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

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

Tracking Information

• First Submitted Date: April 27, 2015
• First Posted Date: May 12, 2015
• Last Update Posted Date: May 14, 2015
• Study Start Date: October 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 6, 2015): Nutritional Status [ Time Frame: eight weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Colorectal Cancer

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2015): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02439580
• Other Study ID Numbers: 406/H2.F1/ETIK/2013
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lili Indrawati, Indonesia University
• Study Sponsor: Indonesia University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lili Indrawati, MSc; Indonesia University

• PRS Account: Indonesia University
• Verification Date: May 2015