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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Bladder Cancer

Treatments: Dietary Supplement: multivitamin; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003623

CDR0000066702 (Registry Identifier)

NCCTG-979252

NCI-P98-0138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Multivitamin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: multivitamin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo