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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Persumac
lactose
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Breast cancer, Traditional medicine, Chemotherapy Induced Nausea and Vomiting, Bunium Persicum, Rhus Coriaria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention

control

Arm Description

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.

2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy.

Outcomes

Primary Outcome Measures

Frequency and Severity of nausea and vomiting in acute phase
number and severity of nausea and vomiting, acquired from questionnaire

Secondary Outcome Measures

Frequency and Severity of nausea and vomiting in acute phase
number and severity of nausea and vomiting, acquired from questionnaire

Full Information

First Posted
May 19, 2016
Last Updated
June 2, 2016
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02787707
Brief Title
Effect of Iranian Traditional Medicine Remedy on Chemotherapy Induced Nausea and Vomiting
Official Title
ٍ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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Breast cancer, Traditional medicine, Chemotherapy Induced Nausea and Vomiting, Bunium Persicum, Rhus Coriaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Persumac
Other Intervention Name(s)
Sumac and black Zirah
Intervention Description
2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour
Intervention Type
Drug
Intervention Name(s)
lactose
Other Intervention Name(s)
Lactose powder
Intervention Description
2.7 grams Lactose every 8 hour
Primary Outcome Measure Information:
Title
Frequency and Severity of nausea and vomiting in acute phase
Description
number and severity of nausea and vomiting, acquired from questionnaire
Time Frame
first 24 hour after chemotherapy
Secondary Outcome Measure Information:
Title
Frequency and Severity of nausea and vomiting in acute phase
Description
number and severity of nausea and vomiting, acquired from questionnaire
Time Frame
Day 2-5 of chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Nazari, Ph.D
Organizational Affiliation
School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication
Citations:
PubMed Identifier
28243404
Citation
Nazari M, Taghizadeh A, Bazzaz MM, Rakhshandeh H, Shokri S. Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial. Electron Physician. 2017 Jan 25;9(1):3535-3543. doi: 10.19082/3535. eCollection 2017 Jan.
Results Reference
derived

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

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