placebo in preventing the recurrence of cancer in patients with early stage bladder cancer.

Detailed Description

OBJECTIVE: I. Determine whether high dose multivitamins have chemopreventive efficacy beyond standard therapy in reducing the risk of recurrence in patients with resected stage 0 and I (Ta, T1, and Tis) transitional cell carcinoma of the bladder.

OUTLINE: This is a randomized, double blind study. Patients are randomized to receive multivitamins or placebo orally once daily for 3 years. Patients are followed every 3 months for 2 years, then every 6 months for 1 year, and then annually thereafter.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted QC: 2004-02-19
• Study First Posted: 2004-02-20
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients receive placebo orally once daily for 3 years. Patients are followed every 3 months for 2 years, then every 6 months for 1 year, and then annually thereafter.
Multivitamin	multivitamin	Patients receive multivitamins orally once daily for 3 years. Patients are followed every 3 months for 2 years, then every 6 months for 1 year, and then annually thereafter.

Primary Outcome Measures

Name	Time	Method
Prevention of reoccurence of early stage bladder cancer	Up to 5 years

Trial Locations

Locations (17)

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Toledo Community Hospital Oncology Program; 🇺🇸 Toledo, Ohio, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

Medcenter One Health System; 🇺🇸 Bismarck, North Dakota, United States

CCOP - Duluth; 🇺🇸 Duluth, Minnesota, United States

CentraCare Clinic; 🇺🇸 Saint Cloud, Minnesota, United States

Altru Health Systems; 🇺🇸 Grand Forks, North Dakota, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Ann Arbor Regional; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Merit Care Hospital; 🇺🇸 Fargo, North Dakota, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States

Allan Blair Cancer Centre; 🇨🇦 Regina, Saskatchewan, Canada