Table 1 Clinical trials using ω-3 PUFAs and chemotherapeutic drugs in patients with breast cancer registered at https://clinicaltrials.gov (accessed on 16 June 2024)
From: Omega-3 fatty acids: molecular weapons against chemoresistance in breast cancer
Study | Phase | State | Intervention/treatment | Eligibility criteria, primary outcome, and purpose | Results |
|---|---|---|---|---|---|
NCT02352779 | N/A | Completed with results | -Low-dose of ω-3 PUFAs orally (PO) twice daily (BID) and placebo PO BID for 6 weeks -High-dose ω-3 PUFA supplementation PO BID for 6 weeks -Placebo | Eligibility criteria: women with confirmed diagnosis of breast cancer and who had undergone some type or combination of standard adjuvant treatment having cancer-related fatigue. Primary outcome: cancer-related fatigue and Multidimensional Fatigue Symptom Inventory-Short Form. Purpose: to investigate the effects of ω-3 PUFAs in reducing cancer-related fatigue in BC survivors | [138] |
NCT01821833 | N/A | Completed | – ω-3 PUFA capsules orally beginning 1 week prior to paclitaxel treatment – Placebo prior to paclitaxel treatment | Eligibility criteria: patients having a diagnosis of breast cancer or ovarian cancer who are scheduled to receive weekly paclitaxel at 70–90 mg/m2 for a minimum of 2 months; ECOG performance status of 0, 1, or 2. Primary outcome: mean severity of pain, incidence of pain, or relief. Purpose: to determine whether ω-3 PUFAs reduce pain in patients with breast or ovarian cancer receiving paclitaxel |  |
NCT05331807 | Early phase I | Recruiting | – Two capsules of ω-3 PUFAs daily – One capsule of vitamin D3 weekly – Two capsules of ω-3 PUFAs and one capsule of vitamin D3 weekly | Eligibility criteria: women with newly diagnosed stage I–III BC who will receive treatment with adriamycin and cytoxan for a total of four cycles. Primary outcome: changes in body mass index, body weight, muscle mass status, nutritional status condition, total scale, and single-item measures scores, blood inflammatory markers. Purpose: to assess the effect of combined ω-3 PUFAs and vitamin D supplementation on nutritional status, quality of life, and blood inflammatory markers among women with BC undergoing chemotherapy treatment in the Gaza Strip, Palestine |  |
NCT01823991 | Early phase I | Completed | – COGNUTRIN (40% polyphenolics, 12.5% anthocyanins from blueberries and omega-3) for 3 months – Placebo | Eligibility criteria: women with stage II–IIIA breast cancer who have completed adjuvant treatment with anthracyclines and taxanes + or − radiation therapy within the past 6 months and do not show any evidence of dementia. Primary outcome: cognitive function score changes. Purpose: to investigate the safety and the influence of COGNUTRIN on cognitive performance in BC survivors following chemotherapy |  |
NCT01049295 | 4 | NA | – 640 mg oral oil fish pearls (54% DHA, 10% EPA) three times a day – Placebo | Eligibility criteria: women with invasive breast cancer, not receiving any form of supplementations and oil fish. Primary outcome: serum level of ω-3 PUFAs before chemotherapy with taxanes and after 3 months. Purpose: to evaluate the effects of ω-3 PUFAs on taxane-induced neuropathy and inflammation in patients with invasive BC |  |
NCT02795572 | 2 | Terminated | – Daily dose of vitamin D 2000 IU, vitamin B6 100 mg, vitamin B12 100 mcg, and ω-3 PUFAs 2700 mg – Placebo | Eligibility criteria: women aged between 18 and 70 with invasive breast carcinoma receiving docetaxel. Primary outcome: chemotherapy induced peripheral neuropathy assessment. Purpose: to evaluate the effects of nutraceuticals, including ω-3 PUFAs, in patients treated with docetaxel as neoadjuvant or adjuvant BC therapy |  |
NCT02517502 | Early phase 1 | Completed | – 400 mg capsules of DHA daily – Placebo | Eligibility criteria: women aged 45–70 years with stage I–III invasive breast cancer who will start neoadjuvant chemotherapy. Primary outcome: evaluation of the proportion of eligible subjects agreeing to participate in the study and successfully complete the cognitive assessments. Number of subjects reporting serious adverse effects. Purpose: to investigate whether DHA administered prior to and in combination with neoadjuvant chemotherapy is able to prevent or reduce the cognitive dysfunction induced by chemotherapy |  |