Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy

NCT05736315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-02-21

No results posted yet for this study

Summary

Many cancer survivors have increased risk of intestinal damage, affecting the quality of life of patients. The role of intestinal microbiota on the development of gastrointestinal toxicity and radiation enteritis has been described in cervical cancer patients that received pelvic RT. In this project we investigated the effect that a fermented dairy beverage (Yakult) may have in the modulation of inflammation and consequently of gastrointestinal toxicity in locally advanced cervical cancer (LACC) patients treated with concomitant chemo-radiotherapy (CRT).

Conditions

  • Cervical Cancer, Stage IIB

Interventions

OTHER

Placebo dairy beverage

Placebo dairy beverage (placebo) is a sweetened dairy beverage.

Sponsors & Collaborators

  • Yakult Honsha Co., LTD

    collaborator INDUSTRY
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    collaborator OTHER
  • Instituto Nacional de Perinatologia

    collaborator OTHER_GOV
  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Lucely Cetina Pérez, MD, PhD · Instituto Nacional de Cancerologia de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-25
Primary Completion
2007-06-25
Completion
2022-03-11

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736315 on ClinicalTrials.gov