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

Sponsor
Mashhad University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02787707
Collaborator
(none)
69
Enrollment
1
Location
2
Arms
7
Duration (Months)
9.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences Mashhad Khorasan Razavi Iran, Islamic Republic of

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sadegh Shokri, Ph.D candidate of Persian medicine, Mashhad University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02787707
    Other Study ID Numbers:
    • MashhadUMS
    First Posted:
    Jun 1, 2016
    Last Update Posted:
    Jun 3, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sadegh Shokri, Ph.D candidate of Persian medicine, Mashhad University of Medical Sciences
    Breast cancer
    Traditional medicine
    Chemotherapy Induced Nausea and Vomiting
    Bunium Persicum
    Rhus Coriaria
    Additional relevant MeSH terms:
    Nausea
    Vomiting

    Study Results

    No Results Posted as of Jun 3, 2016