Omega-3 and Vitamin D Supplementation in Breast Cancer Women

May 6, 2024 updated by: Leng Huat Foo, Universiti Sains Malaysia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
Dietary supplement: Omega-3 FA
Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA)
Experimental: 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).
Dietary supplement: Vitamin D
one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)
Experimental: 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)
Combination product: 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)
No Intervention: Group (D)
Participants will not be received any supplements and just receive oncology treatment as an usual oncology patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Nutritional status, as assessed by Body Mass Index
Time Frame: Change from Baseline BMI at 2 months
Body weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Change from Baseline BMI at 2 months
Change of body weight
Time Frame: Change from Baseline Weight in kg at 2 months
Body weight will be measured in kilograms
Change from Baseline Weight in kg at 2 months
Change of Muscle Mass Status
Time Frame: Change from Baseline calf circumference in cm at 2 months
Muscle mass status will be assessed by calf circumference levels in cm. Higher values of calf circumference is indicative of greater lean mass.
Change from Baseline calf circumference in cm at 2 months
Change of Nutritional Status Condition, as assessed by the Patient-Generated Subjective Global Assessment PG-SGA
Time Frame: Change from Baseline Nutritional Status Condition in category of well-nourished, moderately malnourished or severely malnourished at 2 months
The PG-SGA will be based four components such as questions related to body weight status (scored 0-5), food intake (score 0-4); symptoms affecting oral food intake (scored 0-23), and lastly questions on daily activities and function, in which the degree of malnutrition of patients will be classified as (A) well-nourished; (B) moderately malnourished; or (C) severely malnourished.
Change from Baseline Nutritional Status Condition in category of well-nourished, moderately malnourished or severely malnourished at 2 months
Change of Total Scale and Single-item measures Scores derived from the Quality of life questionnaire (QLQ C-30) assessment
Time Frame: Change from Baseline total scales and single-item measures scores (0 to 100 scores) at 2 months
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) assessment of 30 questions to measure cancer patients' physical, psychological and social functions. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Change from Baseline total scales and single-item measures scores (0 to 100 scores) at 2 months
Change of Blood inflammatory markers of blood TNF-α levels
Time Frame: Change from baseline TNF-α levels in pg/mL at 2 months
Blood concentration of TNF-α levels will be measured in unit pg/mL.
Change from baseline TNF-α levels in pg/mL at 2 months
Change of Blood inflammatory markers of blood CRP levels
Time Frame: Change from baseline CRP levels in nmol/L at 2 months
Blood concentration of CRP levels will be measured in nmol/L
Change from baseline CRP levels in nmol/L at 2 months
Change of Nutritional Status Assessed by body weight levels
Time Frame: Change from baseline weight in kg at 2 months
Body weight will be measured in kilograms
Change from baseline weight in kg at 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Dietary Energy Intakes
Time Frame: Change from Baseline dietary energy intakes in kcal at 2 months
Habitual dietary nutrients intake will be assessed by mean energy intakes in kcal
Change from Baseline dietary energy intakes in kcal at 2 months
Change of Dietary Fat Intakes
Time Frame: Change from Baseline dietary fat intakes in grams at 2 months
Habitual dietary nutrients intake will be assessed by mean fat intakes in grams
Change from Baseline dietary fat intakes in grams at 2 months
Change of Dietary Protein Intakes
Time Frame: Change from Baseline dietary Protein intakes in grams at 2 months
Habitual dietary protein intakes will be assessed by mean protein intakes in grams
Change from Baseline dietary Protein intakes in grams at 2 months
Change of Dietary Vitamin D intakes
Time Frame: Change from Baseline Dietary Vitamin D Intakes in microgram at 2 months
Habitual dietary nutrients intake will be assessed by mean vitamin D intakes in micrograms
Change from Baseline Dietary Vitamin D Intakes in microgram at 2 months
Lifestyle physical activity status
Time Frame: Change from Baseline Physical Activity Status (inactive, minimally active or active physical activity status) at 2 months
A short form of the international physical activity questionnaire (IPAQ) will be used to assess the physical activity levels of the study participants, in which three different category groups of inactive, minimally active and active will be categorised.
Change from Baseline Physical Activity Status (inactive, minimally active or active physical activity status) at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21090645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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