A Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Pomegranate Juice or Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer
Some studies suggest that diets with certain plant-based sources (plant chemicals) may help
to reduce the risk of diseases, such as cancer and heart disease.
Pomegranate liquid extract is identical to pomegranate juice, but has a higher concentration
of ingredients that are known to prevent damage to cells.
The placebo used in this study is a juice made by the study sponsor that looks and tastes
like pomegranate liquid extract, but it does not have active ingredients, such as plant
Before beginning screening for this study, you will be checked to make sure you do not have
any allergic reaction to pomegranate liquid extract. You will be asked to drink one 4-ounce
(1/2 cup) sample of pomegranate juice, mixed with pomegranate liquid extract, and placebo.
You will then be watched by the study staff for about 30 minutes. If any signs and symptoms
of allergic reactions are seen, appropriate medical attention will be provided, and you will
not be able to proceed to the screening for this study. If you do not experience any signs
of symptoms of allergic reactions, you will proceed to the screening for this study.
Before you can start on this study, you will have "screening tests." These tests will help
the doctor decide if you are eligible to take part in this study. You will have your
complete medical history recorded. You will have a physical exam, including measurement of
your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and
weight. You will have a digital (insertion by a finger) rectal exam. You will be asked to
complete a food-frequency questionnaire, which will ask about what types of fruits and
vegetables you eat and how often you eat them. It will take about 20 minutes to complete.
You will also have a quality-of-life (QOL) questionnaire that will ask about your health,
activities that might be affected by your health, and/or about pain that you have recently
had. It will take about 15 minutes to complete this questionnaire.
If you have diabetes and have not had your blood sugar levels tested in the past 3 months,
you will have blood drawn (about 1 tablespoon) to check your HbA1c (which will show your
blood sugar levels).
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to 1 of the 2 study groups (pomegranate liquid extract or
placebo). Participants in one group will receive pomegranate liquid extract. Participants in
the other group will receive placebo. There will be a 2 out of 3 chance that you will
receive pomegranate liquid extract.
You will be notified by telephone call about 7 days after your screening visit that you are
eligible to take part in the study. You will also be told the delivery date for your study
juice and a study-product diary.
This is a double-blinded study, which means that neither you nor your doctor or any medical
staff involved in your care, will know which product you receive until the study is
complete. However, the study doctor can find out which product you are receiving (if there
is an emergency or if it is necessary to know for your health).
The study drink will be shipped to M. D. Anderson and then shipped to you directly from M.
D. Anderson. It should be refrigerated immediately when you receive it. You will drink an
8-ounce (1 cup) pomegranate liquid extract or placebo each day (7 days a week) for 52 weeks
(about 1 year). All bottles of the study drink should be refrigerated until you are ready to
drink it. You will receive detailed instructions on how to drink the study drink when you
receive your first week's supply. You will continue to drink the study drink for 52 weeks
or until your PSA levels do not appear to be responding.
A telephone call will be made approximately 7 days after your screening visit. At this
time, you will be informed of your eligibility to participate in the study, and that you
have been randomized. You will be informed of the delivery date for your study drink and a
study-product consumption diary.
During this study, you will be asked to return to the clinic every 13 weeks (Weeks 13, 26,
39, and 52). You will see the research nurse at Weeks 13, 26, and 39, and you will see the
study doctor at Week 52. During these visits, you will have a physical exam, including
measurement of your vital signs and weight. You will be asked if you are taking any
medications. You will have blood drawn (about 3 to 4 teaspoons) and urine collected for
routine tests. You will be asked if you have been drinking the study drink each day. You
will be given a study-product consumption diary with instructions to record that you drank
the drink daily. It will be given to you at each 13-week follow-up visit. You will be asked
not to begin or to stop taking any new nutritional or dietary supplements while you are on
this study so that your supplements do not interfere with the effects of the study drink.
If the disease gets worse while you are on study, you and your study doctor will be able to
find out which study group you were in. If you were taking the placebo, you may be eligible
to enter into another study where you will receive the pomegranate extract for up to 12
During your last study visit (Week 52), you will have a physical exam, including measurement
of your vital signs and weight. You will have a digital rectal exam. You will be asked about
any medications you may be taking. You will have blood drawn (about 3 to 4 teaspoons) and
urine collected for routine tests. You will be asked if you have been drinking the study
drink each day for the last 13 weeks of the study (your consumption diary will be reviewed).
You will be given another food-frequency questionnaire and QOL questionnaire like the ones
that were given during screening.
This is an investigational study. Up to 200 participants will take part in this multicenter
study. Up to 40 will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Mean Serum PSA Doubling Time at End-of-treatment
Daily consumption of pomegranate liquid extract versus placebo on end-of-treatment (52 weeks) prostate-specific antigen (PSA) doubling time in male subjects who have rising serum PSA levels after primary therapy for localized prostate cancer.
Curtis A. Pettaway, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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