Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT04773769
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas
Sponsor:
Auxilio Mutuo Cancer Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: