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

May 12, 2015 updated by: Lili Indrawati, Indonesia University

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: eight weeks
eight weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Lili Indrawati, MSc, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 406/H2.F1/ETIK/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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