A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of Traditional Chinese Medicine Formula LC09 for Treatment of Capecitabine-Induced Hand and Foot Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 主要终点
- Assessment of patient reported pain using a 1-10 score.
研究概览
简要总结
RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast cancer.
PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for colorectal or breast cancer.
详细描述
OBJECTIVES:
OBJECTIVES: Determine whether Traditional Chinese Medicine Formula LC09 can treat or reduce the severity of capecitabine-caused hand foot syndrome.
Evaluate the potential toxicity of Traditional Chinese Medicine Formula LC09. OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are randomized to 2 treatment arms.
Arm I: Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
Arm II: Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria to be eligible for the study:
- •Histologically confirmed colorectal cancer or breast cancer, of which colorecta cancer is advanced or undergoing adjuvant therapy after radical resection and breast cancer is at the stage of recurrence or metastasis;
- •Level 1 or above HFS after receiving capecitabine as part of routine standard care;
- •Plan to receive capecitabine as part of routine more than 2 weeks;
- •ECOG performance status 0-2;
- •Life expectancy greater than or equal to 3 months;
- •No serious heart, liver, kidney and other important viscera dysfunction, as defined below:
- •absolute neutrophil count greater than or equal to 1.5 x 10(9)/L
- •platelet count greater than or equal to 100 x 10(9)/L
- •hemoglobin greater than or equal to 9.0 g/dL
- •total bilirubin less than or equal to 1.5 times the ULN
- •AST/SGOT and ALT/SGPT less than or equal to 2.5 times the ULN (or less than or equal to 5 times the ULN if liver function abnormalities due to underlying malignancy)
- •creatinine less than or equal to 1.5 times the ULN
- •creatinine clearance greater than or equal to 60 ml/min (by Cockcroft-Gault)
- •Ability to cooperate with HFS grade evaluation, understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects meeting any of the following criteria are ineligible for study entry:
- •Concurrent with level 1 or above peripheral neuropathy (such as diabetic neuropathy or chemotherapy induced peripheral neuropathy);
- •Other acute or chronic inflammatory conditions or infections of the hands or feet that would complicate safety, application of topical creams, or study endpoints;
- •Currently taking other treatment for PPE (including topical urea cream, pyridoxine, celecoxib, compound matrine injection and deproteinized calf blood extractive injection);
- •History of severe or uncontrolled organic disease or infection, such as heart, pulmonary or renal failure that cause the termination of chemotherapy;
- •Pregnant (positive pregnancy test) or nursing women;
- •Participating in other clinical trial currently or within 4 weeks.
研究组 & 干预措施
Arm I
Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
干预措施: Traditional Chinese Medicine Formula LC09 (Drug)
Arm II
Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
干预措施: Placebo (Other)
结局指标
主要结局
Assessment of patient reported pain using a 1-10 score.
时间窗: Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended(up to 6 weeks)
Assessment of patient reported pain using a 1-10 score is collected on a diary card that subjects fill out once daily.
Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria
时间窗: Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended (up to 6 weeks)
Grading of PPE by NCI CTC criteria is collected on a diary card that subjects fill out once daily. Investigators assess and fill the grading into the case report form every week.
次要结局
- Instrumental Activities of Daily Living Scale(Baseline and after the intervention completed (up to 6 weeks))
- Dermatology Life Quality Index (DLQI) Total Score(Baseline and after the intervention completed (up to 6 weeks))
- Chemotherapy completion rate(After the intervention completed (up to 6 weeks))
- Incidence of cessation of capecitabine thereby(After the intervention completed (up to 6 weeks))
- Incidence of reduced dosage of capecitabine thereby(After the intervention completed (up to 6 weeks))
研究者
Yanni Lou
Attending Doctor
China-Japan Friendship Hospital