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Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Prostate Cancer
Trial ID: NCT04389918
This study will find out if a meal replacement of this type is satisfying and tolerable for men with prostate cancer. Participants will receive meal replacements of TalityTM as their expected sole source of nutrition for 4 weeks. The purpose of the study is to test whether TalityTM Synthetic Meal Replacements are suitable to be used in larger studies of patients with prostate or other types of cancer.
A Phase I Study of the Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Patients With Prostate Cancer
- Biopsy-proven prostate cancer with stable or rising PSA levels, defined as three
consecutive PSA levels, each value greater than 1 week apart, with fluctuation between
the three values no more than 10% downward. The third PSA needs to be within 30 days
prior to enrollment and >= 0.1.
- Patients may previously have been on any regimen of chemotherapy completed at least
one month prior. Patients may be on any stable form of anti-androgen therapy.
- Males >= age 18.
- All patients must have a life expectancy of > 6 months.
- Patients must have an ECOG Performance Status of <= 1
- Patients must have no clinically significant abnormalities of organ or bone marrow
- Patients must have the ability to understand and the willingness to sign a written
informed consent document, and the willingness/ability to comply with the protocol
- Chemotherapy within one month prior to enrollment or plans to receive chemotherapy
within one month after enrollment. Patients who are expected to require new or
modified anti-androgen therapy during the course of the study are also excluded.
- Patients may not be receiving any other Investigational Agents during the course of
- Patients who experience frequent symptoms of a gastrointestinal nature (e.g.,
diarrhea, abdominal bloating, constipation or pain) are excluded.
- Known CNS metastases.
- Patients who, in the opinion of the Principal Investigator, have a clinically
significant co-morbid disease that is likely to affect the ability of the patient to
complete the trial, interfere with their ability with measurement of self-reported
outcomes or result in adverse events unrelated to TalityTM are excluded.
- Patients with a history of food allergy are excluded.
- Concomitant medications necessary to treat baseline disorders are allowed (e.g.,
hypertension, diabetes, and hyperlipidemia).
- Patients requiring concomitant medications that, in the opinion of the Principal
Investigator, have an unacceptable risk of adverse effects due to their nature (e.g.,
anti-coagulant therapy, immuno-modulatory agents for autoimmune disease) must be
- Pregnant or nursing patients will not be enrolled since prostate cancer is limited to
- HIV-positive patients with active infections, HIV related cancer or poorly controlled
viral loads must be excluded. HIV-positive patients who are stable on anti-viral
therapy may be enrolled.
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