Clinical trial · Interventional
Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer
NCT06935097CI-TRIAL-00112465enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean diet-based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention with Mediterranean Diet
- description
- Twenty-five (25) self-identified Black and/or Hispanic men with newly diagnosed (within 6 months) localized PCa or who have been managed on active surveillance for less than 5 years will be enrolled along with their spouses (if applicable).
- interventionNames
- Behavioral: Mediterranean diet-based Intervention
Primary outcomes (1)
- measure
- Safety and Adverse Events (AEs)
- timeFrame
- Through study completion; an average of 1 year
- description
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment. * Diagnosis within 12 months prior to enrollment OR * Currently managed on active surveillance, with initial biopsy being \<5 years from date of enrollment * Self-identified Hispanic and/or Black/African American * Patient at LBJ Hospital Exclusion Criteria: * Special dietary requirements such that patient is unwilling to attempt dietary change * Unwillingness to participate in study activities * Inability to keep appointments * Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy
References
Publications (0)
Data not yet available
No reference posted for this study.