Shenqi Shiyiwei Granule for breast cancer related fatigue-centered symptom cluster: protocol of a multicenter randomized double-blind placebo-controlled trial
4 affiliations
- 1Department of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
- 2Beijing University of Chinese Medicine
- 3Shandong Second Medical University
- 4Beijing Institute of Chinese Medicine
Abstract
Background: Breast cancer survivors frequently experience fatigue-centered symptom clusters—concurrent, interrelated symptoms including fatigue, pain, and dyspnea—that significantly impair quality of life and functional status. Despite the high prevalence of these symptoms, few interventional trials have targeted symptom clusters as a unified treatment endpoint. Current management relies predominantly on behavioral interventions with inconsistent efficacy, and no pharmacological agent has demonstrated high-quality evidence for cluster-level symptom control in this population.
Methods: This multicenter, randomized, double-blind, placebo-controlled trial will enroll 262 postoperative breast cancer survivors (stage I–IIIA) with moderate-to-severe fatigue-centered symptom clusters from 11 hospitals across China. Eligible participants must have completed adjuvant therapy, exhibit an ECOG performance status of 0–1, and present with a MDASI-C fatigue-dyspnea-pain subscale score ≥4. Participants will be randomized 1:1 to receive either Shenqi Shiyiwei Granule or matching placebo for 60 days, with standardized psycho-exercise-dietary guidance provided to all participants throughout a 120-day study period. The primary endpoint is the change from baseline in the fatigue-dyspnea-pain symptom cluster score at 2 months, assessed using the MD Anderson Symptom Inventory-Chinese version (MDASI-C). Secondary endpoints include quality-of-life measures (MFSI-SF, FACT-B, TCM Spleen Qi Deficiency Scale) and cardiopulmonary functional capacity. Exploratory biomarker analyses will evaluate hypothalamic-pituitary-adrenal axis hormones, cytokine profiles, and gonadal hormone concentrations to elucidate potential mechanisms. Efficacy will be analyzed using mixed-effects models for repeated measures (MMRM) with prespecified sensitivity analyses for missing data assumptions.
Discussion: This trial represents one of the first rigorous investigations targeting the fatigue-centered symptom cluster as a unified therapeutic endpoint in breast cancer survivors. By combining traditional Chinese herbal medicine with guideline-endorsed behavioral interventions, this study aims to provide high-quality evidence for a novel multi-target treatment strategy. The exploratory biomarker assessments may illuminate the biological mechanisms underlying symptom cluster interrelationships, establishing a foundation for future mechanistic and interventional research in cancer survivorship care.
Clinical trial registration: [ https://itmctr.ccebtcm.org.cn/mgt/project/user/user-project-view/0A267E22-1E0A-4A95-99B0-E5964124F203 ], The International Traditional Medicine Clinical Trial Registry [ITMCTR2025001511].
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BibTeX
@article{li2026shenqi,
title = {{Shenqi Shiyiwei Granule for breast cancer related fatigue-centered symptom cluster: protocol of a multicenter randomized double-blind placebo-controlled trial}},
author = {Si-Yuan Li and Tong-Tong Wu and Yu-Xuan Zhang and Jia Zhao and Jing Hu and Gan-Lin Zhang and Guo-Wang Yang},
journal = {Frontiers in Oncology},
year = {2026},
month = oct,
doi = {10.3389/fonc.2026.1941699},
url = {https://www.frontiersin.org/articles/10.3389/fonc.2026.1941699/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Shenqi Shiyiwei Granule for breast cancer related fatigue-centered symptom cluster: protocol of a multicenter randomized double-blind placebo-controlled trial
AU - Si-Yuan Li
AU - Tong-Tong Wu
AU - Yu-Xuan Zhang
AU - Jia Zhao
AU - Jing Hu
AU - Gan-Lin Zhang
AU - Guo-Wang Yang
PY - 2026
DA - 2026/10/19
JO - Frontiers in Oncology
DO - 10.3389/fonc.2026.1941699
UR - https://www.frontiersin.org/articles/10.3389/fonc.2026.1941699/full
AB - Background: Breast cancer survivors frequently experience fatigue-centered symptom clusters—concurrent, interrelated symptoms including fatigue, pain, and dyspnea—that significantly impair quality of life and functional status. Despite the high prevalence of these symptoms, few interventional trials have targeted symptom clusters as a unified treatment endpoint. Current management relies predominantly on behavioral interventions with inconsistent efficacy, and no pharmacological agent has demonstrated high-quality evidence for cluster-level symptom control in this population. Methods: This multicenter, randomized, double-blind, placebo-controlled trial will enroll 262 postoperative breast cancer survivors (stage I–IIIA) with moderate-to-severe fatigue-centered symptom clusters from 11 hospitals across China. Eligible participants must have completed adjuvant therapy, exhibit an ECOG performance status of 0–1, and present with a MDASI-C fatigue-dyspnea-pain subscale score ≥4. Participants will be randomized 1:1 to receive either Shenqi Shiyiwei Granule or matching placebo for 60 days, with standardized psycho-exercise-dietary guidance provided to all participants throughout a 120-day study period. The primary endpoint is the change from baseline in the fatigue-dyspnea-pain symptom cluster score at 2 months, assessed using the MD Anderson Symptom Inventory-Chinese version (MDASI-C). Secondary endpoints include quality-of-life measures (MFSI-SF, FACT-B, TCM Spleen Qi Deficiency Scale) and cardiopulmonary functional capacity. Exploratory biomarker analyses will evaluate hypothalamic-pituitary-adrenal axis hormones, cytokine profiles, and gonadal hormone concentrations to elucidate potential mechanisms. Efficacy will be analyzed using mixed-effects models for repeated measures (MMRM) with prespecified sensitivity analyses for missing data assumptions. Discussion: This trial represents one of the first rigorous investigations targeting the fatigue-centered symptom cluster as a unified therapeutic endpoint in breast cancer survivors. By combining traditional Chinese herbal medicine with guideline-endorsed behavioral interventions, this study aims to provide high-quality evidence for a novel multi-target treatment strategy. The exploratory biomarker assessments may illuminate the biological mechanisms underlying symptom cluster interrelationships, establishing a foundation for future mechanistic and interventional research in cancer survivorship care. Clinical trial registration: [ https://itmctr.ccebtcm.org.cn/mgt/project/user/user-project-view/0A267E22-1E0A-4A95-99B0-E5964124F203 ], The International Traditional Medicine Clinical Trial Registry [ITMCTR2025001511].
SN - 2234-943X
ER -