Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer

Trial Title: Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer

NCT ID: NCT05754801

Condition: Cancer
Palliative Care

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Yunzhi Essence
Description: Yunzhi Essence capsule
Arm group label: Active treatment (Yunzhi Essence)

Other name: Yunzhi

Intervention type: Other
Intervention name: Placebo
Description: Placebo capsules
Arm group label: Placebo

Summary: A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine 'Coriolus Versicolor for improving the quality of life of patients with advanced-stage cancer. Subjects will be randomized into a treatment group or placebo group for 6 months.

Detailed description: According to the Compendium of Materia Medica, a classic encyclopedia for Chinese medicines written by the venerated Physician Li ShiZhen of the Ming dynasty, Yunzhi (Coriolus Versicolor) is treasured as a superbly valuable herb as it not only can strengthen and consolidate the body's resistance, as well as reinforce and nourish a person's marrow and kidney essence and also is harmless to patients. Recent research found that the extract from Yunzhi, named as polysaccharide-peptide (PSP), could inhibit the growth of human hematoma cell line & sarcoma and was proved to have direct anti-cancer effects. Quality of life (QOL) of patients is the ultimate goal of palliative care as endorsed by the World Health Organization (WHO) in 1990. When survival is limited in advanced incurable diseases, quality of life is most important. Patients with advanced cancer (palliative) often manifest numerous physical and psychological symptoms and a poor quality of life. While maintenance of the quality of life of advanced cancer patients is important, the physical dimension of quality of life still needs improvement, especially in the palliative stage. To date, there is no specific supportive Traditional Chinese Medicine(TCM)-related products that have been proven in randomized controlled trials for alleviating these debilitating symptoms and improving their quality of life. The present study aims to scientifically evaluate whether a Yunzhi product named G.E. Yunzhi-Essence is effective and safe in improving the QOL of palliative patients with advanced cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Diagnosed with advanced cancer according to the definition from American Cancer Society; - According to the experience of the doctor, by using Palliative Prognostic Index (score>4), integrated with past cases and professional knowledge judged to have life expectancy not less than six months to two years; - Abbreviated mental test (AMT) score of 6 or above; - Voluntarily participate in this clinical trial and sign the informed consent form (acceptance of close relatives signed informed consent on behalf of the patient); - Refer to the national standard for Clinic terminology of traditional Chinese medical diagnosis and treatment-Part 2:Syndromes/patterns, syndrome of "damp heat spleen" and "spleen deficiency with water stop" (Fulfill 2 of the main symptoms and 2 of the secondary symptoms). Exclusion Criteria: - Patients with a history of allergy to traditional Chinese medicine or Yunzhi; - Patients who required nasal feeding or difficulty swallowing; - Patients with comatose/semi-conscious, cognitively impaired with dementia/confusion, physically too ill with extremely poor general condition, or there was a language barrier.

Gender: All

Minimum age: 21 Years

Maximum age: 89 Years

Healthy volunteers: No

Start date: April 1, 2023

Completion date: September 30, 2026

Lead sponsor:
Agency: Chinese University of Hong Kong
Agency class: Other

Source: Chinese University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05754801