None listed
Conditions
Brief summary
This study aims to determine whether the use of a herbal treatment (Annona muricata leaf product) is safe and tolerable for use in people with stage III and IV cancers of any type, who are not undergoing chemotherapy treatment. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any cancer type that is at stage III or stage IV, and you are not currently undergoing chemotherapy. Study details Participants who choose to enrol in this phase I study will be allocated to one of two doses of Annona muricata leaf product, and will be asked to take either one or two capsules daily for 12 weeks. At the time of enrolment, 3, 6, 9 and 12 weeks after their first dose, participants will be asked to provide a blood sample and to complete a series of questionnaires. It is anticipated that these tasks will take up to 30 minutes to complete, participants will be able to complete the questionnaire from home if they prefer. It is hoped this research will inform the clinical management and guidance provided by clinicians involved in the care of people who choose to use Annona muricata leaf product in the overall management of their cancer. If this product is found to be safe and tolerable, it may be prescribed to future cancer patients as an additional treatment.
Interventions
The interventional treatment is an oral capsule containing Annona muricata leaf powder.
Participants (n = 24) will be allocated to one of two groups for 12 weeks. The first 12 participants recruited will receive 530 mg Annona muricata capsule once daily, while the next 12 participants recruited will receive 530 mg Annona muricata capsule twice daily.
Adherence of Annona muricata capsules will be assessed by participant dosing diary and by counting returned medication as compared to the prescribe
The interventional treatment is an oral capsule containing Annona muricata leaf powder. Participants (n = 24) will be allocated to one of two groups for 12 weeks. The first 12 participants recruited will receive 530 mg Annona muricata capsule once daily, while the next 12 participants recruited will receive 530 mg Annona muricata capsule twice daily. Adherence of Annona muricata capsules will be assessed by participant dosing diary and by counting returned medication as compared to the prescribed dose at week 6 and week 12.
Sponsors
Sydney Local Health District, Concord Repatriation General Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed