NCT05331807

Omega-3 and Vitamin D Supplementation in Breast Cancer Women

Completed EARLY_PHASE1 Last updated 8 May 2024

What this trial tests

EARLY_PHASE1 trial testing Omega-3 FA in Breast Cancer Female in 88 participants. Completed in 31 March 2023.

Timeline

20 April 2022

Primary endpoint
30 December 2022

31 March 2023

Quick facts

Lead sponsor	Universiti Sains Malaysia
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	88
Start date	20 April 2022
Primary completion	30 December 2022
Estimated completion	31 March 2023
Sites	1 location across Palestinian Territories

Drugs / interventions tested

• Omega-3 FA
• Vitamin D
• Combined Omega-3 and Vitamin D Supplementation

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

Universiti Sains Malaysia — full company profile →

Who can join

Adults 19 to 64, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
   Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x
2. Sarcopenia in chronic kidney disease: from bench to bedside.
   Kim DW, Song SH. · · 2023 · cited 18× · PMID 37077132 · DOI 10.3904/kjim.2022.338
3. Omega-3 fatty acids: molecular weapons against chemoresistance in breast cancer.
   Marchio V, Augimeri G, Morelli C, Vivacqua A, et al · · 2025 · cited 11× · PMID 39863855 · DOI 10.1186/s11658-025-00694-x
4. The advent of precision nutrigeroscience in cancer: from clinic towards molecular biology.
   Gao Z, Liu Y, Cui Y, Han Y, et al · · 2026 · cited 2× · PMID 40850675 · DOI 10.1016/j.jare.2025.08.034
5. 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.
   Almassri HF, Abdul Kadir A, Srour M, Foo LH. · · 2024 · cited 2× · PMID 39599746 · DOI 10.3390/nu16223960
6. 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.
   Almassri HF, Abdul Kadir A, Srour M, Foo LH. · · 2025 · cited 2× · PMID 39577691 · DOI 10.1016/j.clnesp.2024.11.014
7. The Effects of Vitamin D on the Breast Cancer Tumor Microenvironment.
   Kanwal B, Shah SS, Shaheen F, Shiferaw MS, et al · · 2025 · PMID 41374952 · DOI 10.3390/cancers17233751