NCT04773769

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

Pilot Phase 2 Study of Graviola (Guanabana) Leaves for The Treatment of Patients With Relapsed or Refractory Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphomas and Colorectal Adenocarcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Auxilio Mutuo Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastric Adenocarcinoma
• Adenocarcinoma of the Gastroesophageal Junction
• Hepatocellular Carcinoma
• Pancreatic Adenocarcinoma
• Low Grade Lymphoma
• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tea Made of Graviola Leaves	Graviola leaves will be supplied to the patient with instructions on how to prepare the tea which will consist of 10 guanabana leaves which the patient will boil in 1 liter of water for 3 minutes. Once boiled, the formulation will be stores in the refrigerator and once cool enough the patient will start drinking 100 cc two times per day. The Treatment Period begins with Cycle 1 Day 1 dosing. Patients will take the tea continuously during a 28-day cycles, until there is an indication for treatment change based on response assessment.

Timeline

• Start date: 2018-11-07
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-02-26
• Last updated: 2021-02-26

Locations

1 site across 1 country: Puerto Rico