1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effect of combined ginger and quince on nausea and vomiting in cancer patients undergoing concurrent chemotherapy and radiotherapy

Protocol summary

Summary
Objectives: This study is aimed to determine the effect of the ginger-quince compound on nausea and vomiting of cancerous patients under chemotherapy and radiotherapy treatments at the same time. Design: This study is a Phase 3 clinical trial; a double blind, randomized, and controlled trial that will be performed in the Cancer Center of Imam Khomeini hospital. Setting and conduct : 240 cancerous patients undergoing chemotherapy and radiotherapy at the same time including 120 in each group, randomly prescribed standardized ginger and quince capsules or placebo three times a day, within 15 minutes of each meal, both starting from 3 days before chemotherapy until completion of radiotherapy period (six weeks). During treatment, the routine anti-vomiting protocol for all patients will be prescribed. Inclusion criteria:Suffering from cancer, definitely diagnosed by a pathologist; 18‏‎ year-old or more; under chemotherapy treatments; simultaneous radiotherapy treatments inducing ‎nausea and vomiting such as whole body or upper abdomen RT. Exclusion criteria: Warfarin and Heparin ‎treatment; ASA consuming more than 80 mg; history of‎ blood disorders; history of severe thrombocytopenia; allergy to ginger or consuming it during the ‎past week; gastro-intestinal cancers; having nausea and vomiting induced by factors except ‎chemotherapy or radiotherapy such as CNS tumors, HTN, renal failure or hepatic disorders; gastrointestinal ‎problems like gastric or peptic ulcers; forgetting the use of capsules three consecutive times or more. Intervention: Randomized prescription of standard ginger and quince capsules or placebo. Main outcome measures: During this period, intensity of nausea, vomiting times, duration of vomiting and nausea following chemotherapy and radiotherapy will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012113011615N1
Registration date: 2013-09-11, 1392/06/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Motahare Sadat Mousavian
Name of organization / entity
Medicin college, Tehran uiversity of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 21 81631
Email address
kazemian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cancer Research Center (Cancer Institute), Simorgh-e-Hekmat knowledge-base institute, Research vice-chancellor of Tehran university of medical sciences and health services
Expected recruitment start date
2013-03-15, 1391/12/25
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of combined ginger and quince on nausea and vomiting in cancer patients undergoing concurrent chemotherapy and radiotherapy
Public title
The effect of ginger-quince compound on nausea and vomiting induced by chemotherapy and radiotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Suffering from cancer; definitely diagnosed by a pathologist; 18‏‎ year-old or more; under chemotherapy treatments; simultaneous radiotherapy treatments inducing ‎nausea and vomiting such as whole body or upper abdomen RT. Exclusion criteria: Warfarin and Heparin ‎treatment; ASA consuming more than 80 mg; history of‎ blood disorders; history of severe thrombocytopenia; allergy to ginger or consuming it during the ‎past week; gastro-intestinal cancers; having nausea and vomiting induced by factors except ‎chemotherapy or radiotherapy such as CNS tumors, HTN, renal failure or hepatic disorders; gastrointestinal ‎problems like gastric or peptic ulcers; forgetting the use of capsules three consecutive times or more.
Age
From 18 years old to 149 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences and health services
Street address
floor 6, Central organization of university, Next to Qods St, Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
130/2133/د/91

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea severity
Timepoint
During the intervention, weekly
Method of measurement
Visual analogue scale

2

Description
Number of vomiting
Timepoint
During the intervention, weekly
Method of measurement
Data registration form

3

Description
Duration of vomiting
Timepoint
During the intervention, weekly
Method of measurement
Data registration form

4

Description
Duratin of nausea
Timepoint
During the intervention, weekly
Method of measurement
Data registration form

Secondary outcomes

empty

Intervention groups

1

Description
Cases is prescribed standardized ginger and quince capsules three times a day, within 15 minutes of each meal, starting from 3 days before chemotherapy until completion of radiotherapy period ( six weeks)
Category
Treatment - Drugs

2

Description
Control group is prescribed placebo three times a day, within 15 minutes of each meal, starting from 3 days before chemotherapy until completion of radiotherapy period ( six weeks)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini hospital
Full name of responsible person
Dr Ali Kazemian
Street address
Imam Khomeini hospital complex, Keshavarz Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research vice-chancellor, Tehran university of medical sciences and health services
Full name of responsible person
Dr Akbar Fotouhi
Street address
floor 6, Central organization of university, Next to Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellor, Tehran university of medical sciences and health services
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Cancer research center (Cancer Institute
Full name of responsible person
Dr Ali Kazemian
Street address
Imam Khomeini hospital complex, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cancer research center (Cancer Institute
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Simorgh-e-Hekmat knowledge-base institute
Full name of responsible person
Dr Hossein Rezaeizade
Street address
Unit 3, Issue 4, Gity Alley, Next to the Toloe pharmacy, Keshavarz Blvd, North Kargar St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Simorgh-e-Hekmat knowledge-base institute
Proportion provided by this source
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
Medicin college, Tehran university of medical sciences and health services
Full name of responsible person
Motahare ُُSadat Mousavian
Position
Medical student
Other areas of specialty/work
Street address
No 1, North door of Tehran university, Poursina St, Ghods St, Enghelab St
City
Tehran
Postal code
Phone
+98 21 81631
Fax
Email
m.mousavian145@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences and health services, Cancer research center (Cancer Institute)
Full name of responsible person
Dr Ali Kazemian
Position
Associate professor
Other areas of specialty/work
Street address
Imam Khomeini hospital complex, Keshavarz Blvd
City
Tehran
Postal code
1419733141
Phone
+98 21 6658 1571
Fax
+98 21 6693 5063
Email
kazemian@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medicin college, Tehran university of medical sciences and health services
Full name of responsible person
Motahare Sadat Mousavian
Position
Medical students
Other areas of specialty/work
Street address
No 1, North door of Tehran university, Poursina St, Ghods St, Enghelab St
City
Tehran
Postal code
Phone
+98 21 81631
Fax
Email
m.mousavian145@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...