Effects of Chicory and Fumitory products on hot flashes

Phase 2

Recruiting

Conditions: Breasts cancer.
Malignant neoplasm of breast
CD50

Registration Number: IRCT20210226050506N1

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 64

Inclusion Criteria

Women between 18 and 65 years
Breast cancer (stage 0-3)
Having 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)
Estrogen suppressive hormone therapy continued unchanged until the end of the intervention

Exclusion Criteria

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
Use of acupuncture and complementary medicine (hypnosis, psychotherapy)
Taking antidepressants in the last 4 weeks
Use of Anxiolytic drug, Gabapentin, Pregabalin, Clonidine, Aspirin, Vitamin E, Omega 3, Phytoestrogenic supplements
Use of high phytoestrogenic diet
Allergy to distillated of Chicory and Fumitory
Kidney test (BUN,CR) is not in normal range
Laboratory range Liver enzymes AST and ALT are more than twice the normal range
Laboratory range and Total Bilirubin =2

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of hot flashes: This variable registered by patient based on definied daily in hot flashes daily registration form. Timepoint: At a specific time of night, it is recorded daily and continuously for one week before the intervention and four weeks during the intervention with drug or placebo. Method of measurement: Number of hot flashes average of frequency during a week according to based on Daily Hot flashes Diary.;The severity of hot flashes in four levels , mild , moderate, severe and very severe, is recorded according to the definition registered by the patient in the Daily hot flashes Diary. Timepoint: At a specific time of night, it is recorded daily and continuously for one week before the intervention and four weeks during the intervention with drug or placebo. Method of measurement: Based on the weekly average daily hot flashes intensity based on the Daily hot flashes Diary.

Secondary Outcome Measures