Omega-3 and Vitamin D Supplementation in Breast Cancer Women
- Conditions
- Breast Cancer Female
- Interventions
- Combination Product: Combined Omega-3 and Vitamin D SupplementationDietary Supplement: Omega-3 FADietary Supplement: Vitamin D
- Registration Number
- NCT05331807
- Lead Sponsor
- Universiti Sains Malaysia
- Brief Summary
Breast cancer (BC) is the most common malignant disease, which is fifth leading cause of cancer mortality worldwide. Poor nutritional status is one of the common physical symptoms found among cancer patients, in which it is caused by both cancer disease state and its oncology treatment regimens used. Cancer patients develop a tumor-associated malnutrition characterized by an insufficient supply of macro- and micronutrients and systemic chemotherapy treatment that could significantly affecting the nutritional status of these patients by its side effects associated with chemotherapy that may lead to many medical complications that often requires hospitalization and death. An adequate nutritional intervention can have a beneficial impact on the disease condition and also the progress of the disease, as an integral part of adjuvant therapy on cancer care. Numerous studies had shown that the use of EPA and DHA are safe (absence of cardiotoxic effects) and effective in reducing the common chemotherapy-related side effects, such as bone density loss, peripheral neuropathy and weight gain. The question remains arises to whether administration of both vitamin D and omega-3 fatty acids supplementations could be used as important nutritional strategy during the active oncology treatment in breast cancer patients. In Palestine, nutritional intervention strategies are poorly evaluated in the oncology setting especially among patients undergoing chemotherapy. Suitable and proper nutritional interventions among breast cancer patients during active oncology treatments could help to improve nutritional status, decrease mortality and improve quality of life among these subjects. Hence, the present study is formulated to assess the effect of combined omega-3 fatty acid and vitamin D supplementation on the nutritional status, quality of life and blood inflammatory markers among breast cancer women undergoing chemotherapy treatment in the Gaza Strip, Palestine.
- Detailed Description
An adequate nutritional intervention can have a beneficial impacts on the disease condition and also the progress of the disease, as an integral part of adjuvant therapy on cancer care. Numerous clinical and epidemiological studies had found that vitamin D deficiency is common nutritional disorder in BC patients and that significantly associated with a negative prognostic factor, in which some have reported a positive effect of combining vitamin D or its analogues as an adjuvant therapy, together with a variety of chemotherapeutic factors used during oncology treatments. Moreover, combination of vitamin D and omega-3 fatty acids may provide a new complementary treatment by decreasing inflammatory biomarkers and resistance to cancer treatment in patients with BC. The question remains whether vitamin D and omega-3 fatty acids co-supplementation would actually be useful after diagnosis of BC. So, the aim of this study is to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, and nutritional status in patients with BC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 88
- Females who have been newly diagnosed with the breast cancer of stage I, II and III
- Patients with following clinical diagnosis of breast cancer such as lymph node positive +ve, hormonal receptor negative -ve and human epidermal growth factor receptor 2 (HER2) negative -ve
- Patient will receive her first chemotherapy treatment with Adriamycin + Cytoxan (AC) for a total of four cycle (each cycle will be carried-out every 3 weeks (21 days)
- Participants who had already undertaken her chemotherapy previously, and/or other oncology treatments such as hormonal or radiation oncology therapy
- Patients with recurrent breast cancer, patients with other chronic disease conditions such as renal disease and under dialysis, HIV, malabsorption disorder diseases, autoimmune diseases, diabetes, hypertension, hepatic, parathyroid, and gastrointestinal disorders.
- Patients who have reported any allergy condition to fish and/or fish products
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group (C) Combined Omega-3 and Vitamin D Supplementation Participants will be received both omega-3 fatty acids capsules and vitamin D3 capsule. (one capsule of D3 50,000 IU weekly + two omega-3 fatty acids capsules daily (each capsule contains 300 mg of omega-3 fatty acids) Group (A) Omega-3 FA Participants will be received daily omega-3 fatty acid (two capsules of 1000mg fish oil daily). Each soft gel capsule contains 300 mg of omega-3 fatty acids in the bioactive triglyceride (TG) and 180mg EPA and 120 mg DHA. (Omega3 complex, Jamieson Laboratories, Canada) Group (B) Vitamin D Participants will be received only vitamin D (one capsule of 50,000IU weekly). Each film coated tablet of vitamin D contains 50,000 IU Vitamin D3 (Cholecalciferol). (J-Dee, Jerusalem Pharmaceutical Company, West bank, Palestine).
- Primary Outcome Measures
Name Time Method Change of Blood inflammatory markers of blood TNF-α levels Change from baseline TNF-α levels in pg/mL at 2 months Blood concentration of TNF-α levels will be measured in unit pg/mL.
Change of Nutritional Status Assessed by body weight levels Change from baseline weight in kg at 2 months Body weight will be measured in kilograms
Change of Muscle Mass Status Change from Baseline calf circumference in cm at 2 months Muscle mass status will be assessed by calf circumference levels in cm. Higher values of calf circumference is indicative of greater lean mass.
Change of Blood inflammatory markers of blood CRP levels Change from baseline CRP levels in nmol/L at 2 months Blood concentration of CRP levels will be measured in nmol/L
Change of Nutritional status, as assessed by Body Mass Index Change from Baseline BMI at 2 months Body weight in kilograms and height in meters will be combined to report BMI in kg/m\^2
Change of body weight Change from Baseline Weight in kg at 2 months Body weight will be measured in kilograms
Change of Total Scale and Single-item measures Scores derived from the Quality of life questionnaire (QLQ C-30) assessment Change from Baseline total scales and single-item measures scores (0 to 100 scores) at 2 months The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) assessment of 30 questions to measure cancer patients' physical, psychological and social functions. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Change of Nutritional Status Condition, as assessed by the Patient-Generated Subjective Global Assessment PG-SGA Change from Baseline Nutritional Status Condition in category of well-nourished, moderately malnourished or severely malnourished at 2 months The PG-SGA will be based four components such as questions related to body weight status (scored 0-5), food intake (score 0-4); symptoms affecting oral food intake (scored 0-23), and lastly questions on daily activities and function, in which the degree of malnutrition of patients will be classified as (A) well-nourished; (B) moderately malnourished; or (C) severely malnourished.
- Secondary Outcome Measures
Name Time Method Change of Dietary Protein Intakes Change from Baseline dietary Protein intakes in grams at 2 months Habitual dietary protein intakes will be assessed by mean protein intakes in grams
Lifestyle physical activity status Change from Baseline Physical Activity Status (inactive, minimally active or active physical activity status) at 2 months A short form of the international physical activity questionnaire (IPAQ) will be used to assess the physical activity levels of the study participants, in which three different category groups of inactive, minimally active and active will be categorised.
Change of Dietary Energy Intakes Change from Baseline dietary energy intakes in kcal at 2 months Habitual dietary nutrients intake will be assessed by mean energy intakes in kcal
Change of Dietary Vitamin D intakes Change from Baseline Dietary Vitamin D Intakes in microgram at 2 months Habitual dietary nutrients intake will be assessed by mean vitamin D intakes in micrograms
Change of Dietary Fat Intakes Change from Baseline dietary fat intakes in grams at 2 months Habitual dietary nutrients intake will be assessed by mean fat intakes in grams
Trial Locations
- Locations (1)
Turkish-Palestinian Friendship Hospital
🇵🇸Al-Zahra, Gaza Strip, Palestinian Territory, occupied