Recurrent Breast CancerNCT01478477
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
A study testing omega-3 fatty acid supplement, Clinical assessments and Assessment of therapy complications in people with Recurrent Breast Cancer and Stage IA Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
- What is being tested?
- omega-3 fatty acid supplement, Clinical assessments and Assessment of therapy complications
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2011to 9 Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with breast cancer stages I-III initiating first adjuvant AI therapy with any of the Food and Drug Administration- (FDA) approved AIs (anastrozole, exemestane, letrozole)
- Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed
- Concurrent breast related radiation therapy is allowed
- Prior tamoxifen use is allowed
- Prior chemotherapy is allowed
- History of osteoarthritis and/or fibromyalgia is allowed
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Metastatic malignancy of any kind
- Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease, with the exception of osteoarthritis and fibromyalgia
- AI use > 2 weeks prior to study enrollment
- Known bleeding disorders
- History of diabetes mellitus, heart disease or TIA/stroke
- Current use of warfarin or other anticoagulants
Show all 13Show fewer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,or psychiatric illness/social situation that would limit compliance with study requirements
- Daily use of n-3 PUFA concentrates or capsules or regular or any other supplements that might interact with n-3 PUFA supplements within six months of study initiation; sporadic use of n-3 PUFA supplement may be eligible if there has been a 3-month washout period prior to randomization
- Pregnant or nursing women
- Known sensitivity or allergy to fish or fish oil
- Concurrent use of daily full dose aspirin (≥ 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month washout period is required prior to randomization
- Unable to give informed consent
- In patients consenting for optional MRIs, any contraindication to MRI examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study
This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.
Read the detailed description
OBJECTIVES:
- To assess the feasibility of evaluating joint symptoms in postmenopausal women with breast cancer randomized to n-3 PUFA (omega-3 fatty acid) vs. placebo supplementation using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale (FACT-ES), Brief Pain Inventory (BPI) and Stanford's Health Assessment -Disability Index (HAS) during the first 6 months of adjuvant aromatase inhibitor (AI) therapy.
II. To preliminarily evaluate the efficacy of n-3 PUFA vs. placebo supplementation on AI induced joint symptoms.
III. To explore blood and imaging based biomarkers (plasma and red blood cell [RBC] levels of n-3 PUFAs, inflammatory cytokines and receptors, and intra-articular tenosynovial inflammation by musculoskeletal magnetic resonance imaging [MRI] imaging) of AI-induced joint symptoms in women on AI therapy randomized to n-3 PUFAs vs. placebo supplementation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
- Conditions
- Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Being tested
- omega-3 fatty acid supplement, Placebo, Clinical assessments, Assessment of therapy complications, Magnetic Resonance Imaging
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acid supplementDietary supplement
Also called fish oil, omega fatty acid, O3FA, MNSG-194®
6 capsules per day (4.3 g)x 6 months
PlaceboOther
Also called PLCB, Typical American Diet oils, TAD
6 capsules per day (4.3 g)x 6 months. Supplement should be taken with food once per day. No specific food requirements are needed.
Clinical assessmentsOther
Also called Brief Pain Inventory, BPI, Stanford's Health Assessment-Disability Index, HAS
All three instruments will be administered at baseline, at 3 months, 6 months and at additional time intervals when there is a significant change in therapy (discontinuation/switch, pain medication administration) during routine medical oncology visits.
Assessment of therapy complicationsOther
Also called adverse events, toxicities, Expected Toxicities, Potential Toxicities
Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Optional bilateral hand and wrist MRI imaging will be obtained at baseline and at 6 months to eligible patients who have no contraindications to MRI imaging.
Correlative/special studiesProcedure or surgery
Also called laboratory studies
Plasma, RBC, and serum samples from the baseline blood draw will also be stored at -70C for fatty acid and biomarker analyses and repeated at 3 month and 6 month intervals. Samples will be analyzed in batches every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (omega-3 fatty acid supplement) | Experimental | Omega 3 Polyunsaturated Fatty Acids(n-3 PUFA) Receives: Dietary Supplement: omega-3 fatty acid supplement; Other: Clinical assessments; Other: Assessment of therapy complications; Procedure: Magnetic Resonance Imaging; Procedure: Correlative/special studies |
| Arm II (placebo) | Placebo comparator | Typical American Diet oils (TAD) Receives: Other: Placebo; Other: Clinical assessments; Other: Assessment of therapy complications; Procedure: Magnetic Resonance Imaging; Procedure: Correlative/special studies |
| Clinical Assessments | Experimental | Brief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES) Receives: Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo |
| Assessment of therapy complications | Experimental | Adverse events will be monitored by self-reporting of signs and symptoms. Patients will maintain a daily diary of time of supplement intake and any possible ill effects, with instructions to contact the PI or Research Nurse to discuss and manage any possible side effects. Receives: Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo |
| Magnetic Resonance Imaging | Experimental | Optional bilateral hand and wrist MRI imaging will be obtained Receives: Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo |
| Correlative/special studies | Experimental | Enrolled participants will have peripheral blood samples drawn for plasma and RBC n-3 PUFA levels within 4 weeks of starting AI therapy. Receives: Dietary Supplement: omega-3 fatty acid supplement; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument
Pain scores based on FACT-B/ES, HAS and BPI will be plotted over time for each arm. Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mass index, baseline pain scores (0 month), prior chemotherapy and other variables.
Measured: baseline, 6 months
Secondary outcomes (6)
Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments
Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mass index, baseline pain scores (0 month), prior chemotherapy and other variables.
Measured: baseline, 6 months
Compliance rates with oral supplements (omega-3 fatty acid and placebo)
Measured: baseline, 6 months
Feasibility of using the instruments HAS, BPI-short, FACT-B/ES for the assessment of joint symptoms
Measured: baseline, 6 months
Effectiveness of blinding
Summarized using a Chi-square test.
Measured: baseline, 6 months
Correlation of guess with pain scores
Checked using logistic models to see if treatment guesses are explained by the patient's awareness of clinical benefit.
Measured: baseline, 6 months
Relationship between serum and RBC omega-3 fatty acid levels, inflammatory blood markers and MRI changes and the joint symptoms
Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pair wise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study start4 Oct 2011
- Primary completion9 Jan 2014
- Study completion9 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer and Leukemia Group B
- Responsible party
- Principal investigator, Nicole Williams, Ohio State University Comprehensive Cancer Center
- Investigators
- Nicole Williams, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478477
- Sponsor's protocol ID
- OSU-11022
- Other IDs
- NCI-2011-03262
- Status last verified
- Feb 2023
- First submitted
- 14 Nov 2011
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orchard TS, Andridge RR, Yee LD, Lustberg MB. Diet Quality, Inflammation, and Quality of Life in Breast Cancer Survivors: A Cross-Sectional Analysis of Pilot Study Data. J Acad Nutr Diet. 2018 Apr;118(4):578-588.e1. doi: 10.1016/j.jand.2017.09.024. Epub 2017 Dec 9.
PubMed 29233615
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Aromatase Inhibitor-Induced Joint Symptoms With Omega 3 Fatty Acid Supplementation: a Randomized Placebo Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01478477
- Acronym / sponsor ID
- OSU-11022
- Conditions
- Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer and Leukemia Group B
- Study start
- 4 Oct 2011 (actual)
- Primary completion
- 9 Jan 2014 (actual)
- Study completion
- 9 Jan 2014 (actual)
- First posted
- 23 Nov 2011 (estimated)
- 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 randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole. Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.
Detailed description
OBJECTIVES:
- To assess the feasibility of evaluating joint symptoms in postmenopausal women with breast cancer randomized to n-3 PUFA (omega-3 fatty acid) vs. placebo supplementation using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale (FACT-ES), Brief Pain Inventory (BPI) and Stanford's Health Assessment -Disability Index (HAS) during the first 6 months of adjuvant aromatase inhibitor (AI) therapy.
II. To preliminarily evaluate the efficacy of n-3 PUFA vs. placebo supplementation on AI induced joint symptoms.
III. To explore blood and imaging based biomarkers (plasma and red blood cell [RBC] levels of n-3 PUFAs, inflammatory cytokines and receptors, and intra-articular tenosynovial inflammation by musculoskeletal magnetic resonance imaging [MRI] imaging) of AI-induced joint symptoms in women on AI therapy randomized to n-3 PUFAs vs. placebo supplementation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm I (omega-3 fatty acid supplement) | Experimental | Dietary Supplement: omega-3 fatty acid supplement, Other: Clinical assessments, Other: Assessment of therapy complications, Procedure: Magnetic Resonance Imaging, Procedure: Correlative/special studiesOmega 3 Polyunsaturated Fatty Acids(n-3 PUFA) |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Clinical assessments, Other: Assessment of therapy complications, Procedure: Magnetic Resonance Imaging, Procedure: Correlative/special studiesTypical American Diet oils (TAD) |
| Clinical Assessments | Experimental | Dietary Supplement: omega-3 fatty acid supplement, Other: PlaceboBrief Pain Inventory (BPI), Stanford's Health Assessment-Disability Index (HAS), FACT-B and endocrine subscale (FACT-ES) |
| Assessment of therapy complications | Experimental | Dietary Supplement: omega-3 fatty acid supplement, Other: PlaceboAdverse events will be monitored by self-reporting of signs and symptoms. Patients will maintain a daily diary of time of supplement intake and any possible ill effects, with instructions to contact the PI or Research Nurse to discuss and manage any possible side effects. |
| Magnetic Resonance Imaging | Experimental | Dietary Supplement: omega-3 fatty acid supplement, Other: PlaceboOptional bilateral hand and wrist MRI imaging will be obtained |
| Correlative/special studies | Experimental | Dietary Supplement: omega-3 fatty acid supplement, Other: PlaceboEnrolled participants will have peripheral blood samples drawn for plasma and RBC n-3 PUFA levels within 4 weeks of starting AI therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women diagnosed with breast cancer stages I-III initiating first adjuvant AI therapy with any of the Food and Drug Administration- (FDA) approved AIs (anastrozole, exemestane, letrozole)
- Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed
- Concurrent breast related radiation therapy is allowed
- Prior tamoxifen use is allowed
- Prior chemotherapy is allowed
Key exclusion criteria (13 listed)
- Metastatic malignancy of any kind
- Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease, with the exception of osteoarthritis and fibromyalgia
- AI use > 2 weeks prior to study enrollment
- Known bleeding disorders
- History of diabetes mellitus, heart disease or TIA/stroke
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 |
|---|---|---|
| omega-3 fatty acid supplementAlso: fish oil, omega fatty acid, O3FA, MNSG-194®6 capsules per day (4.3 g)x 6 months | Dietary supplement | Arm I (omega-3 fatty acid supplement), Assessment of therapy complications, Clinical Assessments, Correlative/special studies, Magnetic Resonance Imaging |
| PlaceboAlso: PLCB, Typical American Diet oils, TAD6 capsules per day (4.3 g)x 6 months. Supplement should be taken with food once per day. No specific food requirements are needed. | Other | Arm II (placebo), Assessment of therapy complications, Clinical Assessments, Correlative/special studies, Magnetic Resonance Imaging |
| Clinical assessmentsAlso: Brief Pain Inventory, BPI, Stanford's Health Assessment-Disability Index, HASAll three instruments will be administered at baseline, at 3 months, 6 months and at additional time intervals when there is a significant change in therapy (discontinuation/switch, pain medication administration) during routine medical oncology visits. | Other | Arm I (omega-3 fatty acid supplement), Arm II (placebo) |
| Assessment of therapy complicationsAlso: adverse events, toxicities, Expected Toxicities, Potential ToxicitiesSeverity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). | Other | Arm I (omega-3 fatty acid supplement), Arm II (placebo) |
| Magnetic Resonance ImagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingOptional bilateral hand and wrist MRI imaging will be obtained at baseline and at 6 months to eligible patients who have no contraindications to MRI imaging. | Procedure or surgery | Arm I (omega-3 fatty acid supplement), Arm II (placebo) |
| Correlative/special studiesAlso: laboratory studiesPlasma, RBC, and serum samples from the baseline blood draw will also be stored at -70C for fatty acid and biomarker analyses and repeated at 3 month and 6 month intervals. Samples will be analyzed in batches every 6 months. | Procedure or surgery | Arm I (omega-3 fatty acid supplement), Arm II (placebo) |
Primary outcome
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument
Time frame: baseline, 6 months
Pain scores based on FACT-B/ES, HAS and BPI will be plotted over time for each arm. Agreement between HAS, BPI-short and FACT-B/ES evaluated using Altman and Bland plot after proper data transformation. Also, Linear Mixed model used to explore if the pain scores are different at 3 and 6 months. Logistic regression models used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups, with potential covariates including age, body mass index, baseline pain scores (0 month), prior chemotherapy and other variables.
6 secondary outcomes
Pain score change after 6 months (6 months -baseline) based on the HAS and BPI instruments
Time frame: baseline, 6 months
Compliance rates with oral supplements (omega-3 fatty acid and placebo)
Time frame: baseline, 6 months
Feasibility of using the instruments HAS, BPI-short, FACT-B/ES for the assessment of joint symptoms
Time frame: baseline, 6 months
Effectiveness of blinding
Time frame: baseline, 6 months
Correlation of guess with pain scores
Time frame: baseline, 6 months
Relationship between serum and RBC omega-3 fatty acid levels, inflammatory blood markers and MRI changes and the joint symptoms
Time frame: baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 29233615Orchard TS, Andridge RR, Yee LD, Lustberg MB. Diet Quality, Inflammation, and Quality of Life in Breast Cancer Survivors: A Cross-Sectional Analysis of Pilot Study Data. J Acad Nutr Diet. 2018 Apr;118(4):578-588.e1. doi: 10.1016/j.jand.2017.09.024. Epub 2017 Dec 9.
- JameslineLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Nicole Williams, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acid supplement, Clinical assessments and Assessment of therapy complications in people with Recurrent Breast Cancer and Stage IA Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 13 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: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score change after 6 months (6 months -baseline) based on the FACT-B/ES instrument (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478477, which also lists 1 linked publication.
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 27 Feb 2023.