NCT02331394

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Lady Davis Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chinese herbs formula: Shu Yu Wan	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2015-01-06
• Last updated: 2020-06-23
• Results posted: 2020-06-23

Locations

1 site across 1 country: Canada