The present study was conducted to evaluate the effects of probiotic and probiotic plus honey on radiation-induced diarrhea. Sixty-three adult patients with pelvic cancer who undergo radiotherapy for four weeks are enrolled. The presence of any acute or chronic gastrointestinal condition associated with diarrhea before recruitment and getting pelvic radiotherapy in the past are the exclusion criteria. They randomize to receive probiotic, probiotic plus honey or placebo from one week before radiotherapy for five weeks. Diarrhea grade and stool consistency are recorded weekly according to the Common Toxicity Criteria system and the Bristol scales, respectively. Also some hematological and immunological factors are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030421338N1
Registration date:2015-04-11, 1394/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-11, 1394/01/22
Registrant information
Name
Mahnaz Roayaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 7396
Email address
roayaei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences.
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Probiotics for the Prevention and Treatment of Radiation-induced Diarrhea in Patients with Cancer
Public title
Effects of Probiotics on diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: Patients with pelvic cancers (colorectal, prostate, endometrial, bladder, ovary, cervical, bone sarcoma) who undergo pelvic radiotherapy.
The exclusion criteria: The presence of any acute or chronic gastrointestinal condition associated with diarrhea before recruitment and getting pelvic radiotherapy in the past.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Center of Medical Research - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
81745319
Approval date
2012-10-17, 1391/07/26
Ethics committee reference number
491005
Health conditions studied
1
Description of health condition studied
Neoplasms
ICD-10 code
C17, C18,
ICD-10 code description
Malignant neoplasm of small intestine, Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum
Primary outcomes
1
Description
Diarrhea grade
Timepoint
Weekly from one week before radiotherapy until end of treatment
Method of measurement
Common Toxicity Criteria system
2
Description
Stool consistency score
Timepoint
Weekly from one week before radiotherapy until end of treatment
Method of measurement
Bristol scales
3
Description
Blood cell counts
Timepoint
Weekly from one week before radiotherapy until end of treatment
Method of measurement
cell counter machine
4
Description
Serum IgA level
Timepoint
Weekly from one week before radiotherapy until end of treatment
Method of measurement
Autoanalyzer machine
Secondary outcomes
1
Description
Bloting
Timepoint
Weekly during treatment
Method of measurement
Question from the patient
Intervention groups
1
Description
group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night)
Category
Treatment - Drugs
2
Description
group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening
Category
Treatment - Drugs
3
Description
group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening