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Completed

NCT Number: NCT02439580

Effect of Annona Muricata Leaves on Colorectal Cancer Patients 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Annona muricata extract

Dietary Supplement

ethanol-soluble fraction of water extract

Placebo

Dietary Supplement

maltose

Primary outcomes

  1. Nutritional Status

    Time frame: eight weeks

Secondary outcomes

  1. Cytotoxicity

    Time frame: two days

    Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 12, 2015
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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