A Prolonged Nightly Fasting for Men on ADT for PCa (NCT07462403) | Clinical Trial Compass
CompletedNot Applicable
A Prolonged Nightly Fasting for Men on ADT for PCa
United States40 participantsStarted 2024-05-02
Plain-language summary
This small study tested a 3-month text-based health coaching program for men with prostate cancer on hormone therapy. The program was feasible and well accepted, with participants showing good engagement and some improvements in weight and quality of life. However, differences between groups were not statistically significant, so larger studies are needed to confirm the benefits.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
* Must be 18 years of age or older
* Provide signed and dated informed consent form
* Had a histological diagnosis of PCa (Stage IIA-IVB)
* Are beginning or receiving ADT (including medical castration with LHRH-agonist-antagonist androgen receptor modulators) for PCa with an anticipated duration of ≥ 3 months. The ADT is defined as: (a) Gonadotropin Releasing Hormone (GNRH) agonist (including leuprolide \[Lupron/Eligard\], goserelin \[Zoladex\], triptorelin \[Trelstar\], histrelin \[Vantas\], and abiraterone \[Zytiga\]) alone; (b) GNRH agonist with oral androgen receptor blockade (including bicalutamide \[Casodex\], flutamide \[Eulexin\], and enzalutamide \[Xtandi\]), and (c) GNRH agonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors. Patients on androgen receptor modulators and second-generation androgen receptor antagonists will qualify.
* Intermittent ADT will be allowed as long as the overall duration is more than 3 months.
* BMI ≥25 kg/m2
* Radiation therapy will be allowed concurrently.
* Willing and able to comply with the protocol for the duration of the study
* Able to speak, read and write English
* Has a mobile phone with TXT capability.
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
* Inability to tolera…