Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of nausea/vomiting
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.
详细描述
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic Pancreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including nausea/vomiting, insomnia, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
Thalidomide is an oral medication used to treat a number of cancers (e.g. multiple myeloma), graft-versus-host disease, and many skin disorders (e.g. complications of leprosy such as skin lesions). It caused severe malformations in babies born to mothers taking the drug for morning sickness in the late 1950s and early 1960s. Thalidomide works on the immune system to reduce inflammation. Thalidomide may enhance the tolerability of chemotherapy by reducing nausea/vomiting, improving sleeping quality, alleviating pain, and thus improving quality of life for patients with pancreatic cancer.
The purpose of this study is to evaluate the efficacy of Thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Thalidomide) or the control group (gemcitabine combined with nab-paclitaxel). Rate of nausea/vomiting, index of sleep quality, severity of pain, quality of life, and overall survival are measured every four weeks.
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
- Double (Participant, Investigator)
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
- •Ability to understand and the willingness to sign a written informed consent document.
- •Age ≥ 18 years and ≤ 80 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
- •Adequate organ performance based on laboratory blood tests.
- •Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •The expected survival ≥ 3 months.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
排除标准
- •Patients who have received any form of anti-tumor therapy.
- •The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- •Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- •Pregnant or nursing women.
- •Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc).
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study.
- •Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
- •Patients who are unwilling or unable to comply with study procedures.
研究组 & 干预措施
Chemotherapy + Thalidomide
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
干预措施: Nab paclitaxel (Drug)
Chemotherapy + Thalidomide
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
干预措施: Thalidomide (Drug)
Chemotherapy + Thalidomide
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
干预措施: Gemcitabine (Drug)
Chemotherapy
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
placebo 100 mg/day, once a day, orally intake at night.
干预措施: Nab paclitaxel (Drug)
Chemotherapy
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
placebo 100 mg/day, once a day, orally intake at night.
干预措施: Gemcitabine (Drug)
Chemotherapy
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
placebo 100 mg/day, once a day, orally intake at night.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of nausea/vomiting
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.
次要结局
- Sleep quality index(At the end of Cycle 1 (each cycle is 28 days))
- Quality of life (QOL)(At the end of Cycle 1 (each cycle is 28 days))
- Overall survival (OS)(At the end of Cycle 1 (each cycle is 28 days))
- Pain numeric rating scale (NRS)(At the end of Cycle 1 (each cycle is 28 days))