Revisions for Evaluation of the safety and the therapeutic effect of the Guanabana infusion in patients with breast cancer | Registro Público Cubano de Ensayos Clínicos

1 December 2024 - 10:43am by SSA	1 December 2024 - 10:43am by SSA

Changes to Recruitment status
-	Pending	+	Recruiting

Revision of 1 December 2024 - 10:43am:

Evaluation of the safety and the therapeutic effect of the Guanabana infusion in patients with breast cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

GPCM

Scientific title:

Evaluation of the safety and therapeutic effect of ingestion of the herbal remedy infusion (Tea) of soursop leaves (Annona muricata) in patients with breast cancer

Acronym of Scientific Title:

GPCM

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

National Council of Humanities, Sciences and Technologies (Conahcyt), Mexico.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ivan

Last name:

Delgado Enciso

Medical Specialty :

Molecular Biology

Affiliation:

State Institute of Cancerology of IMSS-BIENESTAR Colima, Mexico

Postal address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email address:

ivan_delgado_enciso@ucol.mx

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not Applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

11/11/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Breast cancer

Intervention(s):

Experimental Group (Group A): Will receive the standard treatment for their stage and clinical characteristics of cancer, indicated by their treating physicians, without the researchers intervening in this prescription. Additionally, they will receive individual filter paper envelopes, and each envelope will contain 10 grams of dried soursop leaves (Annona muricata) and 1 gram of dried Stevia rebaudiana leaf (as a sweetener), with which they will make a traditional preparation (remedy) by placing one envelope in 1 liter of boiling water, letting it rest for 15 minutes, of which they will take orally 3 cups a day (750 ml per day), from Monday to Friday (5 days per week), for 6 months. This infusion will be prepared daily and kept refrigerated during the day. Control Group (Group B): Will receive the standard treatment for their stage and clinical characteristics of cancer, indicated by their treating physicians, without the researchers intervening in this prescription. Additionally, they will receive individual envelopes of filter paper, and each envelope will contain 1g of dried Stevia rebaudiana leaf (as a sweetener, and as placebo), with which they will make a traditional preparation by placing one envelope in 1 liter of boiling water, letting it sit for 15 minutes, of which they will take orally 3 cups a day (750ml per day), from Monday to Friday (5 days per week), for 6 months. This infusion will be prepared daily and will be kept refrigerated during the day.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Complete response (Percentage of patients who achieve a Complete Response, defined as the disappearance of clinical and radiological evidence of the disease according to RECIST 1.1 criteria). Measurement time: 6 months.

Key secondary outcomes:

1. Adverse events (According to the Common terminology criteria for adverse events (CTCAE) version 5). Measurement time: every week until month 6. 2. Quality of life (Questionnaires EORTC QLQ-C30 and EORTC QLQ-BR23). Measurement time: At baseline and, at 6 months of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

85 years

Inclusion criteria:

1. Clinical and histological diagnosis of stage III-IV breast cancer (according to the American Society of Clinical Oncology, ASCO) classification. 2. Recently diagnosed breast cancer (within 6 months) and without previous treatment, or in disease recurrence after having been only in follow-up and without treatment (without chemo/radiotherapy) for at least one year. 3. Histology of adenocarcinoma, with any positivity to estrogen, progestin or her2neu receptors. 4. ECOG 0-2. 5. Platelets ≥ 100,000mm3. 6. Total serum bilirubin ≤1.5mg/dl.

Exclusion criteria:

1. Diagnosis of a primary cancer other than breast cancer. 2. Alcoholism and/or drug addiction. 3. Allergy to soursop. 4. Gastrointestinal ulcer. 5. Inflammatory bowel disease. 6. Diagnosis of ischemic heart disease. 7. Liver disease. 8. Kidney disease.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1-2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivan

Last Name:

Delgado Enciso

Specialty:

Molecular biology

Affiliation:

State Institute of Cancerology of IMSS-BIENESTAR Colima, Mexico

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email :

ivan_delgado_enciso@ucol.mx

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gustavo

Middle Name:

Alejandro

Last Name:

Hernandez Fuentes

Specialty:

Biomedical Chemistry

Affiliation:

Faculty of Medicine of the University of Colima, Mexico.

Postal Address:

Avenue Universidad 333, Colonia las viboras

City:

Colima

Country:

Mexico

Zip Code:

58040

Telephone:

+52-3123161099

Email :

gahfuentes@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Regional University Hospital of Health Services of the State of Colima (CONBIOETICA-06-CEI-001-20181109)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/05/2024

Postal address of Ethic Committee :

Kilometro 2, Carr. Colima-Guadalajara,Colonia El Porvenir, 28019,Colima, Colima. Mexico

Telephone:

+52-3123161902

Email:

ceihrucolima@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

27/09/2026

Date of available results:

27/10/2026

Date of first publication:

27/11/2026

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000451

Date of Registration in Primary Registry:

04/11/2024

Record Verification Date:

2024/12/01

Next update date:

2025/12/01

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Evaluation of the safety and the therapeutic effect of the Guanabana infusion in patients with breast cancer

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