Purpose: This study has been conducted to determine the effect of using oral rinse Peppermint Essence (PE) in prevention of chemotherapy-induced oral mucositis (OM). Materials & Methods: 40 patients with colon & rectum cancer, who admitted for chemotherapeutic management, were enrolled in a double blind clinical trial and they randomly divided in two equal, placebo & PE groups. They had to receive 10 drop of oral rinse PE or placebo, tree times a day, from the first day of chemotherapy up to the fourteenth day. Data tools included a bipartite questionnaire (demographic Q & clinical Q) and World Health Organization (WHO) scale for measurement of OM.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809222846N1
Registration date:2010-05-19, 1389/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-19, 1389/02/29
Registrant information
Name
Tahereh Ashktorab
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 1543
Email address
t_ashktorab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2009-12-11, 1388/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral rinse Peppermint Essence (PE) in prevention of chemotherapy- induced oral mucositis
Public title
The effect of oral rinse Peppermint Essence (PE) in prevention of chemotherapy- induced oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consciousness/literate/ admitted to hospital with colon or rectum cancer/ chemotherapeutic management with 5-fluorouracil / no stomatitis/ no oral disease/ no asthma/ no renal & liver disorders/ no auto immune disease and diabetes/ no fever and neutropenia/ no recieved antibiotic & narcotic analgesic/ no recieved another oral rinse /no mint family allergy.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The International Branch of Shahid Beheshti University of Medical Sciences
Street address
No. 19, Shaheed Abbas pour, Vali Asr
City
Tehran
Postal code
14155-3693
Approval date
2009-09-20, 1388/06/29
Ethics committee reference number
116/677
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K13
ICD-10 code description
Other diseases of lip and oral mucosa
Primary outcomes
1
Description
oral mucositis
Timepoint
daily
Method of measurement
observation with a check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: 10 drops of oral rinse Peppermint Essence, tree times a day, from the first day of chemotherapy up to the fourteenth day
Category
Prevention
2
Description
Control: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Emam Hosein hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Researcher
Full name of responsible person
Tahereh Ashktorab
Street address
Faculty of Nursing, Shahid Beheshti University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researcher
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of nursing , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Ashktorab
Position
PhD
Other areas of specialty/work
Street address
Faculty of nursing , Shahid Beheshti University of Medical Sciences, Shariati street
City
Tehran
Postal code
Phone
+98 21 2222 1543
Fax
Email
t_ashktorab@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Ashktorab
Position
PhD
Other areas of specialty/work
Street address
Faculty of nursing of Shahid Beheshti University of Medical Sciences, Shariati street
City
Tehran
Postal code
Phone
+98 21 2222 1543
Fax
Email
t_ashktorab@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Yazdani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
yazdani_za@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)