CTRI/2023/06/054536尚未招募3 期
A double-blind, randomized, placebo-controlled, parallel arm study evaluating the safety and efficacy of cannabinoid-containing formulations in cancer pain management along with improvement in quality of life of patients with metastatic breast cancer. - Nil
Pillcraft Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female patients aged between 18-70 years (both inclusive);
- •2.The patient diagnosed with metastatic breast cancer including but not limited to bone metastases of severity stage 4 underwent surgery, and/ or, receiving chemotherapy, radiation or immunotherapy;
- •3.The patient has a clinical diagnosis of cancer-related pain (NPRS scale score between 1-6 i.e., mild to moderate pain);
- •4.The patient receiving Step I or II pain medication according to the World Health Organization (WHO) analgesic ladder.
- •?First step - Mild pain: non-opioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen with or without adjuvants
- •?Second step - Moderate pain: weak opioids (hydrocodone, codeine, tramadol) with or without non-opioid analgesics, and with or without adjuvants
- •? Third step - Severe and persistent pain: potent opioids (morphine, methadone, fentanyl, oxycodone, buprenorphine, tapentadol, hydromorphone, oxymorphone) with or without non-opioid analgesics, and with or without adjuvants
- •5.The patient is able (in the investigators opinion) and willing to comply with all study requirements;
- •6.With or without comorbidity, if comorbid on stable prescription.
排除标准
- •The patients should not present any of the following exclusion criteria-
- •1.Patients eligible for hospice care that is when a patient has stopped responding to all possible treatments for their illness;
- •2.Using medical marijuana currently;
- •3.Have a known sensitivity to cannabinoids;
- •4.Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition;
- •5.Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non-prescribed use of any prescription drug;
- •6.The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure);
- •7.The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction;
- •8.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, antiretroviral;
- •9.Inability to take oral medications and/or painful erythema, oedema or ulcers under the tongue.
- •10.Uncontrolled diarrhea, nausea, vomiting, sub ileus or intestinal obstruction.
- •11.Systemic diseases like uncontrolled hypertension, uncontrolled diabetes, heart diseases, and lung diseases as per investigator’s discretion;
- •12.Subjects with the presence or suspected to have metastatic changes in the liver at the time of screening;
- •13.Patients having deranged biochemical parameters from blood samples at screening:
- •AST (SGOT), ALT (SGPT) greater than 1.5 x ULN if no evidence of liver metastases;
- •Total bilirubin greater than1.5 mg/dL;
- •Creatinine greater than 2 mg/dL;
- •Alkaline phosphatase greater than 5 x ULN.
- •14.Patients having the deranged hematology levels at screening like:
- •Platelets less than 100 x 109 cells/L;
- •Hemoglobin less than 9 gm/dL.
- •15.Pregnancy and breastfeeding women;
- •16.Any other illness or abnormal laboratory investigations which the investigator considers as making the patient ineligible for the study.
研究者
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