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

University of Indonesia (UI)

Status and phase: Completed; Early Phase 1

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Annona muricata extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02439580

406/H2.F1/ETIK/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Annona muricata extract

Experimental group

Description:

Annona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks

Treatment:

Dietary Supplement: Annona muricata extract

Placebo

Placebo Comparator group

Description:

Maltose capsule, 300 mg/day, for eight weeks

Treatment:

Dietary Supplement: Placebo