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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02439580

Enrollment

Registered

2015-05-12

Start date

2013-10-31

Completion date

2014-10-31

Last updated

2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Patients, After Surgery

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.

Interventions

DIETARY_SUPPLEMENTAnnona muricata extract

ethanol-soluble fraction of water extract

DIETARY_SUPPLEMENTPlacebo

maltose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Nutritional Status	eight weeks

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026