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

NCT ID: NCT05736315

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-25
• Study Completion Date: 2022-03-11

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).

Detailed Description

Globally, many cancer survivors have undergone radiotherapy (RT) to pelvic tumors, this confers an 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).

In Mexico, the incidence of cervical cancer is 23 cases in 100,000 women (2015, Secretaría de Salud). In the Mexican National Cancer Institute (Instituto Nacional de Cancerología; INCan), 80% of patients arrive at locally advanced stages (IB2-IVA), the standard treatment is based on CRT. Gastrointestinal symptoms experienced by patients that receive pelvic RT define the pelvic radiation disease (PRD). Acute PRD is the result of cell death in the crypt epithelium and an acute inflammatory response in the lamina propria, which results in an insufficient replacement of the villi, rupture and inflammation of the mucosal barrier. Symptoms develop in 60-80% of patients. These include nausea, diarrhea, tenesmus, abdominal pain, urgency, anorexia, bleeding and fatigue; these are dose-limiting symptoms and affect the patients' quality of life.

A recent study analyzed the microbiota of LACC patients and found that patients that develop PRD during treatment with CRT possess a different microbiota to those patients that do not develop severe gastrointestinal toxicity. Evidence points to the critical role that the microbiota and intestinal inflammation play for the development of PRD in LACC patients. Therefore, an optimal intervention that modulates the microbiota is essential. We aimed to investigate the effect that a dairy beverage fermented with the probiotic Lactobacillus casei Shirota may have on intestinal and systemic inflammation, and consequently gastrointestinal symptoms and quality of life in women with LACC, undergoing CRT.

METHODS. This study was a double blind, placebo-controlled trial for Stage IIB cervical cancer patients that underwent CRT. The intervention group consumed of 3 servings of the fermented dairy beverage (Yakult) a day. The control group consumed 3 servings of the placebo beverage (with the same organoleptic qualities of Yakult). Clinical toxicity was analyzed with the Common Toxicity Criteria Version 2. Quality of Life score was measured with the QLQC 30 EORTC questionnaire. Fecal calprotectin was quantified to determine intestinal inflammation. Pro- and anti-inflammatory cytokines were quantified in blood samples to determine systemic inflammation.

Conditions

Cervical Cancer, Stage IIB

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Fermented dairy beverage

Concumption of 3 servings of the fermented dairy beverage a day, during oncological treatment.

Group Type: EXPERIMENTAL

Placebo dairy beverage

Intervention Type: OTHER

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

Placebo

Consumption of 3 servings of the placebo dairy beverage a day, during oncological treatment.

Group Type: PLACEBO_COMPARATOR

Placebo dairy beverage

Intervention Type: OTHER

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

Interventions

Placebo dairy beverage

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

Intervention Type: OTHER

Other Intervention Names

Probiotic

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yakult Honsha Co., LTD

INDUSTRY

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: collaborator

Instituto Nacional de Perinatologia

OTHER_GOV

Sponsor Role: collaborator

National Institute of Cancerología

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Lucely Cetina Pérez

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucely Cetina Pérez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia de Mexico

Locations

National Cancer Institute of Mexico

Mexico City, Tlalpan, Mexico

Countries

Mexico

Other Identifiers

008/043/ICI

Identifier Type: -

Identifier Source: org_study_id