Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas

Last updated: February 24, 2021
Sponsor: Auxilio Mutuo Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Pancreatitis

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT04773769
CCAM 18-01
  • Ages > 18
  • All Genders

Study Summary

Guanabana, known also as Graviola or Annona muricata is a tropical fruit which has been commonly used as complimentary/alternative medicine in Latin American countries. The main compounds in Graviola are the annonaceous acetogenins. These acetogenins have been shown to be selective and toxic against various types of cancer cells in-vitro and in-vivo experimental animal models. In spite of this evidence of anti tumor activity of Graviola, no prospective clinical studies have been carried out to determine if it also has clinical activity.The Investigator have observed two patients at Auxilio Mutuo Cancer Center who experienced significant tumor shrinkage while taking a tea made of Graviola leaves. Neither of these patients were taking any other treatment for their cancer. The investigator propose to conduct a study using guanabana leaves extract in patients with Gastroesophageal junction(GEJ) adenocarcinoma, as well as in Gastric adenocarcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Low Grade Lymphomas and Colorectal adenocarcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age > 18 years at the time of signing the informed consent form.
  • Willing and able to adhere to the study visit schedule and other protocolrequirements.
  • Must have measurable or evaluable disease.
  • All previous cancer therapy, including radiation, hormonal therapy and surgery, musthave been discontinued at least 2 weeks prior to treatment in this study.
  • Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale atstudy entry.

Exclusion

Exclusion Criteria:

  • Patients actively taking guanabana or guanabana tea daily or who have used it at somepoint after their diagnosis of cancer.
  • Patients with Parkinson's disease.
  • Serum Total Bilirubin ≥ 3.0 mg/dL
  • Serum Creatinine level ≥ 3.0 mg/dL
  • Central Nervous System (CNS) involvement.
  • Known human immunodeficiency virus (HIV) infection; Known active hepatitis B orhepatitis C infection.
  • Females who are pregnant (positive urine test) or breast-feeding females.
  • Any history of a medical condition or a concomitant medical condition that, in theopinion of the investigator, would compromise the subject's ability to safely completethe study.

Study Design

Total Participants: 54
Study Start date:
November 07, 2018
Estimated Completion Date:
November 30, 2023

Study Description

Patients with relapsed/refractory gastric adenocarcinoma, adenocarcinoma of gastroesophageal junction, hepatocellular carcinoma, colorectal adenocarcinoma will be eligible. Colorectal adenocarcinomas will be eligible after failing second line therapy while the remainder will be eligible after first line therapy depending on the judgment of the treating oncologist. Any patient who refuse to receive chemotherapy will also be eligible even if they have not received chemotherapy. Patients with low grade lymphomas including chronic lymphocytic leukemias whose favorable blood counts and lack of symptoms make the candidates for "watch and wait" approach as well as any patient with low grade lymphoma who because of age or co-morbidity might not be eligible for chemotherapy or who refuse chemotherapy.

Connect with a study center

  • Auxilio Mutuo Cancer Center

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

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