Phase 1
N=49
Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship
Stage 0a Bladder Cancer AJCC v8 · Stage 0is Bladder Cancer AJCC v8 · Stage I Bladder Cancer AJCC v8
Bottom Line
View on ClinicalTrials.gov: NCT04548193 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Urinary Isothiocyanates Levels — 10.4; 4.3 mM — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Behavioral Dietary Intervention (Behavioral); Educational Intervention (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Isothiocyanates Levels |
10.4; 4.3 | 0.28 |
| PRIMARY Cruciferae Intake Change |
0.78; 0.058 | .0054 sig |
| SECONDARY Gene Expression |
— | — |
| SECONDARY Change in Cruciferous Vegetable Intake, Cups/Day |
1.01; 0.07 | .0098 sig |
Summary
This phase I trial investigates how well a healthy eating program works in improving outcomes in patients with bladder cancer. The behavioral dietary program consists of educational materials, live phone calls, and interactive voice response phone messages. Participating in the healthy eating program may improve eating habits and/or reduce the risk of bladder cancer from coming back.
Eligibility Criteria
Inclusion Criteria
- CANCER PATIENT: Age 18 years old or older (no upper limit)
- CANCER PATIENT: English speaking
- CANCER PATIENT: Diagnosed with stage Tis, Ta, or T1 bladder cancer
- CANCER PATIENT: Resides in the Western New York catchment area
- CANCER PATIENT: Did not receive a partial or radical cystectomy
- CANCER PATIENT: Does not have a prior cancer diagnosis within 12 months of their bladder cancer diagnosis
- CANCER PATIENT: Does not have a subsequent more advanced bladder cancer diagnosis
- CANCER PATIENT: For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-2018, 2019-current
- CANCER PATIENT: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- PHYSICIAN: English speaking
- PHYSICIAN: Physician in a clinic located in the catchment area
- PHYSICIAN: Currently treats bladder cancer patients
Exclusion Criteria
- CANCER PATIENT: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- CANCER PATIENT: Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- CANCER PATIENT: Adults unable to consent
- CANCER PATIENT: Adults unable to complete study measures in English
- CANCER PATIENT: Individuals who are not yet adults (infants, children, teenagers)
- CANCER PATIENT: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- CANCER PATIENT: Unwilling or unable to follow protocol requirements
- PHYSICIAN: Unable to complete the study measures in English
Data sourced from ClinicalTrials.gov (NCT04548193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.