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

July 28, 2026 updated by: Prof. Lin Zhixiu, Chinese University of Hong Kong

Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer: A Randomized, Double-blinded, Placebo-controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • School of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active treatment (Yunzhi Essence)
Subjects will take 2 Yunzhi capsules, 4 times daily, for 6 months.
Drug: Yunzhi Essence
Yunzhi Essence capsule
Other Names:
  • Yunzhi
Placebo Comparator: Placebo
Subjects will take 2 placebo capsules, 4 times daily, for 6 months
Other: Placebo
Placebo capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score change of McGilll QOL-Hong Kong
Time Frame: 6 months
McGill QOL-Hong Kong questionnaire will be used to measure the quality of life of subjects. It consists of 16 items and also a single item rating the overall QOL. All the response categories are based on a numerical scale from 0 to 10, with verbal anchors at the ends of the scale. The higher the score, the better the quality of life.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: From baseline to 6 months
Survival rate will be measured from baseline to month 6
From baseline to 6 months
Changes in immunological levels
Time Frame: 4 months
T Serum immunoglobulins levels such as immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) are key immunological markers for the humoral immune status. The levels of IgA, IgG and IgM are determined routinely in clinical practice to give the doctors important information about the immune system function, especially relating to infection or autoimmune diseases.
4 months
Changes in immunological levels
Time Frame: 6 months
T Serum immunoglobulins levels such as immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) are key immunological markers for the humoral immune status. The levels of IgA, IgG and IgM are determined routinely in clinical practice to give the doctors important information about the immune system function, especially relating to infection or autoimmune diseases.
6 months
Changes in tumor marker level
Time Frame: 4 months

When cancer occurs, a substance called "tumor marker" will appear in the body. It may be a by-product of cancer cells or the body's response to the tumor. Most tumor markers are proteins that can be detected in blood or urine come out. Tumor markers help to determine the possibility of cancer in some patients. One of the most important uses of tumor markers is to monitor the progress of patients during treatment.

The blood sample will be taken for measuring the tumor marker on month 4.
4 months
Changes in tumor marker level
Time Frame: 6 months

When cancer occurs, a substance called "tumor marker" will appear in the body. It may be a by-product of cancer cells or the body's response to the tumor. Most tumor markers are proteins that can be detected in blood or urine come out. Tumor markers help to determine the possibility of cancer in some patients. One of the most important uses of tumor markers is to monitor the progress of patients during treatment.

The blood sample will be taken for measuring the tumor marker on month 6.
6 months
Score change of Edmonton Symptom Assessment System (ESAS)
Time Frame: 6 months
The ESAS includes 11 common patient symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and "other". It uses a 0-10 numerical scale: 0 indicates the absence of a symptom, and 10 indicates the worst experience of the symptom.
6 months
Use of rescue pain medication
Time Frame: From baseline to 6 months
Number of rescue pain medication will be record during the study period
From baseline to 6 months
Number of interventional medical treatments
Time Frame: From baseline to 6 months
Total number of interventional medical treatment will be records during the study period
From baseline to 6 months
Level change of total bilirubin
Time Frame: From baseline to 6 months
Blood samples will be taken for Liver function test(LFT). Total bilirubin will be measured.
From baseline to 6 months
Level change of Alkaline Phosphatase (ALP)
Time Frame: From baseline to 6 months
Blood samples will be taken for Liver function test(LFT). Alkaline Phosphatase (ALP) will be measured.
From baseline to 6 months
Level change of Alanine Transaminase (ALT)
Time Frame: From baseline to 6 months
Blood samples will be taken for Liver function test(LFT). Alanine Transaminase (ALT) will be measured.
From baseline to 6 months
Level change of Aspartate Transferase (AST)
Time Frame: From baseline to 6 months
Blood samples will be taken for Liver function test(LFT). Aspartate Transferase (AST) will be measured.
From baseline to 6 months
Level change of Gamma-glutamyl Transferase (GGT)
Time Frame: From baseline to 6 months
Blood samples will be taken for Liver function test(LFT). Gamma-glutamyl Transferase (GGT) will be measured.
From baseline to 6 months
Level change of Creatinine
Time Frame: From baseline to 6 months
Blood samples will be taken for Renal function test (RFT). Creatinine will be measured.
From baseline to 6 months
Level change of Sodium
Time Frame: From baseline to 6 months
Blood samples will be taken for Renal function test (RFT). Sodium will be measured.
From baseline to 6 months
Level change of Potassium
Time Frame: From baseline to 6 months
Blood samples will be taken for Renal function test (RFT). Potassium will be measured.
From baseline to 6 months
Level change of Blood urea nitrogen (BUN)
Time Frame: From baseline to 6 months
Blood samples will be taken for Renal function test (RFT). Blood urea nitrogen (BUN) will be measured.
From baseline to 6 months
Level change of Uric acid
Time Frame: From baseline to 6 months
Blood samples will be taken for Renal function test (RFT). Uric acid will be measured.
From baseline to 6 months
Level change of blood markers
Time Frame: From baseline to 6 months
Blood samples will be taken for Complete blood count (CBC)
From baseline to 6 months
Change of urine analysis
Time Frame: 2 months
Urine sample will be taken for urine protein analysis.
2 months
Change of urine analysis
Time Frame: 4 months
Urine sample will be taken for urine protein analysis.
4 months
Change of urine analysis
Time Frame: 6 months
Urine sample will be taken for urine protein analysis.
6 months
Change in body weight
Time Frame: From baseline to 6 months
Body weight will be measure during each visit
From baseline to 6 months
Number of oral ulcer
Time Frame: From baseline to 6 months
Total number of oral ulcer during study period
From baseline to 6 months
Change in Chinese medicine symptom score
Time Frame: 2 months

Chinese medicine practitioners will assess subjects' symptoms in month 2, the symptoms such as bloating, less appetite, fatigue and defecation.

The symptoms will be scored on a scale of 0,2,4,6, which represents none, mild, moderate and severe respectively. A higher score means a worse outcome.
2 months
Change in Chinese medicine symptom score
Time Frame: 4 months

Chinese medicine practitioners will assess subjects' symptoms in month 4, the symptoms such as bloating, less appetite, fatigue and defecation.

The symptoms will be scored on a scale of 0,2,4,6, which represents none, mild, moderate and severe respectively. A higher score means a worse outcome.
4 months
Change in Chinese medicine symptom score
Time Frame: 6 months

Chinese medicine practitioners will assess subjects' symptoms in month 6, the symptoms such as bloating, less appetite, fatigue and defecation.

The symptoms will be scored on a scale of 0,2,4,6, which represents none, mild, moderate and severe respectively. A higher score means a worse outcome.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhixiu Lin, Hong Kong Institute of Integrative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Yunzhi study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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