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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787707
• Other study ID #: MashhadUMS
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2016
• Last updated: June 2, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Persumac
2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour
• lactose
2.7 grams Lactose every 8 hour

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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