Effects a Honey Based Syrup on Blood Parameters in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): honey based (HB) syrup
Intervention type(s): Drug
Intervention description(s): honey-based syrup is prepared according to the documented Persian Medicine manuscripts with some modifications. HB is a mixture of honey, rose water and saffron. Each 100g of HB consisted of 79.87 g honey, 19.97 g rose water, and 0.16 g saffron.
All the ingredients were licensed and approved by The Islamic Republic of Iran Food and Drug Organization (I.R.I.FDO).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breast cancer; honey; blood