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CompletedNCT04389918Updated Feb 28, 2024

Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Prostate Cancer

An interventional study of Tality in Prostate Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study 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 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.

Read the 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 the effect of TalityTM on safety parameters including laboratory tests, nutritional status and adverse effects

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 16 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Tality

    Participants will receive TalityTM as their sole intake for nutritional purposes for a 4 week period.

    Other: Tality

Interventions

  • OtherTality

    Synthetic meal replacements, delivered in many varieties of 400 kCal packets, Manufacturer: Filtricine, Inc.

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What researchers measure

Primary outcomes

  1. Proportion of Completers

    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).

    Time frame: 4 weeks

Secondary outcomes

  1. Change in weight from baseline

    Change in weight will be measured from baseline.

    Time frame: 4 weeks

  2. Change in amino acid levels

    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.

    Time frame: 4 weeks

  3. Change in Prostate Specific Antigen

    Change from baseline in the serum level of prostate specific antigen (PSA).

    Time frame: 4 weeks

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Study locations

1 site
  • Stanford University
    Stanford, California 94304, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04389918
Lead sponsor
Stanford University
Collaborators
Filtricine Inc.
Responsible party
Sponsor
First posted
May 15, 2020
Start date
Oct 26, 2020
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024
Last update
Feb 28, 2024

Study contacts

Randall S Stafford, MD, PhD
principal investigator · Stanford Universiy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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