CancerPhase 2NCT05754801
Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer
A Phase 2 study testing Yunzhi Essence in people with Cancer and Palliative Care, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Cancer, Palliative Care
- What is being tested?
- Yunzhi Essence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jan 2024to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Chinese Medicine
Hong Kong
Prof. Lin, 852-28733252, linzx@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Palliative Care
- Being tested
- Yunzhi Essence, Placebo
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yunzhi EssenceDrug
Also called Yunzhi
Yunzhi Essence capsule
PlaceboOther
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (Yunzhi Essence) | Experimental | Subjects will take 2 Yunzhi capsules, 4 times daily, for 6 months. Receives: Drug: Yunzhi Essence |
| Placebo | Placebo comparator | Subjects will take 2 placebo capsules, 4 times daily, for 6 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change of McGilll QOL-Hong Kong
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.
Measured: 6 months
Secondary outcomes (27)
Survival rate
Survival rate will be measured from baseline to month 6
Measured: From baseline to 6 months
Changes in immunological levels
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.
Measured: 4 months
Changes in immunological levels
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.
Measured: 6 months
Changes in tumor marker level
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.
Measured: 4 months
Changes in tumor marker level
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.
Measured: 6 months
Score change of Edmonton Symptom Assessment System (ESAS)
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.
Measured: 6 months
Use of rescue pain medication
Number of rescue pain medication will be record during the study period
Measured: From baseline to 6 months
Number of interventional medical treatments
Total number of interventional medical treatment will be records during the study period
Measured: From baseline to 6 months
Level change of total bilirubin
Blood samples will be taken for Liver function test(LFT). Total bilirubin will be measured.
Measured: From baseline to 6 months
Level change of Alkaline Phosphatase (ALP)
Blood samples will be taken for Liver function test(LFT). Alkaline Phosphatase (ALP) will be measured.
Measured: From baseline to 6 months
Level change of Alanine Transaminase (ALT)
Blood samples will be taken for Liver function test(LFT). Alanine Transaminase (ALT) will be measured.
Measured: From baseline to 6 months
Level change of Aspartate Transferase (AST)
Blood samples will be taken for Liver function test(LFT). Aspartate Transferase (AST) will be measured.
Measured: From baseline to 6 months
Level change of Gamma-glutamyl Transferase (GGT)
Blood samples will be taken for Liver function test(LFT). Gamma-glutamyl Transferase (GGT) will be measured.
Measured: From baseline to 6 months
Level change of Creatinine
Blood samples will be taken for Renal function test (RFT). Creatinine will be measured.
Measured: From baseline to 6 months
Level change of Sodium
Blood samples will be taken for Renal function test (RFT). Sodium will be measured.
Measured: From baseline to 6 months
Level change of Potassium
Blood samples will be taken for Renal function test (RFT). Potassium will be measured.
Measured: From baseline to 6 months
Level change of Blood urea nitrogen (BUN)
Blood samples will be taken for Renal function test (RFT). Blood urea nitrogen (BUN) will be measured.
Measured: From baseline to 6 months
Level change of Uric acid
Blood samples will be taken for Renal function test (RFT). Uric acid will be measured.
Measured: From baseline to 6 months
Level change of blood markers
Blood samples will be taken for Complete blood count (CBC)
Measured: From baseline to 6 months
Change of urine analysis
Urine sample will be taken for urine protein analysis.
Measured: 2 months
Change of urine analysis
Urine sample will be taken for urine protein analysis.
Measured: 4 months
Change of urine analysis
Urine sample will be taken for urine protein analysis.
Measured: 6 months
Change in body weight
Body weight will be measure during each visit
Measured: From baseline to 6 months
Number of oral ulcer
Total number of oral ulcer during study period
Measured: From baseline to 6 months
Change in Chinese medicine symptom score
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.
Measured: 2 months
Change in Chinese medicine symptom score
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.
Measured: 4 months
Change in Chinese medicine symptom score
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start5 Jan 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754801
- Sponsor's protocol ID
- Yunzhi study
- Status last verified
- Jul 2026
- First submitted
- 28 Dec 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer: A Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05754801
- Acronym / sponsor ID
- Yunzhi study
- Conditions
- Cancer, Palliative Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment (Yunzhi Essence) | Experimental | Drug: Yunzhi EssenceSubjects will take 2 Yunzhi capsules, 4 times daily, for 6 months. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will take 2 placebo capsules, 4 times daily, for 6 months |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yunzhi EssenceAlso: YunzhiYunzhi Essence capsule | Drug | Active treatment (Yunzhi Essence) |
| PlaceboPlacebo capsules | Other | Placebo |
Primary outcome
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.
27 secondary outcomes
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
Level change of Gamma-glutamyl Transferase (GGT)
Time frame: From baseline to 6 months
Level change of Creatinine
Time frame: From baseline to 6 months
Level change of Sodium
Time frame: From baseline to 6 months
Level change of Potassium
Time frame: From baseline to 6 months
Level change of Blood urea nitrogen (BUN)
Time frame: From baseline to 6 months
Level change of Uric acid
Time frame: From baseline to 6 months
Level change of blood markers
Time frame: From baseline to 6 months
Change of urine analysis
Time frame: 2 months
Change of urine analysis
Time frame: 4 months
Change of urine analysis
Time frame: 6 months
Change in body weight
Time frame: From baseline to 6 months
Number of oral ulcer
Time frame: From baseline to 6 months
Change in Chinese medicine symptom score
Time frame: 2 months
Change in Chinese medicine symptom score
Time frame: 4 months
Change in Chinese medicine symptom score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhixiu Lin principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yunzhi Essence in people with Cancer and Palliative Care, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cho Wing Lo (35053476, louislo@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change of McGilll QOL-Hong Kong (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.