Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-89
SponsorChinese University of Hong Kong
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Yunzhi Essence
DrugYunzhi Essence capsule
Placebo
Other interventionPlacebo capsules
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: Active treatment (Yunzhi Essence)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 monthsSecondary outcomes
1
Survival rate
Survival rate will be measured from baseline to month 6
Time frame
From baseline to 6 months2
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.
Time frame
4 months3
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.
Time frame
6 months4
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.
Time frame
4 monthsSponsors and contacts
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Source ClinicalTrials.gov