Peri-operative cannabis use in patients undergoing pancreaticoduodenectomy for pancreatic and periampullary carcinoma- A phase II,III open label randomized controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- To evaluate Disease-free survival (DFS) with perioperative cannabis as compared to standard treatment in patients undergoing pancreaticoduodenectomy for pancreatic cancer and periampullary carcinoma
研究概览
简要总结
This is a randomized controlled study to assess the effect of cannabis administered at safe medical dose on survival in patients undergoing pancreaticoduodenectomy for pancreatic and periampullary carcinoma. We will be administering cannabis formulation (Cap THC or CBD, 7.5mg CBD and 7.5 mg THC per 100 mg) once a day starting from 4 days before surgery. A total of 5 pre-operative doses will be given with 5th dose being on the day of surgery. After that we will be administering Cap THC or CBD (2.5mg CBD and 2.5 mg THC per 100 mg )three times a day along with adjuvant chemotherapy from one day prior to start of chemotherapy and continued daily till 4 days after completion of the chemotherapy cycle during all cycles. This study is a open label randomized, controlled prospective phase II/III clinical trial.
Participants who are getting enrolled will be randomly distributed to either of the two groups. One group will get cannabis formulation as described along with standard treatment and other group will get standard treatment only. Before participating in the study patients will undergo psychiatric assessment to assess fitness to receive cannabis formulation. Patients have to read the consent document carefully in the language they best understand before giving consent to participate in the study. Primary end point of the study is to assess the disease free survival and overall survival. The adverse effects of cannabis formulations have been explained in detail in consent form.
The treatment is expected to improve overall outcome of the patient in terms of time till recurrence and overall survival. There is also a possibility that there may not be a direct benefit to the participants from this study. Advances in cancer treatment and discovery of effective drugs that are being used today are the result of clinical studies that have been done in the past.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Treatment naïve patients with radiologically suspected or histopathologically proven pancreatic cancer and periampullary carcinoma, undergoing curative intent treatment.
- •2.Age more than 18 and less 65 3.Valid informed consent 5.Non-metastatic 6.Undergoing curative surgery for operable pancreatic cancer and periampullary carcinoma(T1 to T3, N0 to N1, M0).
排除标准
- •Undergoing any other pre or peri-operative intervention such as neoadjuvant chemotherapy or radiotherapy
- •Presence of medical disease that may alter PKPD of cannabinoids such as pulmonary, renal, liver, gastro-intestinal disease which will interfere with any study specific procedure
- •Presence of uncontrolled cardiovascular disease, controlled hypertensives or diabetics will be allowed
- •History of substance abuse (including cannabis-related products) or alcohol abuse
- •Personal history of psychiatric disease
- •Significant family history of psychiatric disease
- •Pregnancy and or lactation.
- •Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
- •Patients on other medications which will likely have a drug interaction with cannabis- such as clozapine, duloxetine, naproxen, cyclobenzaprine, olanzapine, haloperidol, and chlorpromazine, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil (and other PDE5 inhibitors), antihistamines, haloperidol, antiretrovirals
- •Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study.
- •11.Any patient with positive HIV, HBsAg, HCV status.
结局指标
主要结局
To evaluate Disease-free survival (DFS) with perioperative cannabis as compared to standard treatment in patients undergoing pancreaticoduodenectomy for pancreatic cancer and periampullary carcinoma
时间窗: Disease free survival upto 3 years
次要结局
- 5 years Overall Survival(OS)(5 years from the date of randomisation)
- To evaluate the safety and tolerability of preoperative cannabis.(2 hours, 4 hours, 6 hours, 12 hours and 24 hours after study drug administration)
- To assess the pathological response to preoperative cannabis.(Immediately after surgery)
- To study the pharmacokinetics and pharmacodynamics of cannabis(Blood collection will be done once pre-dose 30 mins, 1 hour, 2 hours, 4 hours and 8 hours post-dose.)
研究者
Dr Manish Bhandare
TATA MEMORIAL HOSPITAL