Effects of Chicory and Fumitory products on hot flashes in breast cancer patients

Effects of Chicory and Fumitory products in hot flashes of women with breast cancer referred to cancer clinic of shahid modarres hospital 2019-2021

Randomised clinical trial, Two arm parallel group design of 74 patients, Comparison between traditional medicine product and placebo

Firstly, we will evaluate the number and severity of hot flashes in first week of study as baseline and then, we will evaluate the number and severity of hot flashes in 4 weeks of intervention in two groups. Place of intervention: oncology clinic of shahid moddarres hospital

Inclusion criteria: Women between 18 and 65 years; Breast cancer (stage 0-3); At least two hot flashes in 24 hours; At least 4 weeks have elapsed since treatment with estrogen suppressive hormone therapy (Tamoxifen, LHRH agonists, Aromatase inhibitors) and continued unchanged until the end of the intervention. And conditions of non-entry: Lack of informed consent to the plan; Life expectancy is less than 6 months; Having another cancer at the same time as breast cancer; The patient is undergoing chemotherapy, radiotherapy or surgery; Taking antidepressants in the last 4 weeks; Use of acupuncture and complementary medicine (hypnosis, psychotherapy) Use of Anxiolytic drug, Gabapentin, Pregabalin, Clonidine, Aspirin, Vitamin E, Omega 3 and high phytoestrogenic diet; Drug allergy to venlafaxine; Allergy to distillated of Chicory and Fumitory; BUN, CR is not in normal laboratory range; Liver enzymes AST and ALT are more than twice the normal laboratory range and Total Billirubin ≥2

Group 1: Chicory and Fumitory products recipients Group II: placebo recipient

Number of Hot flashes, Severity of hot flash

In this study the restricted Randomization method of block randomization is used. Blocking is used to balance the number of samples assigned to each of the study groups. Randomization method was performed using balanced block randomization and in the form of 4 blocks using computer. Each drug is labeled with a number from 1 to 64. Patients were divided into two groups for the trial: the first group (32 people) intervention group or drug group and the second control group (32 people) placebo group. Both groups were equally divided in terms of characteristics and coordinated conditions. The control group is assigned to "A" and the intervention group to "B", and then these two groups are divided into 6 blocks of 4: (1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) AB BA, (6) BAAB .These blocks are randomly stacked together by a computer to form a chain of random groups (e.g. B B A A A A B B A B A B B A B A A B B A B A A B ) Patients then enter these groups in the order of enrollment. For randomization, a randomization tool for random sequence software called Random allocation software is used. In addition to simple randomization, this software is also able to generate random sequences by block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Drugs containing Chicory and Fumitory product or placebo were produced in the same shape and color and after coding were placed in sealed envelopes. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.

In this study, both chicory and fumitory products and placebo are made by the pharmacist in the laboratory and dumped and coded in similar batteries that only the pharmacist knows about the codes and in the same way it will be given for researchers and basis on randomization finally for participants both so the researcher and the participant are blinded.

Publishing results in form of a PhD thesis and an article indexing in ISI

After dissertation project thesis defence

Public

For research reasons

Shahid Beheshti University of Medical Sciences

Approving by responsible office