Breast CancerNCT06881550
Real-world Study on Shenbailing Granules for Improving Qi and Blood Deficiency in Patients After Breast Cancer Surgery
A study testing Shenbailing in people with Breast Cancer, run by Caigang Liu at 1 site in China.
Trial summary
This study aims to explore the clinical efficacy of Shenbailing granules in improving quality of life and reducing cancer-related fatigue in a real-world setting, with the goal of providing clinical evidence for the use of Shenbailing granules in alleviating cancer-related fatigue among post-breast cancer surgery… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Shenbailing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following enrollment criteria to be enrolled in this trial:
- be 18-75 years of age (both 18 and 75);
- female;
- all patients have histologically confirmed breast cancer;
- expected to receive surgical treatment;
- expected survival of ≥ 1 year;
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- the level of function of vital organs must meet the following requirements:
- Bone marrow function Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 90 g/L;
- Liver and kidney function Albumin level ≥ 3.0 g/dL; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea nitrogen and serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula);
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Echocardiogram (ECHO) showing cardiac left ventricular ejection fraction (LVEF) ≥ 50%;
- 8. voluntarily accept the treatment and sign the informed consent form, have understood the purpose of this study and the experimental steps, good compliance, and comply with the relevant requirements of this trial protocol.
Who cannot join
- intolerance to or poor compliance with herbal medicines;
- inability to swallow, chronic diarrhea and intestinal obstruction, and the presence of multiple factors affecting the administration and absorption of medications;
- severe cardiac, hepatic, renal and other vital organ insufficiency;
- combination of serious complications, active infection, persistent fever, serious bleeding tendency, hematopoietic function abnormality;
- a known history of allergy to the drug components of this regimen;
- have a history of immunodeficiency, including testing positive for HIV, HCV, active viral hepatitis B, or suffering from other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation
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- a history of any cardiac disease, including (1) arrhythmia requiring medication or of clinical significance, (2) myocardial infarction, (3) heart failure, (4) any other cardiac disease judged by the investigator to be inappropriate for participation in the study, etc;
- pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial period;
- in the judgment of the investigator, have a serious concomitant medical condition that jeopardizes the patient's safety, or interferes with the patient's ability to complete the study (including, but not limited to, severe hypertension that cannot be controlled by medication, severe diabetes mellitus, active infection, etc.)
- is unconscious, non-verbal or non-reading, unable to communicate normally, and unable to cooperate in completing the questionnaire assessment;
- a previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia
- suspected or confirmed history of alcohol or drug abuse;
- any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Chian/Liaoning, 110022
About this study
Official title: A Single-center, Real-world Study of Shenbailing Granules in Patients After Breast Cancer Surgery
This study aims to explore the clinical efficacy of Shenbailing granules in improving quality of life and reducing cancer-related fatigue in a real-world setting, with the goal of providing clinical evidence for the use of Shenbailing granules in alleviating cancer-related fatigue among post-breast cancer surgery patients.
Read the detailed description
This study plans to enroll patients who have undergone breast cancer surgery. The experimental group will receive Shenbailing granule therapy, with the primary objective of exploring the improvement of postoperative cancer-related fatigue and quality of life in breast cancer patients treated with Shenbailing granules. Patients will enter the real-world study phase immediately after surgery.
Experimental group: Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery; Control group: Normal postoperative recovery without medication.
After confirming the surgery date, patients' quality of life, cancer-related fatigue, and breast cancer patient-reported outcome scales will be collected preoperatively, 1 day, 7 days, 14 days, and 28 days postoperatively to evaluate their quality of life and cancer-related fatigue. If patients are not tolerant to the medication, they will stop taking it.
- Conditions
- Breast Cancer
- Being tested
- Shenbailing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShenbailingDrug
Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal postoperative recovery without Shenbailing granules |
| TCM | Experimental | Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery Receives: Drug: Shenbailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Piper Fatigue Assessment score
The degree of cancer fatigue was assessed by piper Fatigue Assessment Scale
Measured: 1 day, 7 days, 14 days, and 28 days postoperatively
Secondary outcomes (2)
EORTC QLQ-C30 score
Measure the quality of life of cancer patients in different physical and psychological aspects
Measured: 1 day, 7 days, 14 days, and 28 days postoperatively
EORTC QLQ-BR23 score
Evaluate systemic treatment side effects, arm symptoms, breast symptoms, body image, and sexual function
Measured: 1 day, 7 days, 14 days, and 28 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start30 Dec 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caigang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caigang Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881550
- Sponsor's protocol ID
- SBL-RWS
- Status last verified
- Dec 2024
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Real-world Study of Shenbailing Granules in Patients After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06881550
- Acronym / sponsor ID
- SBL-RWS
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Caigang LiuUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the clinical efficacy of Shenbailing granules in improving quality of life and reducing cancer-related fatigue in a real-world setting, with the goal of providing clinical evidence for the use of Shenbailing granules in alleviating cancer-related fatigue among post-breast cancer surgery patients.
Detailed description
This study plans to enroll patients who have undergone breast cancer surgery. The experimental group will receive Shenbailing granule therapy, with the primary objective of exploring the improvement of postoperative cancer-related fatigue and quality of life in breast cancer patients treated with Shenbailing granules. Patients will enter the real-world study phase immediately after surgery.
Experimental group: Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery; Control group: Normal postoperative recovery without medication.
After confirming the surgery date, patients' quality of life, cancer-related fatigue, and breast cancer patient-reported outcome scales will be collected preoperatively, 1 day, 7 days, 14 days, and 28 days postoperatively to evaluate their quality of life and cancer-related fatigue. If patients are not tolerant to the medication, they will stop taking it.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal postoperative recovery without Shenbailing granules |
| TCM | Experimental | Drug: ShenbailingAdjuvant therapy with Shenbailing granules, starting from 1 day after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- be 18-75 years of age (both 18 and 75);
- female;
- all patients have histologically confirmed breast cancer;
- expected to receive surgical treatment;
- expected survival of ≥ 1 year;
Key exclusion criteria (13 listed)
- intolerance to or poor compliance with herbal medicines;
- inability to swallow, chronic diarrhea and intestinal obstruction, and the presence of multiple factors affecting the administration and absorption of medications;
- severe cardiac, hepatic, renal and other vital organ insufficiency;
- combination of serious complications, active infection, persistent fever, serious bleeding tendency, hematopoietic function abnormality;
- a known history of allergy to the drug components of this regimen;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShenbailingAdjuvant therapy with Shenbailing granules, starting from 1 day after surgery. | Drug | TCM |
Primary outcome
Piper Fatigue Assessment score
Time frame: 1 day, 7 days, 14 days, and 28 days postoperatively
The degree of cancer fatigue was assessed by piper Fatigue Assessment Scale
2 secondary outcomes
EORTC QLQ-C30 score
Time frame: 1 day, 7 days, 14 days, and 28 days postoperatively
EORTC QLQ-BR23 score
Time frame: 1 day, 7 days, 14 days, and 28 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shenbailing in people with Breast Cancer, run by Caigang Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Piper Fatigue Assessment score (time frame: 1 day, 7 days, 14 days, and 28 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.