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NCT Number: NCT02787707

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

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.

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Key information

Conditions

Nausea Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Mashhad, Razavi Khorasan Province, Iran

About this study

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:

  • 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.
  • 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.
  • 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.
  • (Wash out): Sixth day after the second session of chemotherapy until a day before the third session of chemotherapy determined as Wash out period.
  • In the third session of chemotherapy-in study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Persumac

Drug

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

Other names: Sumac and black Zirah

lactose

Drug

2.7 grams Lactose every 8 hour

Other names: Lactose powder

Primary outcomes

  1. Frequency and Severity of nausea and vomiting in acute phase

    Time frame: first 24 hour after chemotherapy

    number and severity of nausea and vomiting, acquired from questionnaire

Secondary outcomes

  1. Frequency and Severity of nausea and vomiting in acute phase

    Time frame: Day 2-5 of chemotherapy

    number and severity of nausea and vomiting, acquired from questionnaire

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2016
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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