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BMC Complementary Medicine and Therapies

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

Safety and efficacy of P2Et extract from Caesalpinia spinosa in breast cancer patients: study protocol for a randomized double blind phase II clinical trial (CS003-BC)

Authors: Ricardo Ballesteros-Ramírez, Paola Pinilla, Jesús Sanchéz, Lilian Torregrosa, Pablo Aschner, Claudia Urueña, Susana Fiorentino

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

Abstract

Background

Chemotherapy in breast cancer is effective but can generate significant toxicity and lead to tumor resistance. Joint treatment with standardized plant extracts can be an alternative to improve the response and allow an effective activation of the antitumor immune response that favors recovery in the short and long term. The P2Et extract of Caesalpinia spinosa presents antitumor activity in cells and animal models of breast cancer, improves the tumor microenvironment, and induces activation of the specific immune response against the tumor and is synergistic when used together with anthracyclines, which makes it a good candidate for evaluation in patients.

Methods

Conducted at a single center, this phase II study is a randomized, double-blind, placebo-controlled trial aimed at assessing the safety and efficacy of P2Et extract in patients diagnosed with stage II and III breast cancer, who are eligible for neoadjuvant treatment. The study aims to determine the safety profile at the previously established optimal biological dose from phase I trial while investigating various efficacy outcomes. These outcomes include improvements in quality of life, immunomodulation, metabolic profile, microbiome, as well as clinical indicators such as tumor reduction, disease-free survival, and pathological response, assessed at different stages of the treatment regimen.

Discussion

Treatment with the P2Et extract in breast cancer patients is hypothesized to enhance overall well-being, positively influencing their quality of life, while also triggering an antitumor immune response and enhancing immune infiltration. These combined effects have the potential to contribute to improved long-term survival outcomes for patients receiving the phytomedicine alongside neoadjuvant chemotherapy treatment.

Trial registration

This trial was registered in the US National Library of Medicine with identifier NCT05007444. First Registered August 16^th, 2021. Last Updated: August 9^th, 2022.

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Title: Safety and efficacy of P2Et extract from Caesalpinia spinosa in breast cancer patients: study protocol for a randomized double blind phase II clinical trial (CS003-BC)
Authors: Ricardo Ballesteros-Ramírez
Paola Pinilla
Jesús Sanchéz
Lilian Torregrosa
Pablo Aschner
Claudia Urueña
Susana Fiorentino
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Breast Cancer
Breast Cancer
Published in: BMC Complementary Medicine and Therapies / Issue 1/2023
Electronic ISSN: 2662-7671
DOI: https://doi.org/10.1186/s12906-023-04139-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Safety and efficacy of P2Et extract from Caesalpinia spinosa in breast cancer patients: study protocol for a randomized double blind phase II clinical trial (CS003-BC)

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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