A Phase II Study Examining the Role of Fermented Soy Beverage for Improving Cancer-Associated Anorexia and Cachexia
Individuals who have cancer-related malnutrition have also been found to have a higher risk
of complications and are less able to tolerate the side effects of conventional therapies
such as chemotherapy, radiation, and surgery.
Haelan is a soy-based liquid (beverage). It contains large amount of isoflavones.
Isoflavones inhibit "nuclear factor-kappa B," which may lead to prevention of weight loss.
If you are eligible to take part in this study, you will then be given 2 fluid ounces of
Haelan, as a taste test. If you are not able to tolerate the taste of Haelan, you will not
be eligible for this study.
If you are able to pass the taste test and you are a woman who is able to have children, you
will be asked to have a pregnancy test 24 hours prior to registration to Part B. Then only
if you test negative for the pregnancy test will you be considered eligible for this study.
If you are a female patient and refuse to practice accepted methods of contraceptives during
the study, you will not be eligible for this study.
If you are still eligible for this study, you will have about 6 teaspoons of blood drawn,
for baseline routine tests. Your height and weight will be measured. You will be instructed
by a research nurse to recall your one day food intake before starting treatment. You will
be asked about any medications you are taking (especially any appetite stimulants, such as
megestrol, corticosteroid, and marinol), including the dose and when you take them. If you
are able to tolerate the taste of Haelan, you will be instructed to drink 4 ounces of Haelan
soy beverage 2 times a day, on an empty stomach, for 8 weeks. You may add water, stevia,
honey or artificial sweeteners into Haelan prior to drinking it to improve the tolerance of
Haelan. If you are unable to tolerate 4 ounces of Haelan twice a day after 2 attempts, the
dose will be reduced to 2 ounces twice a day. If you are still not able to tolerate it
after 2 attempts, the dose will be reduced again to 1 ounce twice a day. If you still
cannot tolerate drinking this Haelan dose after 2 more attempts, the dose will be reduced
again to 1 ounce daily. If you cannot tolerate at least 1 ounce a day for 5 consecutive
days, you will be taken off this study. If you vomit within half hour of taking the Haelan,
you should try at least 2 more times to drink at least 1 ounce of Haelan on the same day. If
unsuccessful, please record that you were not able to take the Haelan on that day. If you
cannot tolerate at least 1 ounce of Haelan a day for 5 days in a row, you will be taken off
If you are able to pass the taste test and if you are a female with child-bearing potential
you will be asked to have a pregnancy test 24 hours prior to registration to Part B .
You will be asked to write down how many ounces of Haelan you are able to drink at each dose
and each day, in a study-drug diary. You will be asked to write down the side effect of
You will be asked to write down the side effect of Haelan daily. You will have about 6
teaspoons of blood drawn for routine clinical tests, for protein level and kidney function
at Week 4 +/- 5 days. You will also be asked to complete 3 questionnaires that have
questions about any appetite, nausea, and fatigue you experience and your overall sense of
well being. These questionnaires will take about 15 minutes to complete. You will be given
several tests to measure your weight, skin-fold thickness and body composition. You will be
given 2 functional tests, which involves timing how long it takes for you to get up from a
chair to walk and timing how long it takes for you to walk 50 feet at your fastest speed.
These tests will take about 30 minutes to complete. The questionnaires, measurement of
your weight, skin-fold thickness and body composition, and functional tests will be done
before treatment starts and on a visit day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5
You will also be instructed by a research nurse to record your food intake, for one day in
day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days.
During this study, you will have several tests performed to check for safety and
effectiveness. Every 2 weeks, you will be asked if you are experiencing any side effects,
either related or not related to the treatment. You will be asked about any medications you
are taking, including the dose levels and when you take them.
You will be asked to bring the Haelan intake diary back to clinic on the study visits
between day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days, so the study staff can
record how many ounces of Haelan you have taken every day.
At the end of Haelan soy beverage treatment (week 8 +/- 5 days), you will be asked to return
to the clinic for a end-of-treatment visit. You will have blood drawn (about 6 teaspoons)
for routine clinic tests to detect for protein level and kidney function. Your study-drug
diary will be checked, and you will again be given the questionnaires. Measurement of your
weight, skin-fold thickness and body composition, and functional tests will be given. You
will be asked about any medications you are taking, including the dose levels and when you
take them. You will also be asked to provide the research nurse with the record of one day
food intake at 8 weeks +/- 5 days. The one day food intake record should be finished before
coming in for your clinic visit, as long as it is the recording of the 8th week food intake.
However, if the 8th-week clinic visit is on the first day of the 8th week, you can continue
to record your food intake after the visit, and then return it to the research nurse at a
later time. For this record, you need to write down what type of food you eat, and the
estimated portion (for example: rice, 2 ounces; slice of apple pie, 1/8 of a pie).
If you are currently taking megestrol, any corticosteroid, mirtazapine, metoclopramide, or
dronabinol and you change your dose while on study, you will be taken off study. Also, if
you were not on them before but you start taking any of the above listed drugs while on this
study, you will be taken off study.
This is an investigational study. About 32 people will take part in this study. All will
be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Decreases in Severity of Poor Appetite
Determination of treatment with Haelan (fermented soy product) ability to decrease severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
Ying Guo, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|