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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Normal postoperative recovery without Shenbailing granules | |
| TCM | Experimental | Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenbailing | Drug | Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Piper Fatigue Assessment score | The degree of cancer fatigue was assessed by piper Fatigue Assessment Scale | 1 day, 7 days, 14 days, and 28 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-C30 score | Measure the quality of life of cancer patients in different physical and psychological aspects | 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 |
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Inclusion Criteria:
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;
the level of function of vital organs must meet the following requirements:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Shenyang | Chian/Liaoning | 110022 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 1 day, 7 days, 14 days, and 28 days postoperatively |
| D017437 |
| Skin and Connective Tissue Diseases |