Breast CancerPhase 3NCT02269696
The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients
A Phase 3 study testing Metoprolol and Normal saline in people with Breast Cancer, run by Kuopio University Hospital.
Trial summary
The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the incidence of pain and life satisfaction will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Metoprolol and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2018to 21 Mar 2018
- Phase
- Phase 3
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective breast surgery due to breast cancer
- Voluntary
- BMI ≥ 18 and ≤ 35 kg/m2
- ASA 1-3
- No regular use of beta-blockers or during the last 72 hours
- No contraindications to beta-blockers
Who cannot join
- Pregnancy or breast feeding
- AV-block, degree II or III
- Untreated cardiac insufficiency
- Sinus bradycardia, heart rate < 45 / min or symptoms
- Sick sinus syndrome
- Cardiogenic shock
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- Severe peripheral vascular disorder
- Systolic blood pressure < 100 mmHg
- Long PQ-time, > 0,24 seconds
- Known hypersensitivity to beta-blockers or the ingredients of the drug
About this study
The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the incidence of pain and life satisfaction will be evaluated.
Read the detailed description
The purpose of the study is to test the effects of intraoperative metoprolol on 1) anaesthetic and alagesic use 2) pain during the early postoperative period and 3) the incidence of pain and lide satisfaction up to 12 months after the surgery. Adverse effects will be recorded as safety measures.
- Conditions
- Breast Cancer
- Being tested
- Metoprolol, Normal saline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called Seloken
Intraoperative metoprolol infusion.
Normal salineDrug
Also called NaCl 0,9%
Equal of volume compared to metoprolol.
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol | Experimental | Metoprolol infusion Receives: Drug: Metoprolol |
| Normal saline | Placebo comparator | Equal volume of saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaesthesia
Total consumption of desflurane
Measured: Intraoperative
Anaesthesia
Total consumption of remifentanil
Measured: Intraoperative
Postoperative pain
Total analgesics consumption
Measured: First 4 postoperative hours
Postoperative pain
Time to analgesics
Measured: First 4 postoperative hours
Postoperative pain
Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement
Measured: First 4 postoperative hours
Long-term pain
The incidence and the level of pain at 3 months
Measured: 3 months
Long-term pain
The incidence and the level of pain at 12 months
Measured: 1 year
Secondary outcomes (5)
Safety and tolerability
Number of patients with adverse effects
Measured: Perioperative
Distribution to the central nervous system
Cerebro spinal fluid and blood samples
Measured: Perioperative
Life satisfaction
Life satisfaction in a Likerts scale
Measured: 1 year
Anxiety
Spielberg State-Trait Anxiety Inventory
Measured: 1 year
Depression
Beck Depression Inventory
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start21 Mar 2018 (estimated)
- Primary completion21 Mar 2018 (estimated)
- Study completion21 Mar 2018 (estimated)
Why it stopped: Withdrawn
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Harkanen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269696
- Sponsor's protocol ID
- KUH5101090
- Status last verified
- Mar 2018
- First submitted
- 19 Sep 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02269696
- Acronym / sponsor ID
- KUH5101090
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 21 Mar 2018 (estimated)
- Primary completion
- 21 Mar 2018 (estimated)
- Study completion
- 21 Mar 2018 (estimated)
- First posted
- 21 Oct 2014 (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.
The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the incidence of pain and life satisfaction will be evaluated.
Detailed description
The purpose of the study is to test the effects of intraoperative metoprolol on 1) anaesthetic and alagesic use 2) pain during the early postoperative period and 3) the incidence of pain and lide satisfaction up to 12 months after the surgery. Adverse effects will be recorded as safety measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol | Experimental | Drug: MetoprololMetoprolol infusion |
| Normal saline | Placebo comparator | Drug: Normal salineEqual volume of saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elective breast surgery due to breast cancer
- Voluntary
- BMI ≥ 18 and ≤ 35 kg/m2
- ASA 1-3
- No regular use of beta-blockers or during the last 72 hours
Key exclusion criteria (10 listed)
- Pregnancy or breast feeding
- AV-block, degree II or III
- Untreated cardiac insufficiency
- Sinus bradycardia, heart rate < 45 / min or symptoms
- Sick sinus syndrome
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 |
|---|---|---|
| MetoprololAlso: SelokenIntraoperative metoprolol infusion. | Drug | Metoprolol |
| Normal salineAlso: NaCl 0,9%Equal of volume compared to metoprolol. | Drug | Normal saline |
Primary outcome
Anaesthesia
Time frame: Intraoperative
Total consumption of desflurane
Anaesthesia
Time frame: Intraoperative
Total consumption of remifentanil
Postoperative pain
Time frame: First 4 postoperative hours
Total analgesics consumption
Postoperative pain
Time frame: First 4 postoperative hours
Time to analgesics
Postoperative pain
Time frame: First 4 postoperative hours
Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement
Long-term pain
Time frame: 3 months
The incidence and the level of pain at 3 months
Long-term pain
Time frame: 1 year
The incidence and the level of pain at 12 months
5 secondary outcomes
Safety and tolerability
Time frame: Perioperative
Distribution to the central nervous system
Time frame: Perioperative
Life satisfaction
Time frame: 1 year
Anxiety
Time frame: 1 year
Depression
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoprolol and Normal saline in people with Breast Cancer, run by Kuopio University Hospital.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Anaesthesia (time frame: Intraoperative). The study lists 7 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 22 Mar 2018.