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Open Access 01-12-2023 | Gastrointestinal Cancer | Study Protocol

Exploring the safety and efficacy of phytomedicine Petiveria alliacea extract (Esperanza) in patients with metastatic gastrointestinal tumors and acute leukemias: study protocol for a phase Ib/randomized double blind phase II trial (PA001)

Authors: Ricardo Ballesteros-Ramírez, Paola Pinilla, Jesús Sanchéz, Mónica Arévalo, Elio Sanchez, Pablo Aschner, Claudia Urueña, Susana Fiorentino

Published in: BMC Complementary Medicine and Therapies | Issue 1/2023

Abstract

Background

The energy metabolism of drug-resistant tumor cells can provide a survival advantage during therapy, and treatment itself may influence metabolic reprogramming. Petiveria alliacea (Traditional name: Anamu) could inhibit glycolysis and OXPHOX modulating tumor metabolism, making it a potential treatment for tumors with altered metabolism. This clinical study aims to evaluate the safety and efficacy of a standardized Anamu phytomedicine called Esperanza in treating gastric tumors and acute leukemias.

Methods

This is a prospective, open label, phase I/ randomized, double-blind single-center phase II study designed to evaluate the safety and efficacy of Esperanza extract in patients with metastatic gastrointestinal tumors and acute leukemias. In stage 1, the study will determine the MTD and assess safety. In stage 2, safety at the MTD will be evaluated, and the efficacy of Esperanza extract will be explored in both metastatic gastric tumors and acute leukemias. Quality of life improvement will be the primary outcome in the gastric tumor group, while different efficacy outcomes will be assessed in the acute leukemia group. A placebo group will be used for comparison in the gastric tumor group, and a historical control group will be used in the acute leukemia arm.

Discussion

This clinical trial aims to evaluate the safety profile of the Esperanza extract in patients with metastatic gastrointestinal tumors and acute leukemias, while exploring its potential efficacy in conjunction with standard treatment for these pathologies.

Trial registration

This trial was registered in the US National Library of Medicine with identifier NCT05587088. Registered October 19^th, 2022.

Available only for authorised users

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Title: Exploring the safety and efficacy of phytomedicine Petiveria alliacea extract (Esperanza) in patients with metastatic gastrointestinal tumors and acute leukemias: study protocol for a phase Ib/randomized double blind phase II trial (PA001)
Authors: Ricardo Ballesteros-Ramírez
Paola Pinilla
Jesús Sanchéz
Mónica Arévalo
Elio Sanchez
Pablo Aschner
Claudia Urueña
Susana Fiorentino
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Gastrointestinal Cancer
Published in: BMC Complementary Medicine and Therapies / Issue 1/2023
Electronic ISSN: 2662-7671
DOI: https://doi.org/10.1186/s12906-023-04109-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Exploring the safety and efficacy of phytomedicine Petiveria alliacea extract (Esperanza) in patients with metastatic gastrointestinal tumors and acute leukemias: study protocol for a phase Ib/randomized double blind phase II trial (PA001)

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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