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Prostate CancerPhase 1NCT00006078

Lycopene In Preventing of Prostate Cancer

A Phase 1 study testing lycopene in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer. PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer. Read more about this study

Who is it for?
Ages 18 to 45 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
lycopene
How many people
Not given
Where
1 siteUnited States
Study dates
Jun 2000to Jan 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions
  • Baseline serum lycopene less than 600 nM

PATIENT CHARACTERISTICS:

Age:

  • 18 to 45

Performance status:

  • Karnofsky 100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Hematologic function normal

Hepatic:

  • Liver function normal
  • No hepatic disease

Renal:

  • Kidney function normal
  • No renal disease

Cardiovascular:

  • No hypertension requiring medication
  • No cardiovascular disease
  • Normal EKG

Other:

  • No evidence of a psychiatric disorder
  • Must be within 15% of ideal body weight based on standard weight tables
  • No history of smoking within the past 3 months
  • At least 72 hours since prior alcohol consumption and no history of alcohol abuse
  • No history of gastrointestinal malabsorption or any other condition that could affect drug absorption
  • No allergy to tomato based products
  • No active malignancy at any site
  • No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 14 days since prior prescription drugs
  • No concurrent regular prescription medications
  • At least 30 days since other prior experimental drugs
  • No concurrent participation in any other experimental trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Single Dose Pharmacokinetic Study of Lycopene Delivered in a Well Defined Food-Based Lycopene Delivery System (Tomato Paste-oil Mixture) in Healthy Male Volunteers Between 18 and 45 Years of Age

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.

Read the detailed description

OBJECTIVES:

  • Determine any dose limiting toxicities and the maximum tolerated dose of lycopene administered orally as a food based delivery system in healthy male subjects 18-45 years of age for the chemoprevention of prostate cancer.
  • Determine the pharmacokinetics of this regimen in this population.
  • Determine the dose range of this regimen to be used in the 3 month multiple dose study, based on the toxicity, pharmacokinetics and feasibility resulting from the present study in this population.

OUTLINE: This is a dose-escalation study.

Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains negligible carotinoid for 28 days.

Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicities.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
lycopene
Keywords
prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lycopeneDietary supplement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2000
  3. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006078
Sponsor's protocol ID
UIC-H-99-058
Other IDs
CDR0000067915, UIC-N01-CN-85081, NCI-P00-0143
Status last verified
Dec 2004
First submitted
3 Aug 2000
Last updated
26 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lycopene in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.

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