Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy
Condition: Cervical Cancer, Stage IIB
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Placebo dairy beverage
Intervention type(s): Other
Intervention description(s): Placebo dairy beverage (placebo) is a sweetened dairy beverage.
Other intervention name(s): Probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cervical cancer; Probiotics; Toxicity; Inflammation; Quality of Life