Olive extract joins chemo in fight against advanced colon cancer
NCT ID NCT06833866
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests whether adding hydroxytyrosol, a natural compound found in olives, to standard chemotherapy can safely help people with advanced or metastatic colorectal cancer. About 33 adults who are eligible for first-line treatment will take a daily capsule of hydroxytyrosol for two weeks before and during their chemo cycles. The main goal is to check safety and how the body processes the combination, while also tracking tumor response and progression-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hydroxytyrosol (a natural compound from olives) combined with standard chemotherapy (FOLFIRI/FOLFOX) and biologics
- What this could lead to
- If it works, this could point toward a way to make standard chemotherapy more effective for advanced colorectal cancer.
- What could go wrong
- This is a very early Phase 1 trial with only 33 people, focused on safety. It may not show any benefit, and the combination could cause additional side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Platelets ≤100,000 cells/mm3 3. Hemoglobin ≤9 g/dL (Fe infusion is allowed to correct anemia in iron deficient anemia patients, per standard-of-care) 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase: 1. \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or 2. \>2.5 × ULN if no liver metastases are present. 3. Serum albumin \<2.8 g/dL. 4. Total bilirubin \>1.5 × ULN or \>1.5 mg/dL. 5. Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits. 6. Estimated glomerular filtration rate \<50 mL/min. 7. Positive pregnancy test, pregnant, or breastfeeding (female patients only). 8. Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study. 9. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to: 1. Arrhythmia 2. Bradycardia 3. Tachycardia 4. Symptomatic valvular disease 5. Symptomatic congestive heart failure classified by the New York Heart Association as Class III or IV 6. Unstable angina pectoris. 10. Myocardial infarction within the past 6 months. 11. Active bleeding diathesis (platelets less than 100,000 or active bleeding) 12. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months. 13. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agents 14. Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2. 15. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption. 16. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month. Note: Influenza vaccine will be allowed if administered \>21 days. 17. Receipt of any investigational agent or study treatment within the past 30 days. 18. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months. 19. Patients must be able to swallow oral capsules. 20. Participants with metastatic CRC and microsatellite instability-high or deficient mismatch repair tumors. 21. surgical Surgery, within 12-months or less. 22. For patients to be treated with bevacizumab: history of gastrointestinal fistula or perforation, major surgery within 28 days of study treatment initiation, recent hemorrhage, arterial thromboembolic events or deep venous thrombosis within 6 months, uncontrolled hypertension (i.e., BP \> 150/90 mm Hg), proteinuria, and hemoptysis. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist.
RECRUITINGHouston, Texas, 77030, United States