Clinical trial · Interventional
Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery
A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study
NCT02144649CI-TRIAL-00040357completedN/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 randomized pilot clinical trial compares tangerine and red tomato juice in treating patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found in tomatoes, may help prevent normal cells from transforming into cancer cells in patients with prostate cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Correlative studies | Other | — | UNRESOLVED |
| dietary intervention (red tomato juice) | Dietary Supplement | — | UNRESOLVED |
| dietary intervention (tangerine tomato juice) | Dietary Supplement | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Group I (control, no juice)
- description
- Patients consume no tomato juice.
- type
- EXPERIMENTAL
- label
- Group II (tangerine tomato juice)
- description
- Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
- interventionNames
- Dietary Supplement: dietary intervention (tangerine tomato juice)
- Other: questionnaire administration
- Other: Correlative studies
- type
- EXPERIMENTAL
- label
- Group III (red tomato juice)
- description
- Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Have biopsy proven carcinoma of the prostate * Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options * Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Not currently be taking tomato carotenoid dietary supplements or "alternative" products (e.g., lycopene supplements, Lyc-O-Mato, saw palmetto); vitamin A and beta-carotene supplements are allowed * Not be allergic to tomatoes or tomato products * Have plasma total cholesterol \< 200 mg/dL * Plasma triglycerides \< 200 mg/dL * Have blood urea nitrogen and serum creatinine (BUN/Cr) without clinically significant abnormalities after review by the study physicians * Liver enzymes without clinically significant abnormalities after review by the study physicians * Complete blood count (CBC) without clinically significant abnormalities after review by the study physicians * Prothrombin time (PT) without clinically significant abnormalities after review by the study physicians * Partial thromboplastin time (PTT) without clinically significant abnormalities after review by the study physicians * International normalized ratio (INR) without clinically significant abnormalities after review by the study physicians * Voluntarily agree to participate and sign an informed consent document * Agree to have prostate biopsy blocks provided to the study for evaluation * Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study * Agree to follow a low lycopene and phytoene diet Exclusion Criteria: * Have an active malignancy other than prostate cancer that requires therapy * Have a prostate biopsy with less than 5% cancer involvement * Have a history of traumatic or surgical castration * Have plasma total cholesterol \> 200 mg/dL * Have plasma triglycerides \> 200 mg/dL * Have a history of uncontrolled pituitary hormone diseases that currently require varying doses of supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone \[ACTH\], growth hormone) or other endocrine disorders requiring varying doses of hormone administration with the exception of diabetes and osteoporosis * Are planning to start certain medications after the trial enrollment; no new finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing new prescription medications for urinary outlet obstructive symptoms will result in discontinuing participation in this study; the use of new non-prescription substances to improve urinary tract symptoms will also result in discontinuing participation (i.e. saw palmetto, other herbal, alternative products); men who are currently taking finasteride or medications (meds) for urinary outlet obstructive symptoms may enroll in the study as long as there is no plan to change the dose in the weeks prior to surgery * Have a known allergy to tomatoes or have never consumed tomatoes * Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome \[IBS\]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome * Have significant loss of gastrointestinal organs, except for appendix, due to surgery * Have altered immunity such as autoimmune disorders, clinically significant anemia, hemophilia, and blood dyscrasias
References
Publications (0)
Data not yet available
No reference posted for this study.