Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy
Phase II Randomized, Double Blind Study of Probiotics in Patients With Cervical Cancer in Clinical Stages IIB Undergoing Concurrent Chemotherapy and Radiation Therapy
1 other identifier
interventional
42
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2022
CompletedFirst Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedFebruary 21, 2023
February 1, 2023
2.2 years
January 31, 2023
February 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical toxicity
Toxicity was analyzed with the Common Toxicity Criteria Version 2. A grading (severity) scale is provided for each adverse event (AE) term. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Change from baseline up to 3 months after treatment finished
Secondary Outcomes (2)
Health Related Quality of Life
Change from baseline up to 3 months after treatment finished
Pro- and anti-inflammatory cytokines
Change from baseline up to 3 months after treatment finished
Study Arms (2)
Fermented dairy beverage
EXPERIMENTALConcumption of 3 servings of the fermented dairy beverage a day, during oncological treatment.
Placebo
PLACEBO COMPARATORConsumption of 3 servings of the placebo dairy beverage a day, during oncological treatment.
Interventions
Placebo dairy beverage (placebo) is a sweetened dairy beverage.
Eligibility Criteria
You may qualify if:
- Histological confirmation of cervical cancer staged as IIB.
- Histology: Epidermoid, adenosquamous, and adenocarcinoma
- Without previous treatment
- Measurable disease
- Age between 18 and 70 years
- Functional status of 0-2 (WHO criteria)
- Normal hematological, renal and hepatic function
- Standard chest X-ray
- Informed consent
You may not qualify if:
- Patients with small cell carcinoma or other rare histologies (sarcomas, lymphomas)
- Patients with other clinical stages
- Patients with paraaotic nodes less than or equal to 1 cm.
- Patients with non-measurable disease
- Infections or serious diseases that prevent the use of chemotherapy
- Concomitant treatment with another experimental drug
- Pregnancy or lactation
- Mental diseases
- Patients with previously documented hypersensitivity reactions to lactobacilli.
- Diabetic patients or hyperglycemia higher than 145 mg/dL.
- Previous or concomitant malignancy except non-melanoma skin carcinoma
- Social, family or geographical conditions that suggest a poor adherence to the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Cancerologíalead
- Yakult Honsha Co., LTDcollaborator
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirancollaborator
- Instituto Nacional de Perinatologiacollaborator
Study Sites (1)
National Cancer Institute of Mexico
Mexico City, Tlalpan, 14080, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucely Cetina Pérez, MD, PhD
Instituto Nacional de Cancerologia de Mexico
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 21, 2023
Study Start
April 25, 2005
Primary Completion
June 25, 2007
Study Completion
March 11, 2022
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share