A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC (CH)

June 11, 2020 updated by: Thomas Jagoe, Lady Davis Institute

A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)

The current proposal is a feasibility and acceptability study to establish the necessary groundwork for more detailed investigations into the role of CH in reducing symptoms and improving quality of life in NSCLC patients at the Jewish General Hospital (JGH). A standardized and easily administered form of CH will be used, incorporating a carefully selected combination of herbs designed to alleviate a range of common symptoms suffered by patients with advanced NSCLC.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with advanced NSCLC, in addition to their very poor chances of cure or extended survival, frequently suffer a range of different symptoms related to both their disease and its treatment. As a result there is a pressing need to develop more effective anti-cancer therapies and an imperative to enhance the effects of existing treatments and alleviate symptoms more effectively.

Increasing numbers of patients with cancer are using complementary medicine, including Chinese herbs (CH), and evidence is accumulating from a growing number of laboratory studies and clinical trials, that CH may exert beneficial effects for cancer patients in many ways.

The current proposal is a feasibility and acceptability study to establish the necessary groundwork for more detailed investigations into the role of CH in reducing symptoms and improving quality of life in NSCLC patients at the JGH. A standardized and easily administered form of CH will be used, incorporating a carefully selected combination of herbs designed to alleviate a range of common symptoms suffered by patients with advanced NSCLC.

This is a prospective, longitudinal cohort study of a 6-week clinical intervention with Chinese herbs in advanced (Stage 4) NSCLC patients All the active patients who have histologically or cytologically proven metastatic NSCLC with Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2 will be eligible to participate in the study. Quality of life will be assessed by FACT-L and Edmonton Symptom Assessment System (ESAS) questionnaires. Patient will be instructed to complete a diary each day to confirm adherence to treatment and to indicate the reason(s) that any doses were missed or treatment was stopped.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Peter Brojge Lung Cancer Center, Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stages 4
  • ECOG performance ≤ 3
  • Life expectancy greater than ≥ 3 months

Exclusion Criteria:

  • Receiving Tyrosine Kinase Inhibitors (TKI), (Tarceva, Iressa)
  • Brain metastases
  • Patients or families who do not speak English or French
  • Abnormal liver function: Alanine aminotransaminase (ALT) > 40 U/L, Aspartate aminotransaminase (AST) > 55 U/L, Alkaline phosphatase (ALP) > 145 U/L , Bilirubin > 1.7 umol/L.
  • Taking regular anti-convulsants, Coumadin or related anti-coagulant, lithium
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chinese herbs formula: Shu Yu Wan
All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard care. This study will use the Shu Yu Wan formula which comprises 23 different herbs and is based on the best evidence in the literature of use of CH in lung cancer.
The patients will be offered the choice of taking the CH formula in capsules or sachets and given instructions about recommendations to improve palatability. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks.
Other Names:
  • Chinese Yam Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Using CH for Full-scale Future Research
Time Frame: 1 year
Number of participants consented over the total number of approached for the study.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QOL From Baseline on the 36 Items Functional Assessment of Cancer Therapy - Lung (FACT-L) at the End of the Study (Week 6)
Time Frame: Baseline and 6 weeks
Functional Assessment of Cancer Therapy - Lung (FACT-L) is a 36-item self-assessment questionnaire that measures QOL over the past week in patients with lung cancer. The FACT-L is made up of five subscales of question rated on a five-point Likert scale and include physical well-being (PWB, range of scores is 0-28), social/family well-being (SWB, range of scores is 0-28), emotional well-being (EWB, range of scores is 0-24), functional well-being (FWB, range of scores is 0-28), and symptoms of lung cancer scale (LCS, range of scores is 0-36). For all subscales higher score is better. A total overall score (0-144). Alternative scoring includes the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, and Lung Cancer Subscales. Total score ranges from 0-92 with high score being better. The clinically meaningful changes of this measure is 6 points. Unit measure is scores on a scales.
Baseline and 6 weeks
Physical Well-Being Scores at Baseline and 6 Weeks
Time Frame: Baseline and 6 weeks
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. Effect size (ES) of this study based on magnitude difference of PWB scale of the FACT-L between two measures (baseline and 6 weeks). This ES will be used to calculate sample size in Phase 2 study
Baseline and 6 weeks
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC
Time Frame: Baseline and 6 weeks
Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
Baseline and 6 weeks
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)
Time Frame: Baseline and 6 weeks
The Edmonton Symptom Assessment System (ESAS) is a valid and reliable assessment tool to assist in the assessment of common symptoms experienced by cancer patients including: sleep, well-being, pain, strength, appetite, nausea, vomiting, constipation, drowsiness, tiredness, shortness of breath, depression, anxiety, and distress. Each symptom is rated from 0 to 10 cm on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas Jagoe, MD, Lady Davis Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

January 3, 2015

First Submitted That Met QC Criteria

January 3, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication in peer-reviewed journal

IPD Sharing Time Frame

2019-08-20

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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