Evidence map›Paper›PMID 37563608›Full record

ArticleBMC complementary medicine and therapies2023

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).

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05587088 (Evaluation of the Safety and Efficacy of Esperanza Extract), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05587088 phase1 / phase2unknown statusnot on this map

Evaluation of the Safety and Efficacy of Esperanza Extract (Petiveria Alliacea) in Patients With Metastatic Gastrointestinal Tumors and Acute Leukemia

TypeinterventionalSponsorHospital Universitario San IgnacioRan2022 to 2023Enrolled82ConditionsNeoplasm, Stomach, Gastric Neoplasms Malignant, Pancreatic Neoplasms, Colorectal NeoplasmsArmsPetiveria Alliacea Preparation, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Ricardo Ballesteros-RamírezGrupo de Inmunobiología Y Biología Celular, Facultad de Ciencias, Pontificia Universidad Javeriana, Carrera 7 No. 43-82, Edificio Félix Restrepo, Lab 101. , C.P.110211, Bogotá, Colombia.
Paola PinillaCentro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia.
Jesús SanchézCentro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia.
Mónica ArévaloCentro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia.
Elio SanchezCentro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia.
Pablo AschnerOficina de Investigaciones, Hospital Universitario San Ignacio, Bogotá, Colombia.
Claudia UrueñaGrupo de Inmunobiología Y Biología Celular, Facultad de Ciencias, Pontificia Universidad Javeriana, Carrera 7 No. 43-82, Edificio Félix Restrepo, Lab 101. , C.P.110211, Bogotá, Colombia.
Susana FiorentinoGrupo de Inmunobiología Y Biología Celular, Facultad de Ciencias, Pontificia Universidad Javeriana, Carrera 7 No. 43-82, Edificio Félix Restrepo, Lab 101. , C.P.110211, Bogotá, Colombia. susana.fiorentino@javeriana.edu.co.
Hospital Universitario San Ignacio · COPontificia Universidad Javeriana · CO

Funding

Ministerio de Ciencia Tecnología e Innovación, Minciencias FP44842-221-2018
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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 registrationThis trial was registered in the US National Library of Medicine with identifier NCT05587088. Registered October 19

Indexed as

LeukemiaPhytolaccaceaeStomach NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicHumansProspective StudiesQuality of LifeRandomized Controlled Trials as TopicUnited StatesEfficacyHerbal DrugsPetiveria alliaceaQuality of LifeSafetyTumoral metabolism

Identifiers

PMID37563608
PMCPMC10413616
OpenAlexW4385740121

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.