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

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Annona muricata extract
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Annona muricata extract<br>Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks | Dietary Supplement: Annona muricata extract<br>* ethanol-soluble fraction of water extract<br>|
| Placebo Comparator: Placebo<br>Maltose capsule, 300 mg/day, for eight weeks | Dietary Supplement: Placebo<br>* maltose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Status |  | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytotoxicity | Cytotoxicity against colorectal cancer cell lines that were treated with serum of participants, is assessed by MTT assay | two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients, After Surgery