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

Not Applicable

• Conditions: metastatic or recurrent cancer at stage III or IV; Cancer - Any cancer

• Registration Number: ACTRN12622001288718
• Lead Sponsor: Sydney Local Health District, Concord Repatriation General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-04
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The side effects of Annona muricata consumption in human were found to be mild, including nausea (13%), heart burn (epigastric pain) (6.6%). In an observational study in human, movement disorders had also been reported. <br>Safety and tolerability assessed by self-reporting of adverse effects using the participant dosing diary, full clinical assessment including clinical consultation and standard neurological assessment. Standardised mini-mental state examination will be conducted by clinical trial doctor during consultation.<br>Carcinoembryonic antigen, liver and renal function test and blood glucose will be assessed by whole blood samples. Blood pressure will be assessed by sphygmomanometer.[ Experience of adverse effect will be monitored and recorded daily in participant dosing diary until week 12 post-intervention commencement. Full clinical assessment will be conducted at baseline, week 3, 6, 9 and 12 post-intervention commencement.]