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

Lady Davis Institute

Status: Completed

Conditions: Lung Cancer

Treatments: Dietary Supplement: Chinese herbs formula: Shu Yu Wan

Study type: Interventional

Funder types: Other

Identifiers

NCT02331394

JGH-14-150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Chinese herbs formula: Shu Yu Wan

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Chinese herbs formula: Shu Yu Wan