Healthy, no Evidence of DiseasePhase 1NCT00450957
Lycopene in Healthy Male Participants
A Phase 1 study testing lycopene and pharmacological study in people with Healthy, no Evidence of Disease and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease, Prostate Cancer
- What is being tested?
- lycopene and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2007
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers judged to be in good medical condition based on history and physical exam
- Karnofsky performance status 100%
- AST and ALT ≤ 75 IU/L
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Hemoglobin ≥ 13.0 g/dL
Show all 27Show fewer
- WBC ≥ 4,000/mm³
- Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
- Must be within height and weight standards identified by Metropolitan Life scales
- Nonsmoker (for ≥ 3 months)
- No history of alcohol abuse
- No history of gastrointestinal malabsorption or other condition that could affect drug absorption
- No history of a psychiatric condition
- No chronic medical condition
- No active history of any of the following:
- Cancer
- Liver disease
- Cardiovascular disease
- Renal disease
- Diabetes mellitus
- Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
- No allergy to tomato-based products
- No lycopene in the diet for ≥ 14 days
- At least 4 weeks since prior and no other concurrent experimental medications
- No concurrent participation in another experimental study
- No concurrent use of regular prescription medication or over-the-counter medications
- No concurrent vitamin, mineral, or herbal supplements
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age
This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.
Read the detailed description
OBJECTIVES:
- Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.
II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.
III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.
Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.
PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
- Conditions
- Healthy, no Evidence of Disease, Prostate Cancer
- Being tested
- lycopene, pharmacological study
- 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
Also called all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-Carotene
Given orally
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (high-dose lycopene) | Experimental | Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days. Receives: Dietary Supplement: lycopene; Other: pharmacological study |
| Arm II (low-dose lycopene) | Experimental | Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days Receives: Dietary Supplement: lycopene; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
Measured: 2 weeks
Safety according to NCI CTC version 3.0
Measured: 12 weeks
Pharmacokinetics
Measured: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Keith Rodvold, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450957
- Sponsor's protocol ID
- NCI-2012-02709
- Other IDs
- UIC-2006-0853, CDR0000536181, N01CN85081
- Status last verified
- Apr 2013
- First submitted
- 20 Mar 2007
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age
- ClinicalTrials.gov ID
- NCT00450957
- Acronym / sponsor ID
- NCI-2012-02709
- Conditions
- Healthy, no Evidence of Disease, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.
Detailed description
OBJECTIVES:
- Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.
II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.
III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.
Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.
Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.
PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (high-dose lycopene) | Experimental | Dietary Supplement: lycopene, Other: pharmacological studyParticipants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days. |
| Arm II (low-dose lycopene) | Experimental | Dietary Supplement: lycopene, Other: pharmacological studyParticipants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- Healthy volunteers judged to be in good medical condition based on history and physical exam
- Karnofsky performance status 100%
- AST and ALT ≤ 75 IU/L
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 1.5 mg/dL
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lycopeneAlso: all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-CaroteneGiven orally | Dietary supplement | Arm I (high-dose lycopene), Arm II (low-dose lycopene) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (high-dose lycopene), Arm II (low-dose lycopene) |
Primary outcome
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
Time frame: 2 weeks
Safety according to NCI CTC version 3.0
Time frame: 12 weeks
Pharmacokinetics
Time frame: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Rodvold principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lycopene and pharmacological study in people with Healthy, no Evidence of Disease and Prostate Cancer, run by National Cancer Institute (NCI) 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?
The sponsor lists 27 inclusion and 0 exclusion criteria. 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 15 Apr 2015. 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.
What does the primary outcome measure?
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0 (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2015.