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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date May 14, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
Nutritional Status [ Time Frame: eight weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
Cytotoxicity [ Time Frame: two days ]
Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
Cytotoxicity [ Time Frame: two days ]
Colorectal cancer cell lines were treated with serum from patients' serum
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
Official Title  ICMJE Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Dietary Supplement: Annona muricata extract
    ethanol-soluble fraction of water extract
  • Dietary Supplement: Placebo
    maltose
Study Arms  ICMJE
  • Experimental: Annona muricata extract
    Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks
    Intervention: Dietary Supplement: Annona muricata extract
  • Placebo Comparator: Placebo
    Maltose capsule, 300 mg/day, for eight weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2015)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439580
Other Study ID Numbers  ICMJE 406/H2.F1/ETIK/2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lili Indrawati, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lili Indrawati, MSc Indonesia University
PRS Account Indonesia University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP