Effect of Iranian Traditional Medicine Remedy on Chemotherapy Induced Nausea and Vomiting

Study Overview
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Brief Summary
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The main objective of this research is the role of the Persumac(an Iranian traditional remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting in acute and delayed phase.

Detailed Description
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The study was a double-blind, placebo controlled, Cross-over clinical trial of Iranian traditional remedy (Persumac) on chemotherapy induced nausea and vomiting in breast cancer patients. From October 2015 to May 2016, sample selection continued to be until the full sample size. Executive steps of study: Among patients referred for breast cancer, to the oncology clinic in Imam Reza hospital in Mashhad University of Medical Sciences, an oncology referral center in the North East of Iran; patients included in study who had at least one chemotherapy session and remain at least three sessions of Their chemotherapy cycle and had inclusion criteria. 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); during interview, study questionnaire was delivered to patient. It took a full explanation of how to complete it and return the next session. In the second session of chemotherapy (in study); after eligibility qualification and obtaining consent form, patients randomly allocated into intervention and control groups, In accordance with the study protocol, interventions take place. Questionnaire was delivered to the patient again. (Wash out): Sixth day after the second session of chemotherapy until a day before the third session of chemotherapy determined as Wash out period. In the third session of chemotherapy-in study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again.

Official Title
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ٍEffect of Iranian Traditional Medicine Remedy Compared With Placebo on Chemotherapy Induced Nausea and Vomiting in Breast Cancer; a Double-blind Randomized Controlled Cross-over Clinical Trial

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Persumac
* Drug: lactose


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical diagnosis of breast cancer, Clinical diagnosis of chemotherapy induced nausea and vomiting resistant to conventional therapy. Exclusion Criteria: Clinical diagnosis of hypersensitivity to Sumac or Bunium Persicum, Clinical diagnosis of digestion disorders, Clinical diagnosis of non chemotherapy induced nausea and vomiting, Milk allergy, Clinical diagnosis of bleeding diathesis, Clinical diagnosis of non-breast cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour from 24 hour before to fifth day after chemotherapy. | Drug: Persumac<br>* 2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour<br>* Other names: Sumac and black Zirah;|
| Placebo Comparator: control<br>2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy. | Drug: lactose<br>* 2.7 grams Lactose every 8 hour<br>* Other names: Lactose powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Severity of nausea and vomiting in acute phase | number and severity of nausea and vomiting, acquired from questionnaire | first 24 hour after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Severity of nausea and vomiting in acute phase | number and severity of nausea and vomiting, acquired from questionnaire | Day 2-5 of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Traditional medicine, Chemotherapy Induced Nausea and Vomiting, Bunium Persicum, Rhus Coriaria