Status:
COMPLETED
Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Prostate Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Filtricine Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 sou...
Detailed Description
Primary Objective: Determine the appeal/tolerability/palatability of a diet consisting solely of TalityTM synthetic meal replacement in participants with prostate cancer Secondary Objective: Evaluate ...
Eligibility Criteria
Inclusion
- 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 function
- 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 activities.
Exclusion
- 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 the study.
- 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 excluded.
- Pregnant or nursing patients will not be enrolled since prostate cancer is limited to males.
- 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.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04389918
Start Date
October 26 2020
End Date
February 26 2024
Last Update
February 28 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304