Clinical Evaluation of the Tiaoshen Anti-Cancer Regimen in Treating Psycho-Neurological Symptom Cluster in Ovarian Cancer

The academic community generally believes that cancer symptom clusters (CSCs) are not independent diseases, but a group of symptoms that accompany cancer patients. Based on etiology, they can be classified into CSCs related to tumor progression, CSCs related to cancer treatment, or a combination of both. According to symptom manifestations, they can be divided into psychological symptom CSCs, somatic symptom CSCs, and CSCs with coexisting psychological and somatic symptoms. CSCs are universally present during the progression or treatment of cancer. Traditional Chinese medicine (TCM) can leverage its unique characteristics in the intervention of symptom clusters and symptom management. This study is planned to conduct a high-level, prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a TCM regimen for cancer symptom clusters (CSCs), and to simultaneously analyze the characteristics of the population that may benefit most from TCM treatment for CSCs.

NCT Number	NCT07050563
Lead Sponsor	Shanghai Municipal Hospital of Traditional Chinese Medicine Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Qinghai University, Obstetrics & Gynecology Hospital of Fudan University, Fudan University, Beijing Hospital of Traditional Chinese Medicine
Conditions	Cancer, Cancer Symptom Clusters
Enrollment	316 participants
Start Date	2025-10-06
Primary Completion	2028-09-01 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-29