Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062299) titled 'An Exploratory Study of Cirsium brevicaule Supplement in Cancer Patients' on July 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Ageo Central General Hospital

Condition: Condition - Malignant Neoplasms (Cancer) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this single-arm exploratory study is to evaluate the effects of daily intake of Cirsium brevicaule-derived health food on quality of life (QOL), inflammatory, immunological, and metabolic markers, as well as plasma proteomic profiles in cancer patients, and to assess its potential efficacy and safety. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Oral administration of Cirsium brevicaule-derived health food (2 packets daily) for 3 months (12 weeks).

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Male or female patients aged 20 years or older at the time of providing written informed consent. 2.Histologically or cytologically confirmed solid tumor or hematological malignancy. 3.Patients currently receiving, scheduled to receive standard anti-cancer therapy, or receiving palliative/supportive care without active anti-cancer treatment. 4.ECOG Performance Status (PS) of 0 to 2. 5.Adequate major organ function (hepatic, renal, bone marrow, etc.) determined by the primary physician as sufficient for safe participation in this study. 6.Capable of oral ingestion and expected to be compliant with the daily study food intake (twice daily). 7.Voluntarily provided written informed consent after receiving a full explanation of the study details using the informed consent document. Key exclusion criteria - 1.History of allergy to Cirsium brevicaule (Shimami Azami), Asteraceae family plants, or any components of the study food. 2.Patients participating in other clinical trials at the time of study initiation. 3.Patients with severe comorbidities deemed inappropriate for participation by the primary physician, such as severe hepatic impairment, renal impairment, heart failure, or uncontrolled diabetes. 4.Pregnant, lactating, or planning to become pregnant. 5.Patients otherwise judged by the principal investigator to be unsuitable for participation in this study. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 08 Day Date of IRB - 2026 Year 07 Month 24 Day Anticipated trial start date - 2026 Year 07 Month 27 Day Last follow-up date - 2026 Year 12 Month 21 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071278

Disclaimer: Curated by HT Syndication.