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

ٍ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

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.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting
• Intervention / Treatment: Drug: Persumac; Drug: lactose

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:

1. 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.
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); during interview, study questionnaire was delivered to patient. It took a full explanation of how to complete it and return the next session.
3. 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.
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 study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan Razavi
    • Mashhad, Khorasan Razavi, Iran, Islamic Republic of
      • Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Study Director: Mohammad Nazari, Ph.D, School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Breast cancer; Traditional medicine; Chemotherapy Induced Nausea and Vomiting; Bunium Persicum; Rhus Coriaria
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: MashhadUMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication