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

NCT02331394 | Completed Results

• 1 other identifier: JGH-14-150
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Chinese herbs; lung cancer; quality of life

Outcome Measures

Primary Outcomes (1)

• Feasibility of Using CH for Full-scale Future Research

  Number of participants consented over the total number of approached for the study.

  1 year

Secondary Outcomes (4)

• 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)

  Baseline and 6 weeks

• Physical Well-Being Scores at Baseline and 6 Weeks

  Baseline and 6 weeks

• Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC

  Baseline and 6 weeks

• Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)

  Baseline and 6 weeks

Study Arms (1)

Chinese herbs formula: Shu Yu Wan

EXPERIMENTAL

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.

Dietary Supplement: Chinese herbs formula: Shu Yu Wan

Interventions

Chinese herbs formula: Shu Yu Wan DIETARY_SUPPLEMENT

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.

Also known as: Chinese Yam Pill

Chinese herbs formula: Shu Yu Wan

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

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

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

This is a small study in a single centre leading to small number of subjects Caveat: further randomized controlled study needed to confirm the safety and benefit of of CH formula.

Results Point of Contact

• Title: Goulnar Kasymjanova
• Organization: Jewish General Hospita

gkasymja@jgh.mcgill.ca

514-340-8222

Study Officials

• Thomas Jagoe, MD

  Lady Davis Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a feasibility study designed to see if the main study can be done.

Study Record Dates

• First Submitted: January 3, 2015
• First Posted: January 6, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2019-08-20
• 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)