Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 8
- 主要终点
- Demonstrate a 50% decrease of the grade> or = 2 neurotoxicity at 4 months after oxaliplatin-based chemotherapy start in the PHYCOCARE arm
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%. Clinically, CIPN is a mostly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration.
Due to its high prevalence among cancer patients, CIPN constitutes a major problem for both cancer patients and survivors as well as for their health care providers, especially because, at the moment, there is no single effective method of preventing CIPN; moreover, the possibilities of treating this syndrome are very limited.
The phycocyanin (PC), a biliprotein pigment and an important constituent of the blue-green alga Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress.
Study hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastro intestinal cancers including oesogastric, colo-rectal and pancreatic cancers. This trial will be a randomised placebo-controlled study.
详细描述
The phycocyanin used in this protocol (Phycocare®) will be 5 times more concentrated than the Spirulysat (food supplement commercialized by Algosource).
It will be administrated during Oxaliplatin based chemotherapy and 3 months after oxaliplatin stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
The placebo will match as much as possible all the characteristics of the Phycocare®
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
- •Male or female with the age > or = to 18 years old.
- •Negative pregnancy test for women with child-bearing potential if applicable (without hysterectomy for example)
- •Information given to the patient who must have signed informed consent
- •Patient with Histologically or cytologically proven gastro intestinal cancer including oesogastric, colo-rectal, pancreatic cancers, locally advanced pancreatic cancers and planned to be treated with oxaliplatin
- •Patient with metastatic disease not previously treated
- •Patient willing not to take any plant-based therapy during the study (including phytotherapy and gemmotherapy)
- •Previous radiotherapy is authorized if discontinued ≥15 days prior to randomization
- •Sites of disease evaluated within 42 days prior C1 day 1 of chemotherapy with thoracic-abdominal-pelvic CT scan (or abdominal-pelvic MRI and chest X-ray)
- •Patient with ECOG Performance status 0 or 1
- •Patients with a Life expectancy ≥12 weeks
- •Laboratory results:
- •Hematologic function:
- •polynuclear neutrophils ≥ 1.5.109/L platelets ≥100.109/L haemoglobin ≥9 g/dL
- •Hepatic function:
- •transaminases ≤2.5 times upper limit of normal (ULN) (≤5 ULN in case of hepatic metastases), alkaline phosphatases ≤2.5 x ULN (≤5 ULN in case of hepatic metastases), total bilirubin ≤1.5 x ULN
- •Renal function:
- •creatinemia clearance >50 ml/min (Cockcroft and Gault)
- •- Patient with Public Health insurance coverage
排除标准
- •Patients with phenylketonuria
- •Patients with known meningeal or brain metastases
- •Patient previously treated for their metastatic cancer
- •Patient previously treated with oxaliplatin
- •Patient with specific contraindication or known hypersensitivity to spirulina
- •Patient with specific contraindication or known hypersensitivity to oxaliplatin.
- •Known allergy or hypersensitivity to antibodies or any preservatives if patient is treated with a monoclonal antibody combined to chemotherapy (bevacizumab or cetuximab or panitumumab or nivolumab or Trastuzumab For patients treated with trastuzumab : patient without HER2 overexpression (defined by positive IHC3 or positive IHC2 and confirmed by a positive FISH result)
- •Patient with clinically significant coronaries affection or myocardial infarction within 6 months prior to randomization.
- •Patient with peripheral neuropathy >1 (CTCAE scale version 5.0).
- •Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Patient with acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine or presence of a colic prosthesis.
- •Patient with unhealed wound, active oesogastric or duodenal ulcer, or bone fracture
- •Patient with an history of abdominal fistulas, trachea-esophageal fistulas or any other grade 4, gastro-intestinal perforations or non-gastrointestinal fistulas or intra-abdominal abscesses during the 6 months before randomization.
- •For patient treated with bevacizumab: patient with uncontrolled arterial hypertension (systolic pressure >150 mmHg and/or diastolic pressure >100 mmHg) with and without antihypertensive medication. Patients with high hypertension are eligible if antihypertensive medication lowers their arterial pressure to the level specified by the criterion.
- •Patient with an history of hypertensive crisis or hypertensive encephalopathy
- •Patient with other concomitant malignancy or history of cancer (except in situ carcinoma of the cervix, or non-melanoma skin cancer, treated with curative intent treatment) except if considered in complete remission for at least 2 years before randomization
- •Existence of any other pathology, metabolic problem, anomaly during the clinical examination or biological anomaly which may reasonable suspect an underlying pathology which would contra- indicate the use of the study medication or any other risk of complication related to the treatment.
- •Any treatment including an experimental drug, or participation in another clinical trial within 28 days before randomization.
- •Pregnant women, or women who could possibly be pregnant (or who expect to fall pregnant within 6 months of the end of treatment), or who are breast feeding are not eligible.
- •Men and women of child-bearing potential who do not accept to use a highly effective contraceptive (as per currently acceptable institutional standards) or abstinence during the study and for the month after the last administration of the study treatments.
- •Persons deprived of liberty or under guardianship.
- •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究组 & 干预措施
Phycocare
PHYCOCARE during 12 cycles of 14 days from day -3 before oxaliplatin based chemotherapy until cycle 3 months after the last dose of oxaliplatin (18 cycles, about 9 months) From D-3 to D14 before cycle 1 chemotherapy: patient will take Phycocare From D1 to D14 of cycle 2 chemotherapy and further chemotherapy cycles : patient will take Phycocare On days of chemotherapy the patient does not take Phycocare
干预措施: Phycocare (Other)
Placebo
Placebo during 12 cycles of 13 days from day -3 before cycle 1 of oxaliplatin based chemotherapy until 3 months after the last dose of oxaliplatin (9 months).
From D-3 to D13 before cycle 1 chemotherapy: patient will take Placebo From D1 to D13 of cycle 2 chemotherapy and further chemotherapy cycles : patient will take Placebo.
On days of chemotherapy the patient does not take Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Demonstrate a 50% decrease of the grade> or = 2 neurotoxicity at 4 months after oxaliplatin-based chemotherapy start in the PHYCOCARE arm
时间窗: 4 months after oxaliplatin-based chemotherapy start
neurotoxicity according to NCI (National Cancer Institute) criteria in both arms
次要结局
- Comparison between the two arms of Neurological toxicities(end of study visit (an average of 9 months after cycle 1 day1))
- Comparison between the two arms of percentage of patients who stopped oxaliplatin for neurological toxicity(last day of chemotherapy)
- Comparison between the two arms of percentage of patients with oxaliplatin dose decrease(last day of chemotherapy)
- Comparison between the two arms of Neurological toxicities according to the Common Terminology Criteria for adverse Event (CTCAE) v5.0(end of study visit (an average of 9 months after cycle 1 day1))
- Comparison between the two arms of Overall Toxicity (including hematological toxicity, gastro-intestinal toxicity, etc…)(end of study visit (an average of 9 months after cycle 1 day1))
- Comparison between the two arms of Patient 's Quality of Life according with EORTC-QLQ-C30(end of study visit (an average of 9 months after cycle 1 day1))