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

Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Annona muricata extract; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Annona muricata extract; Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks	Dietary supplement: Annona muricata extract; ethanol-soluble fraction of water extract
Placebo Comparator: Placebo; Maltose capsule, 300 mg/day, for eight weeks	Dietary supplement: Placebo; maltose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nutritional Status	eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytotoxicity	Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay	two days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Lili Indrawati, MSc, Indonesia University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Patients; After Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 406/H2.F1/ETIK/2013