The Effects of Combined Omega-3 and Vitamin D Supplementation on Nutritional Status, Quality of Life and Inflammatory Markers Among the Breast Cancer Women in Gaza Strip

21090645

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.

2022-04-20

2022-12-30

2023-03-31

Completed

Early phase I

88

Inclusion Criteria: * 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) Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An open-label randomized clinical trial of breast cancer women that are undergoing chemotherapy treatment for total duration of 2 months (approximately 9 weeks in total), in which participants will be randomly selected and included in either one of these four (4) experimental groups (arms).', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All eligible participants will be randomly selected and included in either one of these four (4) experimental groups (arms).The participants for each experimental will matched and stratified based on age group (± 5 years), menopausal status and BMI status (± 2 kg/m2). Each participant will be randomly allocated into four groups, based on their age, menopausal status and BMI status to ensure the standardization of general characteristics of study participants included in the study as a baseline data.'}}, 'enrollmentInfo': {'count': 88, 'type': 'ACTUAL'}}

2024-05-08