Clinical trial NCT05754801: Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer
Official title: Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer: A Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cancer
Palliative Care
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 172
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Score change of McGilll QOL-Hong Kong
timeFrame: 6 months
Secondary outcomes:
measure: Survival rate
timeFrame: From baseline to 6 months
measure: Changes in immunological levels
timeFrame: 4 months
measure: Changes in immunological levels
timeFrame: 6 months
measure: Changes in tumor marker level
timeFrame: 4 months
measure: Changes in tumor marker level
timeFrame: 6 months
measure: Score change of Edmonton Symptom Assessment System (ESAS)
timeFrame: 6 months
measure: Use of rescue pain medication
timeFrame: From baseline to 6 months
measure: Number of interventional medical treatments
timeFrame: From baseline to 6 months
measure: Level change of total bilirubin
timeFrame: From baseline to 6 months
measure: Level change of Alkaline Phosphatase (ALP)
timeFrame: From baseline to 6 months
measure: Level change of Alanine Transaminase (ALT)
timeFrame: From baseline to 6 months
measure: Level change of Aspartate Transferase (AST)
timeFrame: From baseline to 6 months
measure: Level change of Gamma-glutamyl Transferase (GGT)
timeFrame: From baseline to 6 months
measure: Level change of Creatinine
timeFrame: From baseline to 6 months
measure: Level change of Sodium
timeFrame: From baseline to 6 months
measure: Level change of Potassium
timeFrame: From baseline to 6 months
measure: Level change of Blood urea nitrogen (BUN)
timeFrame: From baseline to 6 months
measure: Level change of Uric acid
timeFrame: From baseline to 6 months
measure: Level change of blood markers
timeFrame: From baseline to 6 months
measure: Change of urine analysis
timeFrame: 2 months
measure: Change of urine analysis
timeFrame: 4 months
measure: Change of urine analysis
timeFrame: 6 months
measure: Change in body weight
timeFrame: From baseline to 6 months
measure: Number of oral ulcer
timeFrame: From baseline to 6 months
measure: Change in Chinese medicine symptom score
timeFrame: 2 months
measure: Change in Chinese medicine symptom score
timeFrame: 4 months
measure: Change in Chinese medicine symptom score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Institute of Integrative Medicine
name: Zhixiu Lin
role: PRINCIPAL_INVESTIGATOR
References: