Health Condition 1: C53- Malignant neoplasm of cervix uteri
Conditions
Interventions
Intervention1: Probiotic: Bacillus Clausii Spores suspension, 2 billion CFU/5ml vial, 2 times a day after food (morning and night) from starting the pelvic radiotherapy till 1 month after the completi
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1 Females aged eighteen to sixty years. 2 Patients with histologically proven carcinoma of the cervix, FIGO stage one B to stage four A, who have not previously received radiotherapy and are planned for pelvic radiotherapy. 3 Patients with adequate hematological parameters, defined as: 4 Neutrophil count greater than or equal to one thousand five hundred cells per cubic millimeter. 5 Platelet count greater than or equal to fifty thousand cells per cubic millimeter. 6 Hemoglobin greater than or equal to eight grams per deciliter. 7 Patients with adequate renal and hepatic function, defined as: 8 Serum creatinine less than one and a half times the upper limit of normal. 9 Alanine aminotransferase and aspartate aminotransferase are less than two and a half times the upper limit of normal. 10 Patients who are willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients will be excluded 1 If they underwent hysterectomy 2 Antibiotic intake in last 14 days 3 If they had participated in another clinical trial within 3 months 4 Any medical history considered as significant by the investigator 5 Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence and severity of radiotherapy-induced diarrhoea from the start to the end of the 10 week probiotic or Placebo treatment in two groups by using the Systemic Treatment Induced Diarrhea Assessment Tool (STIDAT)Timepoint: Baseline (before initiation of probiotic or placebo treatment), weekly during probiotic/placebo treatment, and at the end of the 10 week probiotic/placebo treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To compare the severity of radiotherapy induced abdominal pain from the start to the end of the 10 week probiotic or Plac,ebo treatment in two groups by using CTCAE criteria for abdominal pain 2 To assess the change in quality of life from the start to the end of the probiotic or placebo treatment, in two groups by using the Systemic Treatment Induced Diarrhea Assessment Tool STIDAT 3 Incidence of adverse events Timepoint: Baseline & weekly during probiotic or placebo treatment & at the end of the 10 week probiotic or placebo treatment | — |
Countries
India
Contacts
Public ContactDr M Padmaja
NIMS
Outcome results
None listed