Clinical trial · Interventional
Omega-3 and Vitamin D Supplementation in Breast Cancer Women
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Omega-3 and Vitamin D Supplementation | Combination Product | — | UNRESOLVED |
| Omega-3 FA | Dietary Supplement | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group (A)
- description
- 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)
- interventionNames
- Dietary Supplement: Omega-3 FA
- type
- EXPERIMENTAL
- label
- Group (B)
- description
- 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).
- interventionNames
- Dietary Supplement: Vitamin D
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAlmassri HF, Abdul Kadir A, Srour M, Foo LH. The Effects of Omega-3 Fatty Acids and Vitamin D Supplementation on the Nutritional Status of Women with Breast Cancer in Palestine: An Open-Label Randomized Controlled Trial. Nutrients. 2024 Nov 20;16(22):3960. doi: 10.3390/nu16223960. PMID 39599746
- DERIVEDAlmassri HF, Abdul Kadir A, Srour M, Foo LH. The effects of Omega-3 fatty acids and vitamin D supplementation on the quality of life and blood inflammation markers in newly diagnosed breast cancer women: An open-labelled randomised controlled trial. Clin Nutr ESPEN. 2025 Feb;65:64-75. doi: 10.1016/j.clnesp.2024.11.014. Epub 2024 Nov 20. PMID 39577691