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Could a simple cream shield cancer patients from radiation burns?

NCT ID NCT07545720

Prevention Sponsor: Fudan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a cream called Pinoxin to see if it can prevent skin injuries caused by radiation therapy in cancer patients. About 202 adults receiving high-dose radiation will be randomly assigned to use either Pinoxin or a placebo cream. The main goal is to see if Pinoxin lowers the rate of moderate to severe skin burns.

What this could mean

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

Active substance
Pinoxin (a hydrogen-donor modified SOD skin protective agent)
What this could lead to
If it works, this could provide a simple preventive cream to reduce painful skin burns for cancer patients undergoing radiation therapy.
What could go wrong
This is a Phase 2 trial with 202 participants, so it is still early. The placebo group may show similar results, and the cream may not reduce severe skin injury 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

About 202 people

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

Started

Sep 2024

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, regardless of gender. 2. Pathologically diagnosed with a malignant tumor. 3. Scheduled to receive long-course radiotherapy with a total dose of ≥50 Gy, in accordance with standard treatment guidelines. 4. No prior history of radiotherapy. 5. Has provided signed and dated informed consent, indicating that the patient has been informed of all relevant aspects of the study. 6. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of dermatologic conditions (e.g., vitiligo, psoriasis, etc.) or collagen vascular diseases. 2. Planned hypofractionated radiotherapy regimen. 3. Recent use (e.g., within 3 months) of similar topical protective agents. 4. Known hypersensitivity to any related components or materials. 5. Immunodeficiency disorders. 6. Women who are pregnant or lactating. 7. Any other condition that, in the investigator's judgment, may compromise patient safety or protocol compliance. This includes severe concomitant illnesses (including psychiatric disorders) requiring active treatment, significant laboratory abnormalities, or significant social/familial factors.

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Conditions

The condition(s) this trial relates to.

cancer radiodermatitis prevention target

As listed by the trial registrant

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

Cancer patients undergoning radiotherapy

How to take part

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

  1. The places running it

    2 sites. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

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