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

The Chinese University of Hong Kong

Status and phase: Not yet enrolling; Phase 2

Conditions: Cancer; Palliative Care

Treatments: Other: Placebo; Drug: Yunzhi Essence

Study type: Interventional

Funder types: Other

Identifiers

NCT05754801

Yunzhi study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups, including a placebo group

Active treatment (Yunzhi Essence)

Experimental group

Description:

Subjects will take 2 Yunzhi capsules, 4 times daily, for 6 months.

Treatment:

Drug: Yunzhi Essence

Placebo

Placebo Comparator group

Description:

Subjects will take 2 placebo capsules, 4 times daily, for 6 months

Treatment:

Other: Placebo