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

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ClinicalTrials.gov Identifier: NCT02439580
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Lili Indrawati, Indonesia University

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Annona muricata extract Dietary Supplement: Placebo Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Nutritional Status [ Time Frame: eight weeks ]

Secondary Outcome Measures :
  1. Cytotoxicity [ Time Frame: two days ]
    Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439580


Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Lili Indrawati, MSc Indonesia University

Responsible Party: Lili Indrawati, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT02439580     History of Changes
Other Study ID Numbers: 406/H2.F1/ETIK/2013
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by Lili Indrawati, Indonesia University:
Patients
After Surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases