IRCT | Evaluation the effect of complementary treatment with pistacia atlantica mouthwash on chemotherapy-induced mucositis (a double blind randomized placebo controlled clinical trial)

Protocol summary

Study aim: The main purpose of this study is to evaluate the effect of Pistacia Atlantica mouthwash on reducing severity of mucositis and xerostomia in patients receiving chemotherapy.
Design: In order to design this double blind study we randomly choose 30 patients with cancer (at least 18 years old without allergy to Pistacia Atlantica that not receiving complementary treatments like radiotherapy) receiving chemotherapy in Valie Asr hospital, Zanjan, Iran. Then we divide them into two groups of 15 person, one experimental and one control group.
Settings and conduct: In order to design this study we randomly choose 30 patients with cancer receiving chemotherapy in Valie Asr hospital, Zanjan, Iran. Then we divide them into two groups of 15 person, one experimental and one control group. All the members of both groups have to use MAGIC mouthwash as the basic treatment(3 times a day,each time 10 ml). Members of experimental group have to use Pistacia Atlantica mouthwash and members of control group have to use placebo in addition to that basic treatment (3 times a day,each time 10 ml). Then we evaluate the results of this study by examination of the participates in the first, third and seventh day of the study and re-evaluate them in terms of mucositis severity (using WHO system) and xerostomia severity (using Lickert's method).This study is double blind.(The researcher and participates are blinded)
Participants/Inclusion and exclusion criteria: Inclusion criteria: 1-Existence of chemotherapy-induced mucositis. 2-Participates must be at least 18 years old. 3-Not existence of serious dental problems or traumatic teeth or sharp-pointed cusps or fillings. 4-Not using of traumatic dentures. 5-Not using of anti-inflammatory agents or other mouthwashes during the study. 6-Absence of other systemic disease. Exclusion criteria: 1-Patients' inability to do the instructions of the protocol of the study. 2-Patients' death because of not responding to the cancer treatment. 3-Complementary treatments such as radiotherapy. 4-The history of allergy to pistacia atlantica. 5-The history of usage of cigarette,narcotics and alcohol.
Intervention groups: In order to design this study we randomly choose 30 patients with cancer receiving chemotherapy in Valie Asr hospital, Zanjan, Iran. Then we divide them into two groups of 15 person, one experimental and one control group. All the members of both groups have to use MAGIC mouthwash as the basic treatment(3 times a day,each time 10 ml). Members of experimental group have to use Pistacia Atlantica mouthwash and members of control group have to use placebo in addition to that basic treatment (3 times a day,each time 10 ml).
Main outcome variables: Oral mucositis intensity in participates using Pistacia Atlantica is different with that in participates using MAGIC mouthwash; Xerostomia intensity in participates using Pistacia Atlantica is different with that in participates using MAGIC mouthwash.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20160731029133N5

Registration date: 2018-01-30, 1396/11/10

Registration timing: registered_while_recruiting

Last update: 2018-01-30, 1396/11/10

Update count: 0
Registration date: 2018-01-30, 1396/11/10

Registrant information: Name

Neda Gholami

Name of organization / entity

Zanjan University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 21 7770 1401

Email address

dr.gholami.n@zums.ac.ir

Recruitment status: Recruitment complete
Funding source: Zanjan University of Medical Sciences

Expected recruitment start date: 2018-01-04, 1396/10/14
Expected recruitment end date: 2018-02-03, 1396/11/14
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation the effect of complementary treatment with pistacia atlantica mouthwash on chemotherapy-induced mucositis (a double blind randomized placebo controlled clinical trial)

Public title: Evaluation the effect of complementary treatment with pistacia atlantica mouthwash on chemotherapy-induced mucositis
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

1-Existence of chemotherapy-induced mucositis. 2-Participates must be at least 18 years old. 3-Not existence of serious dental problems or traumatic teeth or sharp-pointed cusps or fillings. 4-Not using of traumatic dentures. 5-Not using of anti-inflammatory agents or other mouthwashes during the study. 6-Absence of other systemic disease

Exclusion criteria:

1-Patients' inability to do the instructions of the protocol of the study. 2-Patients' death because of not responding to the cancer treatment. 3-Complementary treatments such as radiotherapy. 4-The history of allergy to pistacia atlantica. 5-The history of usage of cigarette,narcotics and alcohol.
Age: From 18 years old
Gender: Both

Phase

2-3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

We use Block Randomization with individual units in this study and we use sealed envelopes as randomization tool.

Blinding (investigator's opinion)

Double blinded

Blinding description

This is a double blind study.actually the researcher and the participates aren't aware of the grouping randomization process.In order to blind the researcher,instead of the researcher,one of the hospital doctors will put each participate into one of two groups randomly; and in order to blind participates we try to make the mouthwash and the placebo taste the same and prescribe in similar bottles.

Placebo

Used

Assignment

Parallel

Other design features

All the members of both groups have to use MAGIC mouthwash as the basic treatment.This mouthwash consists of: Aluminum-magnesium suspension 200 ml,Diphenhydramine Syrup 50 ml,One Lidocaine carpule,One Dexamethasone ampule,and a bottle of Nystatine.All the members of both groups have to gargle 10 ml of this mouthwash 30 seconds,3 times a day for 7 days.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Zanjan University of Medical Sciences

Street address

Zanjan University of Medical Sciences, Azadi Square

City

Zanjan

Province

Zanjan

Postal code

4515613191
Approval date: 2017-08-22, 1396/05/31
Ethics committee reference number: IR.ZUMS.REC.1396.137

Health conditions studied

1

Description of health condition studied: chemotherapy-induced mucositis
ICD-10 code: K12.3
ICD-10 code description: Oral mucositis (ulcerative)

2

Description of health condition studied: Xerostomia
ICD-10 code: K11.7
ICD-10 code description: Disturbances of salivary secretion

Primary outcomes

1

Description: Severity of oral mucositis
Timepoint: Before intervention, 3 days after beginning of the intervention, 7 days after beginning of the intervention(the last day of the intervention)
Method of measurement: WHO scoring system

2

Description: Severity of xerostomia
Timepoint: Before intervention, 3 days after beginning of the intervention, 7 days after beginning of the intervention(the last day of the intervention)
Method of measurement: Lickert's method

Secondary outcomes

empty

Intervention groups

1

Description: The members of the experimental group have to use Pistacia Atlantica mouthwash in addition to that basic treatment.This mouthwsh consists of: Humectant 5-20%(Glycerine-Sorbitol- propylene glycol),Surfactant 5%(Tween80 and sodium lauryl sulfate),a small am
Category: Treatment - Drugs

2

Description: The members of the control group have to use placebo in addition to basic treatment,to eliminate mental effects.(However they shoudn't know that this mouthwash is just a placebo.) Placebo consists of flavoring agents and water.the members of the control
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Vali Asr hospital

Full name of responsible person

Dr. Zahra Abbaspour Rad, Internist, Assisstant Professor

Street address

valiasr squre

City

Zanjan

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 1161

Email

dr.gholami.n@zums.ac.ir

1

Sponsor: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Dr. Neda Gholami

Street address

Zanjan Faculty of Dentistry, Shahrak Karmandan

City

Zanjan

Province

Zanjan

Postal code

4513956112

Phone

+98 24 3347 1161

Email

dr.gholami.n@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Zanjan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Dr. Neda Gholami

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Street address

Zanjan Faculty of Dentistry, Shahrak Karmandan

City

Zanjan

Province

Zanjan

Postal code

4513956112

Phone

+98 24 3347 1118

Fax

Email

dr.gholami.n@zums.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Dr. Neda Gholami

Position

Assistant Prof.

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Zanjan Faculty of Dentistry, Shahrak Karmandan

City

Zanjan

Province

Zanjan

Postal code

4513956112

Phone

+98 24 3347 1118

Fax

Email

dr.gholami.n@zums.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Yasaman Karbalaei

Position

Dentistry student

Latest degree

A Level or less

Other areas of specialty/work

Dentistry

Street address

shahrak karmandan

City

Zanjan

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 1161

Fax

Email

y.karbalaei@yahoo.com

Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: All datas will be published after blinding
When the data will become available and for how long: 2 m after publishing the results
To whom data/document is available: researchers working in scientific centers
Under which criteria data/document could be used: datas can be use for furture analysis
From where data/document is obtainable: zanjan dental school
What processes are involved for a request to access data/document: 1- written request ti research center 2- evaluation in reasearch councile. 3- 1 month
Comments

Evaluation the effect of complementary treatment with pistacia atlantica mouthwash on chemotherapy-induced mucositis (a double blind randomized placebo controlled clinical trial)