Clinical trial · Interventional
Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence
Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma
NCT00609310CI-TRIAL-00006188suspendedPhase 2ClinicalTrials.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)
Prove the hypothesis that dietary supplementation with bioflavonoids will diminish the recurrence rate of colonic neoplasia, we will implement a clinical trial comparing bioflavonoids and placebo in a double blind randomized clinical trial. To use a standardised supplementation of bioflavonoids, a commercially available preparation (Flavo-Natin®) will be used.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flavonoids | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Flavonoid treatment
- interventionNames
- Dietary Supplement: Flavonoids
Primary outcomes (1)
- measure
- Recurrence rate of neoplasia
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Recurrence free survival, Overall survival, Serum-Flavonoid levels of patients
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who had a recent surgical resection of colorectal cancer with pathologically proven stage 2 or stage 3 (without adjuvant chemotherapy or after completion of adjuvant chemotherapy) according to UICC. The time interval for recruitment should be within 3-12 month after surgery. * Male or female * caucasian * 50 to 75 years old * Broca-index: between -20 and +25% * who are willing and capable to confirm written consent to enrolment after ample information has been provided * who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study Exclusion Criteria: * subjects with any major relevant clinical abnormality (as based on extensive medical history, physi-cal examination, vital signs) * subjects with active cancer * subjects with any major clinically relevant laboratory abnormality. * subjects who participated in another trial with any investigational substance within the last 4 weeks * subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol abuse during the active study phase * subjects who adhere to a extreme diet or lifestyle that might interfere with the investigation * subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy * subjects who are known or suspected not to be capable of understanding and evaluating the in-formation that is given to them as part of the formal information policy (informed consent), in par-ticular regarding the risks and discomfort to which they would agree to be exposed
References
Publications (0)
Data not yet available
No reference posted for this study.