Effects of Tualang honey on quality of life and biochemical markers in breast cancer patients treated with anastrozole
Completed
- Conditions
- Breast cancer in postmenopausal womenCancerBreast cancer
- Registration Number
- ISRCTN89213965
- Lead Sponsor
- niversity of Science, Malaysia (Universiti Sains Malaysia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 84
Inclusion Criteria
Postmenopausal women treated with anastrozole and with breast cancer stages I, II and III estrogen receptor (ER+) positive and/or progesterone receptor (PR+) positive.
Exclusion Criteria
Any subject that has history of allergy to honey, severe infection, and/or receiving hormone and/or replacement therapy are excluded from this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Quality of life status by using Quality of Life Questionnaire-Core 36 (EQRTC-QLQ-C30)<br>2. Blood oxidative stress status by assessing the levels of malonaldehyde, total antioxidant status, protein carbonyl, reduced glutathione (GSH): oxidised glutathione (GSSG) ratio, erythrocyte superoxide dismutase, catalase, glutathione peroxidase using commercial kits<br>3. Blood breast cancer markers which include carcinoembryonic antigen and CA15-3 using commercial kits<br><br>All these outcomes are measured at baseline (Visit 1) and after 3 months (Visit 2)
- Secondary Outcome Measures
Name Time Method 1. Safety profile which include full blood count, fasting blood glucose, liver function test and renal function test<br>2. Blood inflammatory markers which include high-sensitive C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin 1ß (IL-1ß) and tumour necrosis factor- a (TNF- a) using commercial kits<br>3. Blood bone markers which include C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N propeptide (P1NP) using commercial kits<br>4. Blood estradiol using commercial kits<br><br>All these outcomes are measured at baseline (Visit 1) and after 3 months (Visit 2)