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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439580
• Other study ID #: 406/H2.F1/ETIK/2013
• Status: Completed
• Phase: Phase 0
• First received: April 27, 2015
• Last updated: May 12, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Annona muricata extract
ethanol-soluble fraction of water extract
• Placebo
maltose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional Status		eight weeks	Yes
Secondary	Cytotoxicity	Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay	two days	No