Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether adding daily hydroxytyrosol, a compound found in olives, to standard 5-fluorouracil-based chemotherapy (FOLFIRI or FOLFOX with cetuximab or bevacizumab) is safe and shows signs of anti-tumour activity. Hydroxytyrosol is given for two weeks before chemotherapy and continues during treatment, so the trial also examines how the body handles the combination.
The idea is that hydroxytyrosol could add anti-tumour activity to treatment patients would otherwise receive, but this trial mainly measures safety, side effects and drug-processing rather than whether people live longer or go longer before their cancer grows.
Worth knowing: This is a small, non-randomised phase I trial with no comparison group, so it cannot establish that hydroxytyrosol improves treatment outcomes.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06833866 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 33 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | The Methodist Hospital Research Institute |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Hydroxytyrosol
What it is measuring
Safety, Toxicity, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of HT in Combination with FOLFIRI/FOLFOX + Biologics
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a phase I study investigating the safety and antitumor activity of 5FU-based therapy (FOLFIRI/FOLFOX + Biologics) in combination with Hydroxytyrosol (HT) as a treatment for patients with advanced or metastatic colorectal cancer.
Patients will receive: 1 capsule of HT 25 mg daily for 2 weeks before beginning 5FU-based therapy (FOLFIRI/FOLFOX + Biologics), 1 capsule of HT (25 mg) daily for 2 weeks while receiving the FOLFIRI/FOLFOX + Biologics, until sign of disease progression.
The prescribed FOLFIRI/FOLFOX administer as: Irinotecan 180 mg/m² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m² IV over 120 minutes, followed by Fluorouracil 400-500 mg/m² IV bolus then 2400-3000 mg/m² IV infusion over 4-6 hours with or without, the designated Biologics, a standard dose of Cetuximab or Bevacizumab will be administered in 2-week cycles until disease progression or un-tolerated toxicity
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
A subject will be eligible for inclusion in this study only if all the following criteria are met:
1. Male or female ≥18 years of age.
2. Histopathologically or cytologically confirmed advanced or metastatic CRC.
3. Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.
4. Measurable disease per the RECIST v1.1.
5. Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Life expectancy ≥6 months.
7. Females of childbearing potential must agree to use birth control during the study and for 30 days after your last dose of HT, at least 9 months after your last dose of oxaliplatin, at least 3 months after your last dose of 5-FU, and at least 6 months after your last dose of irinotecan.
8. Male who are sexually active and their partner can become pregnant, must agree to use birth control during the study and for 30 days after their last dose of HT, at least 6 months after their last dose of oxaliplatin, at least 3 months after his last dose of 5-FU, and at least 3 months after his last dose of irinotecan.
–
Exclusion Criteria
Subjects must meet all the inclusion criteria listed above in Section 10.1 and none of the following exclusion criteria:
1. Hematology laboratory values of:
1. WBC of <3000 and absolute neutrophil count ≤1500 cells/mm3 with the Fy null phenotype.
2.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT06833866, registered by The Methodist Hospital Research Institute on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.