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

U

University of Indonesia (UI)

Status and phase

Completed
Early Phase 1

Conditions

Colorectal Cancer

Treatments

Dietary Supplement: Annona muricata extract
Dietary Supplement: Placebo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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