Clinical trial NCT04426435: Effects a Honey Based Syrup on Blood Parameters in Patients With Breast Cancer
Official title: Honey Based Syrup on Blood Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
honey
blood
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2020-06-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The change of mean score of Hemoglobin level of patients in intervention and placebo groups
timeFrame: The weeks of 0 and 4 after treatment
measure: The change of mean score of WBC count of patients in intervention and placebo groups
timeFrame: The weeks of 0 and 4 after treatment
measure: The change of mean score of Plt count of patients in intervention and placebo groups
timeFrame: The weeks of 0 and 4 after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shohaday-e- Tajrish Hospital
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Mehdi Pasalar
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Zarshenas MM, Jafari P, Lankarani KB. Efficacy of jollab in the treatment of depression in dyspeptic patients: a randomized double-blind controlled trial. J Evid Based Complementary Altern Med. 2015 Apr;20(2):104-8. doi: 10.1177/2156587214563542. Epub 2015 Jan 13.
citation: Emtiazy M, Oveidzadeh L, Habibi M, Molaeipour L, Talei D, Jafari Z, Parvin M, Kamalinejad M. Investigating the effectiveness of the Trigonella foenum-graecum L. (fenugreek) seeds in mild asthma: a randomized controlled trial. Allergy Asthma Clin Immunol. 2018 May 2;14:19. doi: 10.1186/s13223-018-0238-9. eCollection 2018.
citation: Taavoni S, Fathi L, Nazem-Ekbatani N, Haghani H. The Effect of Oral Intake of Honey Syrup on the Pain Intensity of Active Phase of Parturition of nulliparous women: A Randomized clinical trial. Caspian J Intern Med. 2019 Winter;10(1):98-101. doi: 10.22088/cjim.10.1.98.