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Ancient herbal mix may soothe radiation burns in breast cancer patients

NCT ID NCT07380230

Symptom relief Sponsor: LI FENG Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a traditional Chinese herbal formula called Qibei Jiedu can prevent or ease the painful skin rash (radiation dermatitis) that often occurs during breast cancer radiotherapy. Sixty women with early-stage breast cancer will receive either the herbal drink or a placebo alongside standard care for three weeks. The goal is to see if the formula reduces severe skin reactions and improves quality of life, but this is a small, early trial meant to guide future research, not to prove effectiveness.

What this could mean

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

Active substance
Qibei Jiedu Formula (a traditional Chinese herbal decoction)
What this could lead to
If it works, this could offer a natural option to reduce painful skin reactions during breast cancer radiation therapy.
What could go wrong
This is a very small, early exploratory trial with only 60 participants, designed to gather hints, not proof. The herbal formula may not work better than placebo, and side effects are not yet well understood.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

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

Female participants only

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: * Patients with pathologically confirmed unilateral stage I-III non-inflammatory breast cancer, having undergone breast-conserving surgery or modified radical mastectomy, and having received or planned to receive standard adjuvant therapy according to current clinical guidelines. * Scheduled to receive postoperative adjuvant radiotherapy using a hypofractionated regimen (40-50 Gy/15 fractions) as recommended by the NCCN Breast Cancer Guidelines and the CSCO Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition). * Meeting the TCM diagnostic criteria for the syndrome of Qi-Yin Deficiency with Blood Stasis and Toxin Accumulation. * Karnofsky Performance Status (KPS) score ≥70. * Age ≥18 years, female. * Voluntarily participating in the study and providing written informed consent. Exclusion Criteria: * Presence of grade 4 radiation dermatitis requiring urgent intervention at enrollment or during the study. * Prior radiotherapy to the breast or chest within the past 3 months. * Any skin condition that may interfere with the assessment of radiation dermatitis, such as active infection, atopic dermatitis, psoriasis, vitiligo, active collagen vascular disease (e.g., scleroderma, lupus erythematosus), or other known autoimmune disorders significantly altering skin appearance or physiological response. * Pre-existing grade ≥2 hepatic/renal dysfunction or hematological toxicity (according to CTCAE v5.0 criteria) before treatment. * Concurrent participation in other clinical trials or concurrent use of other Chinese herbal preparations. * Unstable mental status or inability to cooperate with the study procedures. * Pregnant or lactating patients. * Known allergy to any component of the herbal formula used in this study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm radiodermatitis prevention target

As listed by the trial registrant

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

Acute radiation dermatitis Breast cancer Traditional chinese medicine (TCM)

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

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.