NCT02787707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

May 19, 2016

Last Update Submit

June 2, 2016

Conditions

NauseaVomiting

Keywords

Breast cancerTraditional medicineChemotherapy Induced Nausea and VomitingBunium PersicumRhus Coriaria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Frequency and Severity of nausea and vomiting in acute phase

    Day 2-5 of chemotherapy

Study Arms (2)

intervention

ACTIVE COMPARATOR

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

control

PLACEBO COMPARATOR

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

Drug: lactose

Interventions

PersumacDRUG

2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour

Also known as: Sumac and black Zirah
intervention
lactoseDRUG

2.7 grams Lactose every 8 hour

Also known as: Lactose powder
control

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of breast cancer,
  • Clinical diagnosis of chemotherapy induced nausea and vomiting resistant to conventional therapy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mashhad, Khorasan Razavi, Iran

Location

Related Publications (1)

  • 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.

    PMID: 28243404DERIVED

MeSH Terms

Conditions

NauseaVomitingBreast Neoplasms

Interventions

Lactose

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Mohammad Nazari, Ph.D

    School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D candidate of Persian medicine

Study Record Dates

First Submitted

May 19, 2016

First Posted

June 1, 2016

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Publication

Locations

IR(1)