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

NCT ID: NCT02439580

Last Updated: 2015-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Annona muricata extract

Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks

Group Type: EXPERIMENTAL

Annona muricata extract

Intervention Type: DIETARY_SUPPLEMENT

ethanol-soluble fraction of water extract

Placebo

Maltose capsule, 300 mg/day, for eight weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

maltose

Interventions

Annona muricata extract

ethanol-soluble fraction of water extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo

maltose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Lili Indrawati

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lili Indrawati, MSc

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Other Identifiers

406/H2.F1/ETIK/2013

Identifier Type: -

Identifier Source: org_study_id