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Could a vitamin e boost chemo for advanced colon cancer?

NCT ID NCT04245865

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests whether adding tocotrienol, a form of vitamin E, to standard chemotherapy and bevacizumab can improve treatment and reduce side effects in people with metastatic colorectal cancer. About 83 participants will be randomly assigned to receive either tocotrienol or a placebo alongside their regular therapy for up to six months. The main goal is to see how many patients remain free of cancer progression at six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tocotrienol (a form of vitamin E) taken as a dietary supplement
What this could lead to
If it works, this could point toward a way to make standard chemotherapy and bevacizumab more effective and less toxic for people with metastatic colorectal cancer.
What could go wrong
This is a small, early-phase trial with only 83 participants, so results may not apply widely. Tocotrienol is a supplement, not a proven cancer drug, and may not improve outcomes or reduce side effects as hoped.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

83 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histopathologically verified adenocarcinoma of the colon or rectum * Metastatic disease * Planned treatment with FOLFOX or capecitabine combined with bevacizumab * Evaluable disease according to RECIST 1.1 * Performance status 0-2 * Expected survival ≥ 3 months * Patient acceptance to collection of blood samples for translational research * Age ≥ 18 years * Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted. * Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): * WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l * Platelet count ≥ 100 x 10\^9/l * Hemoglobin ≥ 6.0 mmol/l * Serum bilirubin ≤ 2.0 x ULN * Serum transaminase ≤ 2.5 x ULN * Serum creatinine ≤ 1.5 ULN * Urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g. * Written and orally informed consent Exclusion Criteria: * Other active malignant disease within 5 years prior to inclusion in the study. * Other experimental therapy within 28 days prior to treatment initiation. * Underlying medical disease not adequately treated. * Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab. * Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment * Bleeding tumor * Pregnant or breastfeeding women * Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment. * Hypersensitivity to one or more active substances or auxiliary substances

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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.

Contacts and locations

Locations

  • Department of Oncology, Vejle Hospital

    Vejle, 7100, Denmark

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