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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00003623

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arms

Duration (Months)

1.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Dietary Supplement: multivitamin Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Mar 1, 2003

Actual Study Completion Date :

Mar 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: multivitamin
Placebo Comparator: 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.	Other: Placebo

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: multivitamin

Placebo Comparator: 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.

Other: Placebo

Outcome Measures

Primary Outcome Measures

Prevention of reoccurence of early stage bladder cancer [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed stage 0 and I (Ta, T1 or Tis) resected transitional cell carcinoma of the bladder No advanced disease or muscle invasion No history of transitional cell carcinoma of the prostate

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Greater than 3 years Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy except nonmetastatic squamous cell or basal cell carcinoma of the skin No history of drug interactions which could affect therapy No immunodeficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior intravesical BCG required (if T1 or Tis pathology and negative cytology PAB) Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: Not specified Other: Intravesical therapy within 30 days allowed At least 30 days since greater than 2 multivitamins daily

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
3	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
4	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
5	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
6	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
7	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
8	CCOP - Duluth	Duluth	Minnesota	United States	55805
9	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
10	CentraCare Clinic	Saint Cloud	Minnesota	United States	56303
11	Medcenter One Health System	Bismarck	North Dakota	United States	58501
12	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
13	Altru Health Systems	Grand Forks	North Dakota	United States	58201
14	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
15	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
16	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
17	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Michael L. Blute, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00003623

Other Study ID Numbers:

NCCTG-979252
CDR0000066702
NCI-P98-0138

First Posted:

Feb 20, 2004

Last Update Posted:

Jul 13, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology

recurrent bladder cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Jul 13, 2016