Clinical trial NCT05331807: Omega-3 and Vitamin D Supplementation in Breast Cancer Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer Female
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 88
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Nutritional status, as assessed by Body Mass Index
timeFrame: Change from Baseline BMI at 2 months
measure: Change of body weight
timeFrame: Change from Baseline Weight in kg at 2 months
measure: Change of Muscle Mass Status
timeFrame: Change from Baseline calf circumference in cm at 2 months
measure: Change of Nutritional Status Condition, as assessed by the Patient-Generated Subjective Global Assessment PG-SGA
timeFrame: Change from Baseline Nutritional Status Condition in category of well-nourished, moderately malnourished or severely malnourished at 2 months
measure: Change of Total Scale and Single-item measures Scores derived from the Quality of life questionnaire (QLQ C-30) assessment
timeFrame: Change from Baseline total scales and single-item measures scores (0 to 100 scores) at 2 months
measure: Change of Blood inflammatory markers of blood TNF-α levels
timeFrame: Change from baseline TNF-α levels in pg/mL at 2 months
measure: Change of Blood inflammatory markers of blood CRP levels
timeFrame: Change from baseline CRP levels in nmol/L at 2 months
measure: Change of Nutritional Status Assessed by body weight levels
timeFrame: Change from baseline weight in kg at 2 months
Secondary outcomes:
measure: Change of Dietary Energy Intakes
timeFrame: Change from Baseline dietary energy intakes in kcal at 2 months
measure: Change of Dietary Fat Intakes
timeFrame: Change from Baseline dietary fat intakes in grams at 2 months
measure: Change of Dietary Protein Intakes
timeFrame: Change from Baseline dietary Protein intakes in grams at 2 months
measure: Change of Dietary Vitamin D intakes
timeFrame: Change from Baseline Dietary Vitamin D Intakes in microgram at 2 months
measure: Lifestyle physical activity status
timeFrame: Change from Baseline Physical Activity Status (inactive, minimally active or active physical activity status) at 2 months
Other outcomes:
Locations:
city: Al-Zahra
country: Palestinian Territory, occupied
facility: Turkish-Palestinian Friendship Hospital
state: Gaza Strip
Study officials:
References: