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Could a common antioxidant shield cancer patients from painful mouth sores?

NCT ID NCT07736495

Symptom relief Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether alpha-lipoic acid, a powerful antioxidant, can prevent oral mucositis—painful mouth sores—caused by the chemotherapy drug 5-fluorouracil in colorectal cancer patients. Half of the 50 participants will take alpha-lipoic acid twice daily for six months, while the other half receive a placebo. The study measures oxidative stress levels and tracks how many patients develop mouth sores, aiming to see if this simple supplement can ease a common and distressing side effect.

What this could mean

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

Active substance
alpha-lipoic acid 600 mg twice daily
What this could lead to
If it works, this could offer a simple, low-cost way to prevent a painful side effect of chemotherapy, improving quality of life and treatment adherence.
What could go wrong
This is a small, early-phase trial. The antioxidant effect may not translate into fewer mouth sores, and alpha-lipoic acid could interact with chemotherapy.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

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: 1. Age \>18 years. 2. Newly diagnosed chemotherapy naive CRC patients 3. Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy. 4. Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upper normal limits). 5. Adequate kidney function (estimated glomerular filtration rate \>60 ml/min). 6. Adequate bone marrow function (WBCs count \> 3000 cells/mm3, ANC count \>1500 cells/mm3 and platelets count \> 100,000 cells/mm3). Exclusion Criteria: 1. Presence of other primary cancers. 2. Treatment with ALA for any other indication. 3. Allergy to ALA. 4. Pregnant or lactating women. 5. Patients with previous mucositis for any reason. 6. Patients who cannot tolerate oral intake. 7. Patients receiving other dietary antioxidant supplements.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Inflammation stomatitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nasser Institute for Research and Treatment.

    RECRUITING

    Cairo, Egypt

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