Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Physical Well-Being Scores at Baseline and 6 Weeks
研究概览
简要总结
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.
详细描述
Despite advances in the design and administration of anti-cancer therapies over recent years, the overall 5-year survival rate for patients with advanced stage lung cancer is 2-4%. These patients frequently suffer a range of different symptoms related to both their disease and it's treatment. As a result, there is a pressing need for research into treatments that may improve their symptoms as well as their quality of life (QOL).
An increasing body of evidence suggests that complementary medicine, including carefully selected combinations of Chinese Herbs (CH), may exert beneficial effects for cancer patients in many ways. The literature suggests that CH combined with chemotherapy can improve survival rates, immediate tumor response, performance status and QOL for those with locally advanced and metastatic disease.
The Shu Yu Wan (SYW) formula used in the feasibility study which demonstrated a significant improvement in symptoms and quality of life will also be employed in this interventional study. THe SYW formula consists of 23 natural Chinese herbs.
This is a randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio for investigating the efficacy and safety of SYW formula for the treatment of lung cancer symptoms. Patients in both groups will receive formula or placebo at a fixed dose for 6 weeks.
After completion of study medication, the treatment will be unblinded and patients randomized to placebo will be offered to cross-over to SYW and will repeat visits Week 0 & Week 6. Patients will be closely monitored for safety and tolerability throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •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
排除标准
- •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.
结局指标
主要结局
Physical Well-Being Scores at Baseline and 6 Weeks
时间窗: 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.
次要结局
- Fatigue scores at Baseline and 6 weeks(Baseline and 6 weeks)
研究者
Thomas Jagoe
Co-Director Peter Brojde Lung Cancer Centre, Jewish General Hospital
Lady Davis Institute