Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04389918|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : February 28, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Tality||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I Study of the Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Patients With Prostate Cancer|
|Actual Study Start Date :||October 26, 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
Participants will receive TalityTM as their sole intake for nutritional purposes for a 4 week period.
Synthetic meal replacements, delivered in many varieties of 400 kCal packets, Manufacturer: Filtricine, Inc.
- Proportion of Completers [ Time Frame: 4 weeks ]The proportion of participants who complete the 4 week study using TalityTM as their sole source of nutrition at a high level of adherence (75% of days, 21+ days out of the 28 day study).
- Change in weight from baseline [ Time Frame: 4 weeks ]Change in weight will be measured from baseline.
- Change in amino acid levels [ Time Frame: 4 weeks ]Change in amino acid levels as compared to baseline will be measured. The following amino acids will be analyzed a-Aminoadipic Acid, a-Aminobutyric Acid, Alanine, Arginine, Asparagine, Aspartic Acid, b-Alanine, b-Aminoisobutyric Acid, Citrulline, Cystathionine, Cystine, Ethanolamine, Glutamic Acid, Glutamine, Glycine, Histidine, Homocystine, Hydroxyproline, Isoleucine, Leucine, Lysine, Methionine, Ornithine, Phenylalanine, Proline, Sarcosine, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valine. It will be measured in micro-moles per Liter.
- Change in Prostate Specific Antigen [ Time Frame: 4 weeks ]Change from baseline in the serum level of prostate specific antigen (PSA).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389918
|United States, California|
|Stanford, California, United States, 94304|
|Principal Investigator:||Randall S Stafford, MD, PhD||Stanford Universiy|
|Responsible Party:||Stanford University|
|Other Study ID Numbers:||
PROS0100 ( Other Identifier: OnCore )
IRB-55337 ( Other Identifier: Stanford IRB )
|First Posted:||May 15, 2020 Key Record Dates|
|Last Update Posted:||February 28, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases