The main objective of this research is the role of the Persumac( Iranian traditional medicine remedy) on refractory chemotherapy induced nausea and vomiting in breast cancer patients. We assess effect of Persumac on the number and severity of nausea and vomiting in acute and delayed phase.
Executive steps of study were:
1- Among patients referred for breast cancer, to the oncology clinic in Imam Reza hospital in Mashhad University of Medical Sciences; patients included in study who had at least one chemotherapy session and remain at least three sessions of Their chemotherapy sessions and had inclusion criteria.
2- The initial assessment of patients (Run- in): Concurrent with the visit of patient for chemotherapy (the first session of her/his chemotherapy in this study); also during interview, questionnaire was delivered. It took a full explanation of how to complete it and return the next session.
3- In the second session of chemotherapy (in this study); after eligibility qualification and obtaining consent form, patients randomly allocated into I-intervention(with Persmac- Bunium Persicum and Rhus Coriaria) and II- control( Lactose as Placebo) groups. The patients and researcher were blinded, In accordance with the study protocol, interventions take place. Questionnaire was delivered to the patient again.
4- (Wash out): Sixth day after the second session of chemotherapy until a day before the third session of chemotherapy determined as Wash out period.
5- In the third session of chemotherapy-in this study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again. The interval between each session of chemotherapy was two weeks. Finally data analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061822806N1
Registration date:2016-05-22, 1395/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-22, 1395/03/02
Registrant information
Name
Sadegh Shokri
Name of organization / entity
Birjand university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5833
Email address
shokris1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences and
Researcher
Expected recruitment start date
2015-10-03, 1394/07/11
Expected recruitment end date
2016-05-20, 1395/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iranian traditional medicine remedy compared with placebo on resistant chemotherapy induced nausea and vomiting in breast cancer
Public title
Effect of Iranian traditional medicine remedy on chemotherapy induced nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female, Definitive diagnosis of breast cancer by oncologists and a pathology report by pathologist, Age>18 years, History of chemotherapy induced nausea and vomiting resistant to conventional therapy, Normal tests for CBC, urea, creatinine, Alt, Ast, Bilirubin, FBS, Na, K, Have at least three sessions of chemotherapy ahead.
Exclusion criteria:
Total or upper abdominal radiation therapy along with chemotherapy- Taking anticoagulants, Use of other drugs/therapy for nausea and vomiting that not prescribed in this study, Hypersensitivity to Sumac or Bunium Persicum, Use of sumac and Bunium Persicum in seven days prior to the intervention, Diseases of the digestive system, Diseases that may associate with nausea and vomiting (such as hypertension, liver failure and kidney, digestive problems), Milk allergy, Losing of two consecutive or three intermittent doses of intervention.
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Random allocation and blinding was done this way: In the absence of research team, The laboratory expert, by using a computerized random number table,blindly allocated patients to intervention or control groups for second session chemotherapy in study. Hereafter, drug package codes were determined for patients. In cross over, the expert announced drug packages codes to researcher for delivery to the patients. Thus, this study is a randomized and double-blind.
Secondary Ids
1
Registry name
Thai Clinical Trials Registry
Secondary trial Id
TCTR20160401004
Registration date
2016-04-01, 1395/01/13
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethics committee of Mashhad University of Medical Sciences
Street address
University St., Ghoraishy Building
City
Mashhad
Postal code
91375-345
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.MUMS.REC.1394.495
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R-11
ICD-10 code description
Nausea and vomiting
2
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
3
Description of health condition studied
Follow-up examination after chemotherapy for other conditions
ICD-10 code
Z09.9
ICD-10 code description
Follow-up examination after unspecified treatment for other conditions
Primary outcomes
1
Description
Number of nausea in acute phase
Timepoint
Day 1 of intervention
Method of measurement
questionnaire
2
Description
Number of vomiting in acute phase
Timepoint
Day 1 of intervention
Method of measurement
questionnaire
3
Description
severity of nausea in acute phase
Timepoint
Day 1 of intervention
Method of measurement
Visual Analog Scale
4
Description
severity of vomiting in acute phase
Timepoint
Day 1 of intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Frequency of nausea in delayed phase
Timepoint
day 2-5 of intervention
Method of measurement
questionnaire
2
Description
Frequency of vomiting in delayed phase
Timepoint
day 2-5 of intervention
Method of measurement
questionnaire
3
Description
severity of nausea in delayed phase
Timepoint
day 2-5 of intervention
Method of measurement
Visual Analog Scale
4
Description
severity of vomiting in delayed phase
Timepoint
day 2-5 of intervention
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
2.7 gram Persumac,plus one drop of black zirah essential oil made in Adonis Goldaroo,three time daily half hour before meal with one glass cold water.
Category
Treatment - Drugs
2
Description
2.7 gram lactose, three time daily half hour before meal with one glass cold water