Clinical trial NCT02787707: Effect of Iranian Traditional Medicine Remedy on Chemotherapy Induced Nausea and Vomiting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea
Vomiting
Keywords: Breast cancer
Traditional medicine
Chemotherapy Induced Nausea and Vomiting
Bunium Persicum
Rhus Coriaria
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and Severity of nausea and vomiting in acute phase
timeFrame: first 24 hour after chemotherapy
Secondary outcomes:
measure: Frequency and Severity of nausea and vomiting in acute phase
timeFrame: Day 2-5 of chemotherapy
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences
state: Khorasan Razavi
Study officials:
affiliation: School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran
name: Mohammad Nazari, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.