Back to resultsEffect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Annona muricata extract
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Patients, After Surgery
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Annona muricata extract
Placebo
Arm Description
Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks
Maltose capsule, 300 mg/day, for eight weeks
Outcomes
Primary Outcome Measures
Nutritional Status
Secondary Outcome Measures
Cytotoxicity
Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02439580
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Patients, After Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Annona muricata extract
Arm Type
Experimental
Arm Description
Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltose capsule, 300 mg/day, for eight weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Annona muricata extract
Intervention Description
ethanol-soluble fraction of water extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
maltose
Primary Outcome Measure Information:
Title
Nutritional Status
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Cytotoxicity
Description
Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay
Time Frame
two days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lili Indrawati, MSc
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
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