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

NCT05754801 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Yunzhi study
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer; Palliative Care

Outcome Measures

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.

  6 months

Secondary Outcomes (27)

• Survival rate

  From baseline to 6 months

• Changes in immunological levels

  4 months

• Changes in immunological levels

  6 months

• Changes in tumor marker level

  4 months

• Changes in tumor marker level

  6 months

Study Arms (2)

Active treatment (Yunzhi Essence)

EXPERIMENTAL

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

Drug: Yunzhi Essence

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Yunzhi Essence DRUG

Yunzhi Essence capsule

Also known as: Yunzhi

Active treatment (Yunzhi Essence)

Placebo OTHER

Placebo capsules

Placebo

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zhixiu Lin

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: March 6, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 9, 2023

Record last verified: 2023-03