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

Last updated: May 12, 2015
Sponsor: Indonesia University
Overall Status: Completed

Phase

1

Condition

Colorectal Cancer

Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT02439580
406/H2.F1/ETIK/2013
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 30
Study Start date:
October 01, 2013
Estimated Completion Date:
October 31, 2014

Study 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.