Objectives: Evaluating the efficacy of Malva sylvestris & Alcea digitata compound on prevention of radiation induced acute mucositis (OM) in head and neck cancer patients
Design: Randomized, double-blind, placebo-controlled clinical trial
Setting & Conduct: The study will be performed in one center and will include A herbal drug group and A placebo group. Each group will consist of 22 Head&Neck cancer patients with Radiotherapy (RT).
Major Inclusion criteria: patients with 17-65 years old in both sexes; candidate for radiotherapy for head & neck cancers; life expectancy over 1 year; Good performance status in ECOG questionnaire; At least 4 areas in RT fields
Major Exclusion criteria: Patients with organic & suppressive disorders; Use of drugs effective on salivary glands, cigar or alcohol; History of RT in last 6 months; Grade 3-4 Mucositis, candidiasis, oral herpes; Failure to treat, Hospitalization or need to TPN; Lack of interest in work
Intervention: Seven week administration of herbal drug or placebo (Avecil) sachets, will be conducted, 3 times a day. During the 7 weeks study, follow-up observations of primary and secondary outcomes will be performed.
Main outcome measures: The primary outcomes is presence/ absence and grade of OM, Severity of mouth pain on the visual analogue scale and OM-related quality of life on EORTC questionnaire. Secondary outcomes are side effects of drug and placebo. All outcomes will be measured at baseline, at each week of study to 2 weeks after RT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120520208N1
Registration date:2015-09-29, 1394/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-29, 1394/07/07
Registrant information
Name
Nasser Rezaeipour
Name of organization / entity
Medical Faculty of Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 7728 6873
Email address
n.rezaeipour@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced acute mucositis in head and neck cancer patients
Public title
Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced acute mucositis in head and neck cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with 17-65 years old in both sexes; candidate for radiotherapy for head & neck cancers; life expectancy over 1 year; Good performance status in ECOG questionnaire; At least 4 areas in RT fields Early
Exclusion criteria: Patients with organic & suppressive disorders; Use of drugs effective on salivary glands, cigar or alcohol; History of Rt in last 6 months; Grade 3-4 Mucositis, candidiasis, oral herpes; Failure to treat, Hospitalization or need to TPN; Lack of interest in work
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be divided to two groups with stratification form based at performance status, age (less and equal 50 and over 50 years old), and probable Simultaneous chemotherapy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University of Medical Sciences
Street address
Abdolahzadeh Ave. Keshavarz Boulvard
City
Tehran
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
41/215586
Health conditions studied
1
Description of health condition studied
Mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Mucositis
Timepoint
At the baseline, Weeks 1,2,3,4,5,6,7
Method of measurement
Examination of Oral Cavity
2
Description
Pain
Timepoint
At the baseline, Weeks 1,2,3,4,5,6,7
Method of measurement
Visual Analogue Scale
3
Description
Quality of Life
Timepoint
Weeks 1,2,3,4,5,6,7
Method of measurement
EORTC questionnaire
Secondary outcomes
1
Description
Side Effects
Timepoint
Weeks 1,2,3,4,5,6,7
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: 4 gram Sachets of Malva sylvestris & Alcea digitata compound (2 grams of each Herb); For 7 weeks; 3 times daily after meals
Category
Treatment - Drugs
2
Description
Control Group: 4 gram Sachets of Avecil; For 7 weeks; 3 times a day, after meals
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Ahmad Ameri
Street address
Shahid Madani St., Nezam Abad, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Opposite Imam Khomeini's Spulcher, Khalije Fars Exp Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahed University
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
Shahed University of Medical Sciences
Full name of responsible person
Nasser Rezaeipour
Position
PhD Student of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Shahed TIM clinic. Dashtestan 3 Ave. Pasdaran St.
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
drrezaeipour92@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Farhad Jafari, MD.
Position
Specialist of community medicine
Other areas of specialty/work
Street address
Abdollahzadeh Ave. Keshavarz Boulvard
City
Tehran
Postal code
Phone
+98 21 8896 4792
Fax
Email
jafarifarhaddr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Nasser Rezaeipour, MD
Position
PhD Student of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Shahed TIM clinic. Dashtestan 3 Ave. Pasdaran St.
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
drrezaeipour92@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)