Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer

Genital Neoplasms, Female Clinical Trial

Official title:

Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer and Its Association With Quality of Life and Sexual Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360459
• Other study ID #: Microbiota_ radiotherapy
• Status: Recruiting
• Start date: May 20, 2022
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Universidad Autonoma de Madrid
• Contact: María Bailen Andrino, PhD
• Phone: 0034629606088
• Email: mariabailen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study proposes the characterization of the intestinal and vaginal microbiota in long-term radiated cervical and endometrial cancer survivors to study the association with long-term radiotherapy side effects.

Description:

The human epithelial surface is colonized by a community of microorganisms, the microbiota, which disruption (dysbiosis) can impact a variety of functions, leading to inflammation, altered immunity and numerous diseases, including cancer. Pelvic cancers are among the most frequently diagnosed cancers worldwide, and pelvic radiotherapy is often an essential part of multimodal therapeutic approaches but can lead to a wide range of complications for which there is currently no treatment. The gut microbiota is altered by radiotherapy, and a relationship between gut microbiota composition, health status, and pelvic radiotherapy has been suggested. In recent years, there has been growing evidence that radiotherapy also alters the vaginal microbiota. The study proposes the characterization of the intestinal and vaginal microbiota in long-term radiated cervical and endometrial cancer survivors to study its association with long-term radiotherapy side effects. For this purpose, a descriptive cross-sectional study will be carried out in patients affected by cervical or endometrial cancer, in early stages, with good vital prognosis who have received radiotherapy, using healthy postmenopausal women as a control group. If the microbiota is indeed associated with the side effects of radiotherapy, this would open the possibility of identifying predictive markers, using machine learning analysis of the patients' quality of life, and would help in the search for future therapies based on the restoration of the vaginal and intestinal microbiota. Through network analysis, it would be possible to find out which factors related to patients' diet and lifestyle could be related to dysbiosis and radiotherapy-induced adverse outcomes and poor quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary diagnosis of cervical cancer or endometrial cancer.
• who have received external radiotherapy (with or without brachytherapy, with or without concomitant chemotherapy) more than 24 months ago.
• with clinical control in the last year that evidences that they are free of disease.
• who understand Spanish and have sufficient reading level to understand the questions of the quality of life questionnaires.
• sign and date the informed consent.

Exclusion Criteria:

• Recurrent or metastatic disease.
• Treatment with antibiotics or corticosteroids (3 months prior to taking the sample).
• Extreme diets (vegetarian, vegan).
• Pregnancy or lactation.
• Documented gastrointestinal diseases (gastric or duodenal ulcers, irritable colon, ulcerative colitis, Crohn's disease).
• Alcoholism (Defined as risk consumption (20-40 gr/day in women; which would be equivalent to 2-4 gr/day)
• Oral or vaginal hormone replacement therapy.
• Spermicidal products in the last 48 hours.
• Sexual intercourse in the last 48 hours.
• Immunocompromised patients. Control patients: healthy postmenopausal women with last menstrual period more than 12 months ago in those over 40 years of age.

Exclusion criteria (controls):

• Previous diagnosis of gynecologic or breast cancer.
• Current postmenopausal genital bleeding.
• Current vulvovaginal leucorrhea.

Related Conditions & MeSH terms

• Genital Neoplasms, Female

Intervention

Radiation:
• Exposure to radiotherapy
Characterization and quantification of intestinal and vaginal microbiota in patients affected by cervical or endometrial cancer who have received pelvic radiotherapy more than 24 months ago.

Locations

Country	Name	City	State
Spain	Hospital de Getafe	Getafe	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Maria Bailen Andrino	Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microbiota (fungal and bacterial)	Abundance of bacterial taxa determined by 16SRNAr gene sequencing and abundance of fungal taxa by ITS2 gene sequencing. Bacterial species will also be determined by qPCR	Baseline
Primary	Vaginal microbiota (fungal and bacterial)	Abundance of bacterial taxa determined by 16SRNAr gene sequencing and abundance of fungal taxa by ITS2 gene sequencing. Bacterial species will also be determined by qPCR	Baseline
Secondary	Quality of life of participants	Quality of life of participants with gynecological cancer determined by questionnaires: EORTC QLQ-30, EORTC QLQ-EN24 and EORTC QLQ-CX24 (European Platform of Cancer Research Quality of Life Cancer Patients questionnaire) and for healthy participants determined by MENQOL questionaire	Baseline