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NCT Number: NCT05754801

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

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.

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Key information

Conditions

Cancer Neoplasms Palliative Care

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yunzhi Essence

Drug

Yunzhi Essence capsule

Other names: Yunzhi

Placebo

Other

Placebo capsules

Primary outcomes

  1. 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.

Secondary outcomes

  1. Survival rate

    Time frame: From baseline to 6 months

    Survival rate will be measured from baseline to month 6

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. Use of rescue pain medication

    Time frame: From baseline to 6 months

    Number of rescue pain medication will be record during the study period

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Level change of blood markers

    Time frame: From baseline to 6 months

    Blood samples will be taken for Complete blood count (CBC)

  20. Change of urine analysis

    Time frame: 2 months

    Urine sample will be taken for urine protein analysis.

  21. Change of urine analysis

    Time frame: 4 months

    Urine sample will be taken for urine protein analysis.

  22. Change of urine analysis

    Time frame: 6 months

    Urine sample will be taken for urine protein analysis.

  23. Change in body weight

    Time frame: From baseline to 6 months

    Body weight will be measure during each visit

  24. Number of oral ulcer

    Time frame: From baseline to 6 months

    Total number of oral ulcer during study period

  25. 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.

  26. 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.

  27. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cho Wing Lo

CONTACT

[email protected]

35053476

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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