The safety and tolerability of Annona muricata leaf extract in people living with cancer

Sydney Local Health District, Concord Repatriation General Hospital0 个研究点目标入组 24 人开始时间: 2022年10月4日最近更新: 2022年10月10日

适应症

试验速览

暂无简介。

•Inclusion criteria include the diagnosis of metastatic or recurrent cancer at stage III or IV; willing and able to undertake the trial treatment and clinical follow-up; aged greater than or equal to 18 years of age; able to understand the English language in order to give consent and complete questionnaires. Patients who are clinically stable after CNS and/or cranial radiation will be included. This is supported by a lack of evidence of progression by CT scan or MRI or on clinical grounds.

•Exclusion criteria include participants who are actively undergoing (or intend to receive) chemotherapeutic and/or radiotherapeutic treatments; pregnant or breastfeeding; experience dysphagia; Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 3; life expectancy status less than or equal to 12 weeks; full blood counts with white blood cells < 3.0 × 109/L, absolute neutrophil count < 1.5 × 109/L, platelets < 100 × 109/dL; inadequate hepatic (either aspartate transaminase: ALT > 2.5 × upper limit of normal (ULN), or > 5 × ULN for liver metastatic patient or bilirubin > 1.5 × ULN) and/or renal function (< 50 mL/min/1.73 m2); mucositis (disrupted gastrointestinal integrity); grade 2 or higher peripheral neuropathy toxicity; diagnosis of any major psychiatric or neurodegenerative disorders such as Parkinson’s disease or dementia; other major serious medical illness such as poorly controlled diabetes or cardiovascular disease. Participants will also be excluded if they are concurrently taking other T&CM and unable to cease these medicines two weeks before the trial, already enrolled in other cancer treatment trials, plan to undergo major surgery during study, documented allergy to study treatment.

发起方

Sydney Local Health District, Concord Repatriation General Hospital