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

NCT ID: NCT05754801

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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Cancer Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active treatment (Yunzhi Essence)

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

Group Type EXPERIMENTAL

Yunzhi Essence

Intervention Type DRUG

Yunzhi Essence capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsules

Interventions

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Yunzhi Essence

Yunzhi Essence capsule

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type OTHER

Other Intervention Names

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Yunzhi

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Prof. Lin Zhixiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhixiu Lin

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Institute of Integrative Medicine

Central Contacts

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Cho Wing Lo

Role: CONTACT

Other Identifiers

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Yunzhi study

Identifier Type: -

Identifier Source: org_study_id

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