Breast CancerAIDNCT06214598
Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors
A study testing Supplement and AI diet in people with Breast Cancer, run by University of Belgrade at 2 sites in Serbia.
Trial summary
This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Supplement and AI diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesSerbia
- Study dates
- 1 Mar 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45 to 70 years
- Postmenopausal women
- Histologically confirmed BRC, stage I to IIIa
- ER positive /HER2 negative
- Application of adjuvant hormone therapy with aromase inhibitors: 6 to 30 months
- Body mass index from 20 to 34.9 kg/m 2
- Able to understand the requirements of the study and provide written information consent
Who cannot join
- Metastatic or locally advanced disease
- HER2-positive tumors
- Presence of other malignant or serious chronic diseases
- Active infections
- Previous stroke or heart attack,
- Rheumatoid arthritis and other types of autoimmune diseases
Show all 14Show fewer
- Presence of a significant neurological deficit
- Dementia
- Allergy to the ingredients of the dietary preparation or to fish, fish oil and nuts fruits.
- Allergies to evening primrose oil or other oils containing gamma-linolenic acid (borage, black currant)
- Use of lipid-lowering drugs (statins, Normolip)
- Current use of warfarin or other anticoagulants
- Corticosteroid therapy for the last month
- Use of dietary supplements based on fish oil, evening primrose, and flaxseed oils, omega 3-6-9 fatty acids, multivitamins with added omega-3 of fatty acids 3 months before the start of the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia2 sites, 2 recruiting
- Recruiting
Clinical Hospital Center Bezanijska kosa
Belgrade, 11070
Nebojsa Ivanovic, Dr, 0603947871, ivanovicnebojsadr@gmail.com
- Recruiting
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, 11129
Vesna Vucic, PhD, +381113031997, vesna.vucic.imr@gmail.com
Danijela Ristic Medic, MD PhD
About this study
Official title: Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.
Read the detailed description
With 2.1 million new breast cancer (BRC) cases each year globally, BRC is one of the biggest health challenges today. Available anticancer therapies have limited efficacy and are coupled with toxic side effects. Nutritional intervention can ameliorate undesirable effects, reduce exhaustion, psychological harm, and costs spent on treating these side effects. The proposed project AID aims to improve clinical outcome, quality of life (QoL) and survival rate in BRC patients on adjuvant endocrine therapy with aromatase inhibitors (AI) by nutritional interventions. In a three-arm randomised controlled nutritional trial involving 90 BRC patients who will receive either supplement or placebo pills (control group), or an anti-inflammatory diet for 4 months, along with the AI therapy, changes in nutritional status, QoL, biochemical and clinical parameters will be measured in comparison among three groups. The second goal is to establish cause-and-effect relationships among the clinical outcomes, nutritional status and biochemical parameters related to cancer, including inflammatory and redox status, plasma lipidome and polymorphism of fatty acid desaturase (FADS) genes. Introducing an effective nutritional intervention in BRC patients as an integral part of the multimodal therapeutic approach is the goal of this project.
- Conditions
- Breast Cancer
- Being tested
- Supplement, AI diet, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid
AI dietDietary supplement
diet rich in whole grains, healthy oils and polyphenols,
PlaceboDietary supplement
Placebo caps with standard diet
| Study group | Role | What they receive |
|---|---|---|
| AI Diet | Experimental | Personalised diet rich in whole grains high in fibres, vegetables (particularly leafy greens and tomatoes), polyphenol-rich fruits (berries), and n-3 FAs foods (fatty fish, nuts, seeds and oils) Receives: Dietary Supplement: AI diet |
| Supplements | Active comparator | 2 gel capsules/d of fish oil (FO) + 3 gel capsules/d of evening primrose oil (EPO), containing 600 mg EPA, 400 mg DHA and 351 mg GLA + Standard diet: 55% carbohydrate, 15% protein and 30% fats Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
assessed through blood cells count
Measured: baseline, 4 months, 1 year
Nutritional status
assessed through body mass index-BMI
Measured: baseline, 4 months, 1 year
Nutritional status
assessed through body composition- lean tissue, fat tissue and body water (in kg)
Measured: baseline, 4 months, 1 year
Changes in Quality of life
assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much).
Measured: baseline, 4 months
Changes in Quality of life
assessed through the questionnaires EORTC QLQ-C30. All items are scored on a 4-point categorical scale ranging from 1- not at al to 4- very much, except the two items of the global quality of life which use a modified 7-point linear analogue scale ranging from 1- very bad to 7- excellent.
Measured: baseline, 4 months
Changes in Quality of life
assessed through the questionnaires QLQ-BR23. All items are scored on a 4-point categorical scale ranging from 1- not at al to 4- very much.
Measured: baseline, 4 months
Clinical outcome
assessed through Laboratory analyses including BRC marker CA 15-3
Measured: baseline, 4 months, 1 year
Clinical outcome
assessed through potential complications and side-effects
Measured: baseline, 4 months, 1 year
Secondary outcomes (8)
Inflammatory status
levels of inflammatory markers IL-6, IL-8, IL-10 and TNF-α
Measured: baseline, 4 months,
Redox status
total antioxidant status (TAS), total advanced oxidation protein products (AOPP), total oxidant status (TOS), all in micromol/L
Measured: baseline, 4 months,
Redox status
superoxide dismutase (SOD)
Measured: baseline, 4 months,
Redox status
thiobarbituric acid reactive substances (TBARS)
Measured: baseline, 4 months,
leptin and adiponectin
plasma levels of leptin and adiponectin
Measured: baseline, 4 months
Fatty acid status
Fatty acid mol% of plasma phospholipids
Measured: baseline, 4 months
Lipidomic analysis
LC-MS lipids analysis
Measured: baseline, 4 months
FADS1/FADS2
Polymorphism of FADS1/FADS2 genes to test if the patient is homozygote with major or minor alleles or heterozygote for rs174537, rs174576 and rs174602
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AID project consists of a 3-arm clinical trial in BRC patients with 4-month nutritional intervention to assess the effects of personalized anti-inflammatory diet enriched with anti-inflammatory PUFA, or PUFA supplemental pills in 90 postmenopausal BRC patients receiving AI, randomly assigned in a ratio of 1:1:1 (diet:supplements:placebo). Since inflammation and oxidative stress are important promoters of cancer development and progression, we have chosen Fish oil and evening primrose oil as the richest sources of anti-inflammatory PUFA (n-3 and n-6). Anti-inflammatory diet enriched with PUFA and polyphenols was beneficial n many chronic diseases, and is named fatigue-reduction diet, especially relevant here as the fatigue is one of the most common side effects of AI. We will test the hypothesis that these interventions improve patients' nutritional status, QoL and clinical outcomes, by decreasing systemic inflammation and oxidative stress and reverting disrupted lipid metabolism.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesna Vucic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214598
- Sponsor's protocol ID
- AID5050
- Acronym
- AID
- Status last verified
- May 2024
- First submitted
- 14 Dec 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT06214598
- Acronym / sponsor ID
- AID / AID5050
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.
Detailed description
With 2.1 million new breast cancer (BRC) cases each year globally, BRC is one of the biggest health challenges today. Available anticancer therapies have limited efficacy and are coupled with toxic side effects. Nutritional intervention can ameliorate undesirable effects, reduce exhaustion, psychological harm, and costs spent on treating these side effects. The proposed project AID aims to improve clinical outcome, quality of life (QoL) and survival rate in BRC patients on adjuvant endocrine therapy with aromatase inhibitors (AI) by nutritional interventions. In a three-arm randomised controlled nutritional trial involving 90 BRC patients who will receive either supplement or placebo pills (control group), or an anti-inflammatory diet for 4 months, along with the AI therapy, changes in nutritional status, QoL, biochemical and clinical parameters will be measured in comparison among three groups. The second goal is to establish cause-and-effect relationships among the clinical outcomes, nutritional status and biochemical parameters related to cancer, including inflammatory and redox status, plasma lipidome and polymorphism of fatty acid desaturase (FADS) genes. Introducing an effective nutritional intervention in BRC patients as an integral part of the multimodal therapeutic approach is the goal of this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- AID project consists of a 3-arm clinical trial in BRC patients with 4-month nutritional intervention to assess the effects of personalized anti-inflammatory diet enriched with anti-inflammatory PUFA, or PUFA supplemental pills in 90 postmenopausal BRC patients receiving AI, randomly assigned in a ratio of 1:1:1 (diet:supplements:placebo). Since inflammation and oxidative stress are important promoters of cancer development and progression, we have chosen Fish oil and evening primrose oil as the richest sources of anti-inflammatory PUFA (n-3 and n-6). Anti-inflammatory diet enriched with PUFA and polyphenols was beneficial n many chronic diseases, and is named fatigue-reduction diet, especially relevant here as the fatigue is one of the most common side effects of AI. We will test the hypothesis that these interventions improve patients' nutritional status, QoL and clinical outcomes, by decreasing systemic inflammation and oxidative stress and reverting disrupted lipid metabolism.
| Arm | Type | Receives |
|---|---|---|
| AI Diet | Experimental | Dietary Supplement: AI dietPersonalised diet rich in whole grains high in fibres, vegetables (particularly leafy greens and tomatoes), polyphenol-rich fruits (berries), and n-3 FAs foods (fatty fish, nuts, seeds and oils) |
| Supplements | Active comparator | Dietary Supplement: Supplement2 gel capsules/d of fish oil (FO) + 3 gel capsules/d of evening primrose oil (EPO), containing 600 mg EPA, 400 mg DHA and 351 mg GLA + Standard diet: 55% carbohydrate, 15% protein and 30% fats |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboStandard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 45 to 70 years
- Postmenopausal women
- Histologically confirmed BRC, stage I to IIIa
- ER positive /HER2 negative
- Application of adjuvant hormone therapy with aromase inhibitors: 6 to 30 months
Key exclusion criteria (14 listed)
- Metastatic or locally advanced disease
- HER2-positive tumors
- Presence of other malignant or serious chronic diseases
- Active infections
- Previous stroke or heart attack,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementSupplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid | Dietary supplement | Supplements |
| AI dietdiet rich in whole grains, healthy oils and polyphenols, | Dietary supplement | AI Diet |
| PlaceboPlacebo caps with standard diet | Dietary supplement | Placebo |
Primary outcome
Nutritional status
Time frame: baseline, 4 months, 1 year
assessed through blood cells count
Nutritional status
Time frame: baseline, 4 months, 1 year
assessed through body mass index-BMI
Nutritional status
Time frame: baseline, 4 months, 1 year
assessed through body composition- lean tissue, fat tissue and body water (in kg)
Changes in Quality of life
Time frame: baseline, 4 months
assessed through the questionnaires FACT ES. The response scale is 5 point Likert-type scale (0- not at all, 4- very much).
Changes in Quality of life
Time frame: baseline, 4 months
assessed through the questionnaires EORTC QLQ-C30. All items are scored on a 4-point categorical scale ranging from 1- not at al to 4- very much, except the two items of the global quality of life which use a modified 7-point linear analogue scale ranging from 1- very bad to 7- excellent.
Changes in Quality of life
Time frame: baseline, 4 months
assessed through the questionnaires QLQ-BR23. All items are scored on a 4-point categorical scale ranging from 1- not at al to 4- very much.
Clinical outcome
Time frame: baseline, 4 months, 1 year
assessed through Laboratory analyses including BRC marker CA 15-3
Clinical outcome
Time frame: baseline, 4 months, 1 year
assessed through potential complications and side-effects
8 secondary outcomes
Inflammatory status
Time frame: baseline, 4 months,
Redox status
Time frame: baseline, 4 months,
Redox status
Time frame: baseline, 4 months,
Redox status
Time frame: baseline, 4 months,
leptin and adiponectin
Time frame: baseline, 4 months
Fatty acid status
Time frame: baseline, 4 months
Lipidomic analysis
Time frame: baseline, 4 months
FADS1/FADS2
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, Serbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement and AI diet in people with Breast Cancer, run by University of Belgrade at 2 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: baseline, 4 months, 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.