Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells

Early Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Annona muricata extract; Dietary Supplement: Placebo

• Registration Number: NCT02439580
• Lead Sponsor: Indonesia University

Brief Summary

Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.

To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.

Detailed Description

Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-10
• Study First Submitted: 2015-04-27
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with Colorectal Carcinoma
• Have undergone standard therapy
• Satisfactory haematological or biochemical functions
• Karnofsky performance status of ≥ 60%
• Willing not to take probiotic supplement during study period

Exclusion Criteria

• Uncontrolled hypertension
• Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
• Physical and mental disability that renders them unable to verbally communicate
• History of recent cancers
• Pregnant, lactating, or not using adequate contraception
• Patient on other investigational drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Annona muricata extract	Annona muricata extract	Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks
Placebo	Placebo	Maltose capsule, 300 mg/day, for eight weeks

Primary Outcome Measures

Name	Time	Method
Nutritional Status	eight weeks

Secondary Outcome Measures

Name	Time	Method
Cytotoxicity	two days	Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay