Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients

NCT04615884 | Withdrawn

• 1 other identifier: CH:II
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether Chinese Herb supplements lead to a measurable improvement in symptoms commonly experienced by patients with advanced stage lung cancer and an improvement in quality of life. In our previously conducted single-arm observational study we found significant improvement in physical well-being, tiredness and drowsiness with no evidence of increased toxicity even in those on cytotoxic chemotherapy. Based on the encouraging results of this study we plan to move to a placebo-controlled study using the same Chinese Herb formula.

Conditions

Metastatic NSCLC

Keywords

NSCLC, Metastatic, Symptom management,

Outcome Measures

Primary Outcomes (1)

• Physical Well-Being Scores at Baseline and 6 Weeks

  The primary objective is to compare the change in patient reported Physical Well-Being (PWB) subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. The Physical well-being (PWB) subscale has 7 questions with the range of the score from 0 to 4 each. The range of the total score is 0 to 28. The higher the score the better the physical well-being.

  Baseline and 6 weeks

Secondary Outcomes (1)

• Fatigue scores at Baseline and 6 weeks

  Baseline and 6 weeks

Study Arms (2)

Chinese herbs formula: Shu Yu Wan

EXPERIMENTAL

Participants will receive Shu Yu Wan capsules, to take 3 times daily for 6 weeks.

Dietary Supplement: Chinese herbs formula: Shu Yu Wan

Placebo

PLACEBO COMPARATOR

Participants will receive capsules to take 3 times daily for 6 weeks.

Other: Placebo capsules

Interventions

Chinese herbs formula: Shu Yu Wan DIETARY_SUPPLEMENT

Shu Yu Wan Formula is a combination of 23 natural chinese herbs.This formula may be used to relieve chemotherapeutic side effects or cancer-related symptoms.

Chinese herbs formula: Shu Yu Wan

Placebo capsules OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients must meet the following criteria for study entry:
• Signed informed consent
• Ability to comply with protocol
• Aged ≥18 years
• Histologically or cytologically documented metastatic NSCLC (American Joint Committee on Cancer \[AJCC\] staging system)
• Prior chemotherapy or radiotherapy is allowed provided the patient has recovered from any toxic effects
• Either off chemotherapy with no plans to start within the next 8 weeks OR on first or second line systemic anti-cancer treatment for NSCLC and completed at least 1 cycle of their current treatment prior to randomization. Permitted chemotherapy regimens are: standard systemic chemotherapy, targeted therapy, immunotherapy or any combinations of the three
• Karnofsky performance status of ≥60
• Life expectancy ≥ 12 weeks
• Adequate hematologic and end-organ function defined by the following laboratory results obtained within 14 days prior to the first study eligibility):
• ANC 1. 3 -3.5 x\^109/L WBC counts 4.0 - 11 x\^109/L Platelet count 150 - 400 x\^109/L Hemoglobin 90 -150 g/dL Liver function tests AST ≤ 1.5 x ULN / ALT ≤ 1.5 x ULN L Serum bilirubin 3.0-17.0 x U/L INR ≤1.5 x ULN Creatinine clearance 50-120 mL/min

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study entry:
• Active or untreated central nervous system metastases
• Uncontrolled pleural effusion
• Patients or families who do not speak English or French
• Abnormal liver function as defined above
• Taking regular anti-convulsants, Coumadin or related anti-coagulant
• Taking regular immunosuppressive medications: azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), or other immunosuppressive or anti-coagulant that metabolized by liver.

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Peter Brojge Lung Cancer Center, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Peter Brojde Lung Cancer Centre, Jewish General Hospital

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: March 2024, For 10 years.
• Access Criteria: 1\. Kasymjanova G, Tran AT, Cohen V, Pepe C, Sakr L, Small D, Agulnik JS, Jagoe RT: The use of a standardized Chinese herbal formula in patients with advanced lung cancer: a feasibility study. Journal of integrative medicine 2018, 16(6):390-395.

Locations

CA (1)