Can a traditional chinese granule ease a common cancer treatment side effect?
NCT ID NCT07355361
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding Huaier Granule to standard care can reduce proteinuria (excess protein in urine) in breast cancer patients who developed it as a side effect of immunotherapy or anti-angiogenic therapy. About 120 women will be randomly assigned to receive either standard care alone or standard care plus Huaier Granule for up to 24 weeks. The main goal is to see if the combination improves proteinuria treatment response after 8 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Huaier Granule
- What this could lead to
- If it works, this could offer a new way to manage proteinuria as a side effect of cancer treatment, potentially improving quality of life for breast cancer patients.
- What could go wrong
- This is a small Phase 2 trial, so results are preliminary. The granule may not reduce proteinuria better than standard care, and its long-term safety is not yet established.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
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 to 75 years
- Sex
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Female participants only
- 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: * \*\*Inclusion Criteria\*\* 1. Female patients aged 18-75 years. 2. Histopathologically confirmed diagnosis of breast cancer. 3. Currently receiving or having a prior history of immunotherapy and/or anti-angiogenic therapy. 4. First-time detection of proteinuria on urinalysis, graded as +, ++, or +++. 5. 24-hour urinary protein quantification between 0.15g and 3.5g (exclusive). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Karnofsky Performance Status (KPS) score ≥70. 8. No prior treatment with Huaier Granule within one month before enrollment. 9. Life expectancy of at least 6 months. 10. Willingness to voluntarily participate in the study and provision of signed informed consent. Exclusion Criteria: * \*\*Exclusion Criteria\*\* 1. Known history of chronic kidney disease (eGFR \<60 ml/min/1.73m²) or diabetic nephropathy. 2. Proteinuria attributed to other diseases, including but not limited to primary renal disease, hypertension, urinary tract infection, systemic lupus erythematosus, or multiple myeloma. 3. Current use of ACEI/ARB medications (unless the dosage has been stable for ≥4 weeks prior to enrollment). 4. Known allergy, contraindication, or specific precaution to any component of Huaier Granule. 5. Women who are pregnant, breastfeeding, or planning to conceive. 6. Concurrent participation in any other clinical trial investigating medications for proteinuria. 7. Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.
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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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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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