Omega-3 and Vitamin D Supplementation in Breast Cancer Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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Group (A)

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)

Group Type EXPERIMENTAL

Omega-3 FA

Intervention Type DIETARY_SUPPLEMENT

Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA)

Group (B)

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).

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)

Group (C)

Participants will be received both omega-3 fatty acids capsules and vitamin D3 capsule. (one capsule of D3 50,000 IU weekly + two omega-3 fatty acids capsules daily (each capsule contains 300 mg of omega-3 fatty acids)

Group Type EXPERIMENTAL

Combined Omega-3 and Vitamin D Supplementation

Intervention Type COMBINATION_PRODUCT

Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA) and one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)

Group (D)

Participants will not be received any supplements and just receive oncology treatment as an usual oncology patient.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Omega-3 FA

Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA)

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)

Intervention Type DIETARY_SUPPLEMENT

Combined Omega-3 and Vitamin D Supplementation

Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA) and one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No