Evaluation the effectiveness of a mixture-syrup based on pomegranate and spearmint (Vomigramint), compared with placebo, on Chemotherapy induced nausea and vomiting (CINV) in breast cancer

Evaluation the effectiveness of a mixture syrup, based on pomegranate and spearmint (vomigramint), on chemotherapy induced nausea and vomiting in breast cancer

In this Double- blind, Parallel, randomized clinical trial , 60 eligible patients with breast cancer, referring to chemotherapy ward of Imam khomeini hospital, Sari, or Arian clinic, Amol, Iran, whom suffered from chemotherapy induced nausea and vomiting (CINV), (resistant to routine treatments), were selected purposefully. Participants were randomly divided into two arm parallel intervention and control group. Random allocation is done in the absence of research team, by statics expert of Mazandaran university of medical sciences, using a computerized random allocation software table tool. Hereafter, similar drug packages with different 4- digit codes were determined for patients by statics expert, using random allocation software. These codes are putted in envelopes, which then opened randomly, by research fellow, and drug or placebo with the same code is delivered to patients.

This study is about women with primary, non-metastatic breast cancer, whom suffered from resistant CINV, and will be done in chemotherapy ward of Imam khomeini hospital, Sari,and Arian clinic, Amol, in 5 months estimated period of time. This study is a double-blind, randomized, parallel clinical trial study in which patients and research fellow are blinded, by providing placebo, as similar as possible to drug, in smell, color, density, volume and containing bottle.

Inclusion criteria s: Documentary primary breast cancer diagnosis, At least 1 course of similar chemotherapy regimen is done, More than 18 years old, Experience of any degree of post chemotherapy nausea and vomiting, without dramatic response despite using routine anti-emetic drugs, At least two courses of chemotherapy is proceeding, Also Patient"s Satisfaction is prominently considered, Exclusion criteria s: Radiotherapy accompanying with chemotherapy simultaneously; Using anti-coagulant drugs in therapeutic dosage or having coagulation disorders; Using unusual or non permitted drugs or methods for treatment of nausea and vomiting other than intervention; Eating or hypersensitivity to pomegranate or spearmint in past week ; Having secondary or metastatic cancers; Nausea and vomiting by other secondary organic causes.

In intervention group, pomegranate and spearmint syrup (Vomigramint) is taken, three times a day, each time ten cc, with a glass of cool water, half an hour before each meal In control group, mixture of distilled water and eatable caramel syrup is taken, three times a day, each time ten cc, with a glass of cool water, half an hour before each meal

Severity of nausea; Frequency of vomiting in three different phases

Patients are randomly divided into two groups by using Block randomization method. Personalized randomization method is done by using random allocation software. Samples divided in ten blocks and six rows. Selection of random digits for blocks is done by random allocation software table tool. Drug and placebo are prepared for patients with similar specificity and different 4 digit numbers, assigned by statics expert e. Researcher and patients do not know about drug or placebo

Random allocation and blinding was done this way: In the absence of research team, The statics expert of Mazandaran university of medical sciences, by using a computerized random allocation software table tool, blindly allocated patients into intervention or control groups. Hereafter, drug package with 4- digit codes were determined for patients by research fellow. Thus, this study is a randomized and double-blind.