Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yunzhi Essence, Placebo.
- Who it may be relevant to
- Registry conditions: Cancer, Palliative Care. Basic parameters: 21 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer: A Randomized, Double-blinded, Placebo-controlled Trial
Overview
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.
Interventions
- Drug Yunzhi Essence
Yunzhi Essence capsule - Other Placebo
Placebo capsules
Primary outcome measures
- Score change of McGilll QOL-Hong Kong [Time frame: 6 months]
Secondary outcome measures (12)
- Survival rate [Time frame: From baseline to 6 months]
- Changes in immunological levels [Time frame: 4 months]
- Changes in immunological levels [Time frame: 6 months]
- Changes in tumor marker level [Time frame: 4 months]
- Changes in tumor marker level [Time frame: 6 months]
- Score change of Edmonton Symptom Assessment System (ESAS) [Time frame: 6 months]
- Use of rescue pain medication [Time frame: From baseline to 6 months]
- Number of interventional medical treatments [Time frame: From baseline to 6 months]
- Level change of total bilirubin [Time frame: From baseline to 6 months]
- Level change of Alkaline Phosphatase (ALP) [Time frame: From baseline to 6 months]
- Level change of Alanine Transaminase (ALT) [Time frame: From baseline to 6 months]
- Level change of Aspartate Transferase (AST) [Time frame: From baseline to 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Hong Kong · 1 center
- School of Chinese Medicine — Hong Kong
Identifiers
NCT: NCT05754801 · Yunzhi study