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

Phase 2

Completed

• Conditions: Vomiting; Nausea
• Interventions: Drug: Persumac; Drug: lactose

• Registration Number: NCT02787707
• Lead Sponsor: Mashhad University of Medical Sciences

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:

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 Timeline

• Study Start: 2015-10
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-27
• Status Verified: 2016-06
• Study First Posted: 2016-06-01
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intervention	Persumac	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.
control	lactose	2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy.

Primary Outcome Measures

Name	Time	Method
Frequency and Severity of nausea and vomiting in acute phase	first 24 hour after chemotherapy	number and severity of nausea and vomiting, acquired from questionnaire

Secondary Outcome Measures

Name	Time	Method
Frequency and Severity of nausea and vomiting in acute phase	Day 2-5 of chemotherapy	number and severity of nausea and vomiting, acquired from questionnaire

Trial Locations

Locations (1)

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