Prostate CancerNCT07462403
A Prolonged Nightly Fasting for Men on ADT for PCa
A study testing Prolonged Nightly Fasting (PNF+) and Healthy Diet Text Messaging in people with Prostate Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prolonged Nightly Fasting (PNF+) and Healthy Diet Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to tolerate a normal diet (may include an active malabsorption syndrome at time of consent (i.e. Crohn's disease, major bowel resection leading to permanent malabsorption)
- Patients on concurrent chemotherapy will be excluded.
- ECOG score > 2
- Medications such as finasteride/dutasteride/saw palmetto are not allowed.
- Insulin injection or glyburide medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled
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.
Read the detailed description
Background/Objectives: This study aimed to assess the feasibility and acceptability of a 3-month health coaching intervention to promote PNF and healthy diet for men on ADT for PCa.
Methods: The study was carried out via a two-armed randomized controlled trial including 40 patients with PCa at a medical center in Philadelphia. During the 3-month period, the intervention group (PNF+) received health coaching utilizing an interactive text message system, and the control group received healthy eating text messages for the same duration. The outcome variables were feasibility and acceptability.
- Conditions
- Prostate Cancer
- Being tested
- Prolonged Nightly Fasting (PNF+), Healthy Diet Text Messaging
- Keywords
- Androgen Deprivation Therapy, ADT, metabolic disturbances, mobile text messaging, PCa, Nightly Fasting, telehealth coaching
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Nightly Fasting (PNF+)Behavioural
Also called interactive TXT-integrated intervention, Time-Restricted feeding, PNF+
participants will be invited to participate in weekly counseling calls with a trained health coach and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleep pattern data. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting.
Healthy Diet Text MessagingBehavioural
Also called health eating attention control group
Healthy Diet Group will receive general messages about healthy diet derived from AICR.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Nightly Fasting (PNF+) | Experimental | Participants will be invited to participate in weekly calls with a trained health coach during the and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleeping behaviors. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. The health eating attention control group: participants will Receives: Behavioral: Prolonged Nightly Fasting (PNF+) |
| Healthy Diet Group | Active comparator | The health eating attention control group: participants will receive text messages twice a day to focus on information and tips on general healthy eating, based on AICR evidence-based materials. Receives: Behavioral: Healthy Diet Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Rate
Percentage of eligible participants who consent and enroll in the study.
Measured: 12 months
Attrition Rate
Percentage of enrolled participants completing post-intervention follow-up.
Measured: Approximately 3 months
Time-Restricted Eating Compliance
Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE
Measured: Approximately 3 months
Number of Adverse Events
Number of Adverse Events
Measured: Approximately 3 months
Patient Satisfaction
Patient satisfaction, as measured from Client Satisfaction Quesionnaire-8 item version (CSQ-8), a validated measure that elicits the client's perspective on the value of serves received37. Qualitatively, a structured interview guide will be developed to assess the behavioral determinants (barriers and facilitators to adoption of the 16:8 TRE, including the usefulness and practicality of the PNF+ intervention and any specific feedback for improvement. Sample questions include: asking participants to: 1) identify the greatest benefit from PNF+ program; 2) indicate the greatest challenge from be compliant with the PNF+ program; 3) describe the way in which their neurological function or memory had changed (improved or worsened); and 4) indicate the driving force that bring them to participate in the PNF+ program.
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start2 May 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized with an allocation ratio of 2:1 to either the PNF+ intervention group or Healthy Diet Group.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Yi Wen, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462403
- Sponsor's protocol ID
- 19S.725
- Other IDs
- JT 42246
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled
- ClinicalTrials.gov ID
- NCT07462403
- Acronym / sponsor ID
- 19S.725
- Conditions
- Prostate Cancer
- Keywords
- Androgen Deprivation Therapy, ADT, metabolic disturbances, mobile text messaging, PCa, Nightly Fasting, telehealth coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Objectives: This study aimed to assess the feasibility and acceptability of a 3-month health coaching intervention to promote PNF and healthy diet for men on ADT for PCa.
Methods: The study was carried out via a two-armed randomized controlled trial including 40 patients with PCa at a medical center in Philadelphia. During the 3-month period, the intervention group (PNF+) received health coaching utilizing an interactive text message system, and the control group received healthy eating text messages for the same duration. The outcome variables were feasibility and acceptability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized with an allocation ratio of 2:1 to either the PNF+ intervention group or Healthy Diet Group.
| Arm | Type | Receives |
|---|---|---|
| Prolonged Nightly Fasting (PNF+) | Experimental | Behavioral: Prolonged Nightly Fasting (PNF+)Participants will be invited to participate in weekly calls with a trained health coach during the and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleeping behaviors. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. The health eating attention control group: participants will |
| Healthy Diet Group | Active comparator | Behavioral: Healthy Diet Text MessagingThe health eating attention control group: participants will receive text messages twice a day to focus on information and tips on general healthy eating, based on AICR evidence-based materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Nightly Fasting (PNF+)Also: interactive TXT-integrated intervention, Time-Restricted feeding, PNF+participants will be invited to participate in weekly counseling calls with a trained health coach and will be encouraged to fast at least 12 hours nightly, gradually increasing to 16 hours. This will be complemented by an interactive TXT system. Participants will interact with the study platform, to report when they begin and end their overnight fasting as well as their sleep pattern data. The platform will provide positive reinforcement messages when their fasting goal is successfully met as well as guidance and tips for fasting. | Behavioural | Prolonged Nightly Fasting (PNF+) |
| Healthy Diet Text MessagingAlso: health eating attention control groupHealthy Diet Group will receive general messages about healthy diet derived from AICR. | Behavioural | Healthy Diet Group |
Primary outcome
Accrual Rate
Time frame: 12 months
Percentage of eligible participants who consent and enroll in the study.
Attrition Rate
Time frame: Approximately 3 months
Percentage of enrolled participants completing post-intervention follow-up.
Time-Restricted Eating Compliance
Time frame: Approximately 3 months
Percentage of participants compliant with 70% of the intervention days (70% of 90 days = 63 days) with suggested TRE
Number of Adverse Events
Time frame: Approximately 3 months
Number of Adverse Events
Patient Satisfaction
Time frame: Approximately 3 months
Patient satisfaction, as measured from Client Satisfaction Quesionnaire-8 item version (CSQ-8), a validated measure that elicits the client's perspective on the value of serves received37. Qualitatively, a structured interview guide will be developed to assess the behavioral determinants (barriers and facilitators to adoption of the 16:8 TRE, including the usefulness and practicality of the PNF+ intervention and any specific feedback for improvement. Sample questions include: asking participants to: 1) identify the greatest benefit from PNF+ program; 2) indicate the greatest challenge from be compliant with the PNF+ program; 3) describe the way in which their neurological function or memory had changed (improved or worsened); and 4) indicate the driving force that bring them to participate in the PNF+ program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuang-Yi Wen, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Nightly Fasting (PNF+) and Healthy Diet Text Messaging in people with Prostate Cancer, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual Rate (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.