Mistletoe Therapy in Primary & Recurrent Inoperable Pancreatic Cancer. A Phase III Prospective Randomized Double Blinded Multicenter Parallel Group Placebo Controlled Clinical Trial on Overall Survival and Quality of Life
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in inoperable pancreatic cancer in order to evaluate effect on overall survival and health-related quality of life. Half of participants will take subcutaneous injections with mistletoe in addition to standard therapy (palliative chemotherapy or best supportive care); the other half will receive a placebo and standard therapy.
详细描述
Extracts from European mistletoe (Viscum album L.) have been used as complementary cancer therapy since the 1920s. To date over 160 clinical studies on mistletoe in cancer therapy have been conducted with varying quality; the therapy is still controversial.
Best evidence is found for increase of health-related quality of life (HRQoL) and reduction of side effects of conventional therapies (chemotherapy, radiation) in breast cancer patients. Mistletoe treatment is described as safe and well tolerated. There are some clinical studies supporting the use of mistletoe extract in the management of late stage cancer.
Statistically significant effects on overall survival (OS) and HRQoL in pancreatic cancer patients have recently been shown in a randomized open label trial in Serbia investigating the addition of mistletoe extract to best supportive care. The results are questioned because patients knew what kind of treatment they received.
Mistletoe extracts are usually administered subcutaneously. They contain a multitude of substances with immune modulatory and cytotoxic or - in animal studies - antitumorigenic, anti-metastatic and antiangiogenic effects.
This trial investigates whether there is a beneficial effect of mistletoe extracts on OS and HRQoL in pancreatic cancer patients receiving standard treatment (palliative chemotherapy or best supportive care).
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
- Triple (Participant, Care Provider, 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
- •Signed written informed consent
- •Age ≥ 18 years
- •Inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.
- •Primary diagnosis: if histology is not clinically achievable diagnosis is to be confirmed according to local practice sufficient for diagnosis and choice of therapy (such as CA19-9 (=cancer antigen 19-9) and CT).
- •Relapse: histology (not required) or diagnosis according to local practice such as clinical signs and/or imaging and/or CA19-
- •ECOG ( Eastern Cooperative Oncology Group) performance status 0-2 (see table in section 12.14 )
- •Adequate negative pregnancy test and adequate contraception (where appropriate)
排除标准
- •Life expectancy less than 4 weeks
- •Pregnancy or breastfeeding
- •Neuroendocrine tumors of the pancreas (NET)
- •Current use of interferon, G-CSF (granulocyte colony-stimulating factor) and thymus preparations
- •Symptomatic brain edema due to brain metastases
- •Known hypersensitivity to mistletoe-containing products
- •Current use of mistletoe extract preparations in any form
- •Chronic granulomatous disease or active autoimmune disease or autoimmune disease with immunosuppressive treatment
- •Medical, psychiatric, cognitive or other conditions that may compromise the patient´s ability to understand the patient information, give informed consent, comply with the study protocol or complete the study (e.g. needle phobia).
研究组 & 干预措施
Mistletoe extract (Iscador Qu)
Fermented aqueous extract of Viscum album ssp album (L.) (mistletoe) = Iscador Qu, subcutaneous use 3 injections/week; dose escalation from 0,01mg - 20mg
干预措施: Mistletoe extract (Iscador Qu) (Drug)
Placebo
isotonic saline solution, subcutaneous use 3 injections/week
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: End of study (estimated 3 years)
OS defined as time from randomization to death for any reason
次要结局
- Incidence of treatment-emergent adverse events (AE)(Through study completion (9 months))
- Quality of Life questionnaire EORTC PAN -26(At 7 visits during study (9 months))
- Chemotherapy use (number of cycles first line, second line, ..) and dose reduction in%(At 7 visits during study (9 months))
- Quality of Life questionnaire EORTC QLQ-C30(At 7 visits during study (9 months))
- Use of oral nutrition support per week (number used per day)(At 7 visits during study (9 months))
- Number of visits of homecare team per week(At 7 visits during study (9 months))
- Days of unplanned inpatient care(At 7 visits during study (9 months))
- Weight in kilograms, height in meters, BMI in kg/m^2(At 7 visits during study (9 months))
- Corticosteroid use in milligrams betamethasone per day and indication (appetite, chemotherapy, nausea, pain, general wellbeing, other: specified)(At 7 visits during study (9 months))
- Use of symptom relieving medication in mg/day (painkillers, antiemetic and anxiolitic medication)(At 7 visits during study (9 months))
- Number of parenteral nutrition infusions per week(At 7 visits during study (9 months))
研究者
Kathrin Wode
MD
Karolinska University Hospital