Neoplasms

All Conditions

Head and Neck Neoplasms

Other Dietary Supplements

All Drugs and Chemicals

Amino Acids

Omega 3 Fatty Acid

Arginine

Standard medical nutrition therapy with Immunonutrition

Individualized dietary assessment and counselling with additional high energy, high protein, immunonutrient-enriched oral nutrition supplement; taken 3 servings per day, from 1 week prior to cancer treatment and continued throughout the cancer treatment.

Oral Impact® is an oral nutrition supplement product enriched with arginine (3.3g/sachet), omega-3 fatty acids (0.8g/sachet) and nucleotides (0.3g/sachet). The immunonutrient-enriched formula is also a complete and balanced formula, and is gluten free. The osmolality of the formula is 620 mOsm/kg water.

Immunonutrient-enriched oral nutrition supplementation

Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.

Standard medical nutrition therapy

Hazreen Abdul Majid, Prof. Dr.

Sing Ean Tan

Ibtisam Muhamad Nor

Nur Fadhlina Abdul Satar, Dr.

This is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (HNC) patients during cancer treatment.

The study population will be adult HNC patients receiving radiotherapy and chemotherapy treatment. The targeted number of subjects is 116 patients (58 subjects in each arm). Participants will be randomly assigned to receive standard medical nutrition therapy (individualized dietary assessment and counselling, and standard nutrition supplementation as necessary) or standard medical nutrition therapy with high energy, high protein, immunonutrient-enriched oral nutrition supplementation. Immunonutrition supplementation will begin 1 week prior to cancer treatment and continued throughout the cancer treatment, and to be taken in 3 servings/day. The study involves interviewing of subjects for dietary and nutrition assessment; measurement of weight, body composition, handgrip strength; and data collection from subjects' medical records.

Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study

Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study

Changes in body weight during study period

Changes in nutrition status during study period (3 categories: A- well nourished, B- moderately or suspected of being malnourished, and C- severely malnourished)

Changes in nutrition status during study period (score of 3 to 4 indicates risk of moderate malnutrition, and score of 5 to 9 indicates risk of severe malnutrition)

Changes in handgrip strength during study period

Changes in functional status during study period (score of 0 to 4; whereby 0- fully active and able to carry out all activities without any restrictions, and 4- completely disabled, unable to carry on any selfcare and confined to bed or chair)

University of Malaya

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Monoclonal Gammopathy of Undetermined Significance

Disease Progression

Smoldering Multiple Myeloma

Paraproteinemias

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Hypergammaglobulinemia

Precancerous Conditions

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Omega 3 supplement will be added to diet, 3 capsules per day for one month then 6 capsules per day for one month then 9 capsules per day as tolerated

Omega 3 supplementation will be initiated at three 1250 mg capsules daily for the first month. If dose is well tolerated, it will be increased to six 1250 mg capsules daily for 30 days, and finally to nine 1250 mg capsules daily. Treatment period is 12 months.

Wanda E Hardman, Ph.D.

Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance (MGUS), or Smoldering Multiple Myeloma (SMM), whose disease does not currently require treatment. The primary aim of the study is to determine if the Omega 3 supplementation will help prevent or delay progression of the disease to a stage that requires treatment.

Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)

Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies

Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.

Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.

Patients with MGUS or SMM were not enrolled into this study.

Edwards Foundation, Inc.

Marshall University

W. Elaine Hardman, Ph.D., Marshall University School of Medicine, Professor of Biochemistry and Microbiology

Serious adverse effects associated with omega 3 fatty acid consumption.

Adverse Effects

Omega 3 Supplementation

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. W. Elaine Hardman

Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.

Analysis based on global response.

Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.

Analysis based on High Initial NFkB Activation Expressers.

Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.

Analysis based on Low Initial NFkB Activation Expressers.

Total Population

Higher Initial Expressers

Lower Initial Expressers

Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.

Baseline Nuclear Factor Kappa B Activation

Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.

Nuclear Factor Kappa B Activation Following 3 Capsules Per Day

Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.

Nuclear Factor Kappa B Activation Following 6 Capsules Per Day

Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.

Nuclear Factor Kappa B Activation Following 9 Capsules Per Day

Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.

Nuclear Factor Kappa B Activation Post Supplement

NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods

Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 1

Fold Change in ALC-Patient 2

Fold Change in ALC-Patient 3

Fold Change in ALC-Patient 4

Fold Change in ALC-Patient 5

Fold Change in ALC-Patient 6

Fold Change in ALC-Patient 7

Fold Change in ALC-Patient 8

Fold Change in ALC-Patient 9

Fold Change in ALC-Patient 10

Fold Change in ALC-Patient 11

Fold Change in ALC-Patient 13

Fold Change in ALC-Patient 14

Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.

The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.

Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Oculocerebral Syndrome With Hypopigmentation

Anti-Inflammatory Agents

Omega 3 fatty acids for 6 months and then off omega 3 fatty acids for the next 6 months. In the first 6 months, you will be asked to take one capsule of Omega 3 fatty acids with breakfast and 1 with dinner/day for the first week, 2 capsules in the morning and one capsule in the evening for the second week and then 2 capsules with breakfast and 2 with dinner/day for the remaining 24 weeks. In the next 6 months (Months 7 to 12), you will have a blood test for markers of inflammation at the end of Month 7 and at Month 9 and 12 to determine if the anti-inflammatory effects of Omega 3 acids are still there after you have stopped taking it.

No Omega 3 fatty acids for the first 6 months followed by Omega 3 fatty acids for the next 6 months. You will be asked to have a blood test for markers of inflammation at Month 1, 3 and 6 for markers of inflammation to determine the natural variation of the levels of these markers without Omega 3 fatty acid supplements. In Month 7, you will be asked to take one capsule of Omega 3 with breakfast and 1 with dinner/day for the first week, 2 capsules in the morning and one capsule in the evening for the second week and then 2 capsules with breakfast and 2 with dinner/day for the remaining 24 weeks.

To evaluate the efficacy of 3.6 g omega 3 fatty acid supplements (2.4 g EPA + 1.2 g DHA)/day for 6 months versus no treatment at reducing the level of C-reactive protein (CRP) in ever smokers at high risk of lung cancer. The primary endpoint of the study is reduction of CRP.

Omega 3 fatty acid

Sukhinder Atkar-Khattra, BSc

Anne DyBuncio, BSc

Stephen Lam, MD

The study duration is 12 months. The initial enrollment visit will take approximately one hour. The Month 1, 3, 6, 7, 9 and 12 visits will take approximately 30 minutes each. The three telephone visits will take approximately 10 minutes each. The total time commitment to the study will be approximately four and a half hours.

The table below explains what will be done at each study visit:

Prior to Pre-Registration Informed Consent. Questionnaire (asking about your risks for lung cancer, diet and medications including food supplement). Blood test for CRP level

Prior to Registration/Randomization Blood test for CRP level (about 6 ml or 1 teaspoon) Pregnancy test (either blood or urine, for woman with childbearing potential only)

Registration/Randomization Medical history Physical exam (Vital signs/Body height and weight) Receive 3 month supply of Omega 3 fatty acids for treatment first group. Blood tests for Fasting Blood insulin, etc (about 15 ml or 3 teaspoons) Receive a diary to record the amount of study medication you take each day and any side effects you may experience

Week 2 telephone interview Ask about side effects you may be having Ask about other medications you may be taking Review study agent diary

Month 1 visit (you will not be able to eat anything for 10 hours before the appointment) Blood test for Fasting Blood insulin, etc (15 ml or 3 teaspoons) -( All participants)

Treatment Group:

Ask about side effects you may be having Ask about other medications you may be taking Review study medication diary

Month 2, 4, and 5 telephone interview Review diary Ask about side effects you may be having Ask about other medications you may be taking

Month 3 visit (you will not be able to eat anything for 10 hours before the appointment) Physical exam with vital signs Repeat blood tests (about 15 ml or 3 teaspoons) (All participants)

Treatment Group:

Collect unused omega 3 (for treatment group) Receive next 3 month supply of omega 3 (for treatment group) Review study medication diary Ask about side effects you may be experiencing Ask about other medications you may be taking

Month 6 or end of study visit (if left study early for any reason) Physical exam with vital signs Blood tests (about 15 ml or 3 teaspoons) - All participants

Treatment Group:

Review and collect study agent diary Ask about side effects you may be having Ask about other medications you may be taking

Month 7-12 Cross over study Treatment group will become observation group Observation group will become treatment group with the same procedures in month 1 to 6

participants are randomized into 2 study groups. Group 1 Omega 3 fatty acids for 6 months and then off omega 3 fatty acids for the next 6 months. Group 2. No Omega 3 fatty acids for the first 6 months followed by Omega 3 fatty acids for the next 6 months.

A computer will be used to select participants for each of the study groups.

Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers

A Phase II Randomized Cross-over Study of the Efficacy and Safety of Omega 3 Fatty Acid Supplements on Lung Cancer-Promoting Inflammatory Markers in Heavy Smokers

Individual participant data will not be shared with other researchers

Blood will be collected over the duration of the study

Lotte & John Hecht Memorial Foundation

British Columbia Cancer Agency

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Diabetes Mellitus

Depressive Disorder

Depressive Disorder, Major

Depression

Hypertension

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Psychotropic Drugs

Vasoconstrictor Agents

Desvenlafaxine Succinate

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Antidepressive Agents

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

Placebo (for Omega 3 fatty acid supplement)

Jayesh Kamath, MD PhD

To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes).

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.

Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.

UConn Health

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

2 subjects were randomized to this group

Desvenlafaxine + Omega 3 FA Supplement

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement)

3 subjects were randomized to this group

Desvenlafaxine + Placebo (for Omega 3 FA Supplement)

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

Age range: 53 to 66 years Gender: 1 male and 1 female

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement) Age range: 53 to 66 years \] Gender: 1 male and 2 females

Total

White Non-Hispanic/Latino

Race/Ethnicity, Customized

Due to very low enrollment in both arms, only descriptive analyses was completed for both arms

Jayesh Kamath MD PhD

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement)

Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Hospital Anxiety and Depression Scale

Montgomery-Asberg Depression Rating Scale (MADRS)

Short Form Health Survey (SF-12)

Visual Analog Scale for Energy (VAS-E)

Visual Analog Scale for Pain (VAS-P)

Leeds Sleep Evaluation Questionnaire (LSEQ)

Skin and Connective Tissue Diseases

Breast Neoplasms

Herbal and Botanical

Flax

English Walnut

fish oil

linseed oil

walnut oil

The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF)

recommend that babies be exclusively breastfed for the first 6 months from birth. The composition of breast

milk is dynamic and may vary according to the content of maternal nutrition. Maternal nutrition, on the other

hand, determines the quality of breast milk necessary for the adequate growth and health of infants. For this

reason, the content of the maternal diet is important during the lactation period, which is the critical stage that

can affect the development of infants.

Omega 3 fatty acids are essential unsaturated fatty acids that are not synthesized by the human body and must be obtained through diet. The polyunsaturated fatty acids (PUFAs) most abundant in the diet are short-chain omega 3 alpha linolenic acid (ALA) and omega 6 linoleic acid (LA), which are mostly found in vegetable oils. ALA is a plant-derived omega 3 fatty acid found in flaxseed, walnut, canola and soybean oils. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are found in marine sources such as seafood and fish oils. Today, the use of Omega 3 fatty acid supplements is increasing during the lactation period. However, consumption of omega 3 fatty acid sources during pregnancy or lactation is thought to be an important factor in preventing cancer risk. In our study, the investigators aimed to compare the maternal diet and the consumption of fish oil, flaxseed oil and walnut oil supplements during the lactation period, to compare the amount of prolactin and DHA in the milk composition and to compare the protective effects against breast cancer with cancer stem cell markers. For this study, 32 healthy Wistar pregnant rats, weighing 200-250 g, 8-10 weeks pregnant and not included in any experiments, will be used. Supplementary oils will be administered by oral gavage, considering the 0.5 g/kg body weight of the pregnant rats according to the groups they are assigned to, during the entire standard lactation period (day 21), considering the day of birth of the pregnant rats as the 0th day of lactation. Mother rats will be sacrificed under anesthesia at the end of the 21st day of lactation, mammary tissues will be taken into appropriate solutions and histopathological and immunohistochemical examinations will be performed. In addition, cardiac blood will be drawn and blood and tissue biochemical analyzes will be performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study	NCT05526040	Head and Neck C...	Immunonutrient-... Standard medica...	18 Years -	University of Malaya
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)	NCT00899353	Monoclonal Gamm... Smoldering Mult... Chronic Lymphoc...	Omega 3 Fatty A...	18 Years -	Marshall University
Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study	NCT05526040	Head and Neck C...	Immunonutrient-... Standard medica...	18 Years -	University of Malaya
Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers	NCT03936621	Lung Cancer	Omega 3 fatty a...	55 Years - 80 Years	British Columbia Cancer Agency
Omega 3 FA Supplements as Augmentation in the Treatment of Depression	NCT01803711	Major Depressio... Cancer Diabetes Cardiovascular ...	Desvenlafaxine Omega 3 Fatty a... Placebo (for Om...	18 Years -	UConn Health
Effect of OMEGA 3 Fatty Acids on Lactation Period	NCT06111378	Lactation Induc...	fish oil linseed oil walnut oil	8 Weeks - 10 Weeks	Celal Bayar University
Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study	NCT05526040	Head and Neck C...	Immunonutrient-... Standard medica...	18 Years -	University of Malaya

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