Effects a Honey Based Syrup on Blood Parameters in Patients With Breast Cancer

Shiraz University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: honey based (HB) syrup

Study type

Interventional

Funder types

Other

Identifiers

NCT04426435

22145

Details and patient eligibility

About

Study aim Determination of the effect of a honey based (HB) syrup on the blood parameters of patients with breast cancer Design Two arm parallel group randomised clinical trial, double blinded Settings and conduct Design of the study: Women patients with breast cancer referring to Shohaday-e- Tajrish Hospital of Tehran who are under chemotherapy treatment. In order to blind the investigator, medications are named as "A" for syrup of HB and B for placebo. The patients don't aware of the type of drug they are assigned to. In addition, the groups are entered into statistical analysis as "A" and "B.

The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial demographic data would be gathered. Also, a blood sample would be drawn at the beginning time and after the end of intervention period (week 4).

Data would be analysed by SPSS software using T-test.

Full description

Women patients with breast cancer referring to Shohaday-e- Tajrish Hospital of Tehran who are under chemotherapy treatment. In order to blind the investigator, medications are named as "A" for syrup of HB and B for placebo. The patients don't aware of the type of drug they are assigned to. In addition, the groups are entered into statistical analysis as "A" and "B.

Data would be analysed by SPSS software using T-test. Main outcome variables The mean of score of "Hemoglobine (Hb)", 2. The mean of score of "white blood cell count (WBC)", 3. The mean of score of "platelet count (Plt)"

Main outcome variables The mean of score of "Hemoglobine (Hb)", 2. The mean of score of "white blood cell count (WBC)", 3. The mean of score of "platelet count (Plt)"

Participants/Inclusion and exclusion criteria Inclusion criteria: women suffer from breast cancer who are; 1.Age between 18- 70 years old; 2. Hemoglobin level is at least 8g/dl; 3. Hematocrit level at least 30%; 4. normal TSH. Exclusion criteria: 1. Heart disease with unstable conditions; 2. Disabling Pulmonary Disease and History of Asthma; 3. Severe kidney disease; 4. Creatinine level greater than 2mg/dl; 5. Proteinuria; 6. The SGOT level more than 3 times of the normal threshold; 7. Bilirubin levels greater than 2mg/dl; 8. Positive history of hypersensitivity to saffron, rose water and honey; 9. severe infection; 10. Systemic disease;11. Positive history of gout or high level of uric acid; 12. An individual who uses antidepressants due to depression; 13. Simultaneous use of drugs that affect fatigue; 14. Uncontrolled pain; 15. Unwillingness to participate in the study.

Enrollment

60 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female gender
Age between 18- 70 years old Patients
known case of breast cancer
Hemoglobin level is at least 8 g / dl
Hematocrit level at least 30% The level of
TSH is normal

Exclusion criteria

Patients known case of heart disease with unstable conditions
Disabling Pulmonary Disease and History of Asthma
Patients known case of severe kidney disease (Creatinine level is greater than 2mg / dl Proteinuria)
The SGOT level is more than 3 times of the normal threshold
Bilirubin levels is greater than 2mg / dl
Positive history of hypersensitivity to saffron, Rose water and Honey
Uncontrolled pain
severe infection
serious illness
Positive history of gout or high level of uric acid
An individual who uses antidepressants due to depression
Simultaneous use of drugs that affect blood cells
Unwillingness to participate in the study
Active treatment for anemia (transfusion or Epoetin Alfa Injection)