Breast CancerPhase 2NCT02234466
Preoperative Oral Dexamethasone to Improve Recovery After Surgery
A Phase 2 study testing Oral dexamethasone, Ondansetron and Gelatin capsule in people with Breast Cancer, run by University of Manitoba at 1 site in Canada.
Trial summary
Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The investigators will also look at the effect of our intervention on post operative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oral dexamethasone, Ondansetron and Gelatin capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Jun 2015
- Phase
- Phase 2
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 to 80 years of age) undergoing general anesthesia for elective breast surgery (lumpectomy or mastectomy) and providing informed consent.
- American Society of Anesthesia (ASA) class I, II, \& III patients
Who cannot join
- ASA class IV and V patients
- Pregnancy
- Diabetes
- History of allergy to any study medications
- Use of steroids or anti emetics within 1 month of surgery
- Chronic pain requiring opioid treatment
Show all 9Show fewer
- History of alcohol or drug abuse (including smoking tobacco)
- Severe renal impairment (i.e. serum creatinine more than 160 umol/L)
- Poor English comprehension or psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery
Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The investigators will also look at the effect of our intervention on post operative nausea and vomiting.
Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will also complete a Clinically significant nausea and vomiting score upon discharge from the post anesthesia recovery room, repeated at 24 hours post op.
Read the detailed description
Design: This will be a single centre randomized, double blind, parallel-group, intention to treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone or placebo
Group 1: Pre-operative oral dexamethasone (10mg-2 hours pre-induction) Group 2: Placebo Sample Size: 80 patients (80% power to detect a difference of 10 points in our primary endpoint)
Study duration: 8 months
Primary endpoint: Quality of recovery at 24 hours post operation, as measured on the QoR-40 Secondary endpoints: Clinically significant nausea and vomiting on discharge from Post-Anesthesia Recovery Room (PARR) and at 24 hours.
Study hypotheses:Pre-operative oral dexamethasone will improve patient quality of recovery compared to placebo.
Secondary hypothesis: Pre-operative dexamethasone will decrease clinically significant post operative nausea and vomiting in the post anesthesia recovery room and this benefit will endure at 24 hours.
Importance: Small studies in other adult populations suggest that IV dexamethasone may improve quality of recovery. IV dexamethasone is widely used off label for postoperative nausea and vomiting (PONV) prophylaxis, oral dexamethasone has not been studied for this indication but based on the pharmacodynamics of dexamethasone, and that modulation of nucleolar transcription is likely important in dexamethasone's clinical effect; an earlier administration time is likely of benefit, this could be facilitated by an oral (vs IV) route of administration. This study will provide the preliminary support (or absence of support) for a routine, inexpensive intervention to optimize patient outcome.
Background: Single, low dose perioperative dexamethasone is safe and beneficial but common timing of administration does not maximize effectiveness. IV dexamethasone improves quality of recovery in patients undergoing laparoscopic cholecystectomy and provides a potential 1.5 mm improvement in VAS pain scores in the first 6 hours post mastectomy, which is of questionable clinical significance. A study to determine if dexamethasone improves the quality of recovery in patients undergoing breast surgery is needed in order to provide evidence for change of practices and pre-operative oral dexamethasone offers the potential for routine, low cost administration without uncomfortable side effects.
Methods: Patients will be recruited pre-operatively and contacted by telephone for preliminary consent. They will receive consent documents on the morning of surgery and be randomized at that time, they will complete a pre-operative QOR-40 and receive oral dexamethasone or placebo. During their general anaesthesia (GA) they will all receive IV Ondansetron and have their blood glucose measured 2 hours after skin incision. On discharge from PARR they will have a clinically significant nausea and vomiting scale score recorded, repeated at 24 hours post op. They will also complete the QOR-40 at 24 hours post op.
Analysis: Data will be analyzed using analysis of variance, mixed models and t-tests.
Potential Pitfalls: As the QOR-40 instrument is a survey, it is prone to inter and intra patient variability. The investigators are controlling for inter-patient variability by having patients complete the instrument before surgery to collect an individual baseline. The investigators are relying on a 25% recruitment rate of eligible patients in order to complete the study in the stated timeframe. The study has an important but narrow focus, it is not feasible to perform subgroup analysis on the small study size.
- Conditions
- Breast Cancer
- Being tested
- Oral dexamethasone, Ondansetron, Gelatin capsule
- Keywords
- Quality of Recovery (QOR40), Breast Surgery, Clinically significant Nausea and Vomiting, Postoperative Nausea and Vomiting
- Medical subject headings
- Breast Neoplasms, Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dexamethasoneDrug
Also called Decadron
Patients will received their study drug ( or placebo) 2 hours pre-induction. Allowing for the shifting schedules of the OR with the possibility of the previous case finishing early or late, the allowable range is 90-200 minutes pre-induction.
OndansetronDrug
Also called Zofran
Patients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting.
Gelatin capsuleOther
Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule
| Study group | Role | What they receive |
|---|---|---|
| Oral Dexamethasone | Active comparator | Oral dexamethasone- two 4mg tabs and one 2mg tab contained within a gelatin capsule Administered a single time, 2 hours pre-induction
Ondansetron 6mg IV will be administered at skin closure Receives: Drug: Oral dexamethasone; Drug: Ondansetron; Other: Gelatin capsule |
| Gelatin pill | Placebo comparator | Gelatin capsule contained within second gelatin capsule. Administered a single time, 2 hours pre-induction
Ondansetron 6mg IV will be administered at skin closure Receives: Drug: Ondansetron; Other: Gelatin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Quality of recovery at Post operative day 1 (POD1)
Quality of recovery as assessed by the QOR-40 will be assessed at POD1, with a baseline measure having been collected immediately pre-operatively.
Measured: 24 hours
Secondary outcomes (2)
Post operative Nausea and Vomiting immediately post operatively
Assayed by the Clinically Significant Nausea and Vomiting Scale
Measured: At discharge from Post Anesthesia Recovery Room, usually within 90 mins to 180 mins after surgery
Post operative Nausea and Vomiting in first 24 hours
Post operative Nausea and Vomiting as assessed by the Clinically Significant Nausea and Vomiting scale on POD1, assessing the period from surgery until the assessment (not excluding post anesthesia recovery room)
Measured: The first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (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.
- More trials run by University of ManitobaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Faisal Siddiqui, University of Manitoba
- Investigators
- Faisal Siddiqui, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234466
- Sponsor's protocol ID
- B2014:004
- Status last verified
- Sep 2014
- First submitted
- 31 Aug 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery
- ClinicalTrials.gov ID
- NCT02234466
- Acronym / sponsor ID
- B2014:004
- Conditions
- Breast Cancer
- Keywords
- Quality of Recovery (QOR40), Breast Surgery, Clinically significant Nausea and Vomiting, Postoperative Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 9 Sep 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.
Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The investigators will also look at the effect of our intervention on post operative nausea and vomiting.
Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will also complete a Clinically significant nausea and vomiting score upon discharge from the post anesthesia recovery room, repeated at 24 hours post op.
Detailed description
Design: This will be a single centre randomized, double blind, parallel-group, intention to treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone or placebo
Group 1: Pre-operative oral dexamethasone (10mg-2 hours pre-induction) Group 2: Placebo Sample Size: 80 patients (80% power to detect a difference of 10 points in our primary endpoint)
Study duration: 8 months
Primary endpoint: Quality of recovery at 24 hours post operation, as measured on the QoR-40 Secondary endpoints: Clinically significant nausea and vomiting on discharge from Post-Anesthesia Recovery Room (PARR) and at 24 hours.
Study hypotheses:Pre-operative oral dexamethasone will improve patient quality of recovery compared to placebo.
Secondary hypothesis: Pre-operative dexamethasone will decrease clinically significant post operative nausea and vomiting in the post anesthesia recovery room and this benefit will endure at 24 hours.
Importance: Small studies in other adult populations suggest that IV dexamethasone may improve quality of recovery. IV dexamethasone is widely used off label for postoperative nausea and vomiting (PONV) prophylaxis, oral dexamethasone has not been studied for this indication but based on the pharmacodynamics of dexamethasone, and that modulation of nucleolar transcription is likely important in dexamethasone's clinical effect; an earlier administration time is likely of benefit, this could be facilitated by an oral (vs IV) route of administration. This study will provide the preliminary support (or absence of support) for a routine, inexpensive intervention to optimize patient outcome.
Background: Single, low dose perioperative dexamethasone is safe and beneficial but common timing of administration does not maximize effectiveness. IV dexamethasone improves quality of recovery in patients undergoing laparoscopic cholecystectomy and provides a potential 1.5 mm improvement in VAS pain scores in the first 6 hours post mastectomy, which is of questionable clinical significance. A study to determine if dexamethasone improves the quality of recovery in patients undergoing breast surgery is needed in order to provide evidence for change of practices and pre-operative oral dexamethasone offers the potential for routine, low cost administration without uncomfortable side effects.
Methods: Patients will be recruited pre-operatively and contacted by telephone for preliminary consent. They will receive consent documents on the morning of surgery and be randomized at that time, they will complete a pre-operative QOR-40 and receive oral dexamethasone or placebo. During their general anaesthesia (GA) they will all receive IV Ondansetron and have their blood glucose measured 2 hours after skin incision. On discharge from PARR they will have a clinically significant nausea and vomiting scale score recorded, repeated at 24 hours post op. They will also complete the QOR-40 at 24 hours post op.
Analysis: Data will be analyzed using analysis of variance, mixed models and t-tests.
Potential Pitfalls: As the QOR-40 instrument is a survey, it is prone to inter and intra patient variability. The investigators are controlling for inter-patient variability by having patients complete the instrument before surgery to collect an individual baseline. The investigators are relying on a 25% recruitment rate of eligible patients in order to complete the study in the stated timeframe. The study has an important but narrow focus, it is not feasible to perform subgroup analysis on the small study size.
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 |
|---|---|---|
| Oral Dexamethasone | Active comparator | Drug: Oral dexamethasone, Drug: Ondansetron, Other: Gelatin capsuleOral dexamethasone- two 4mg tabs and one 2mg tab contained within a gelatin capsule Administered a single time, 2 hours pre-induction Ondansetron 6mg IV will be administered at skin closure |
| Gelatin pill | Placebo comparator | Drug: Ondansetron, Other: Gelatin capsuleGelatin capsule contained within second gelatin capsule. Administered a single time, 2 hours pre-induction Ondansetron 6mg IV will be administered at skin closure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (18 to 80 years of age) undergoing general anesthesia for elective breast surgery (lumpectomy or mastectomy) and providing informed consent.
- American Society of Anesthesia (ASA) class I, II, \& III patients
Key exclusion criteria (9 listed)
- ASA class IV and V patients
- Pregnancy
- Diabetes
- History of allergy to any study medications
- Use of steroids or anti emetics within 1 month of surgery
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 |
|---|---|---|
| Oral dexamethasoneAlso: DecadronPatients will received their study drug ( or placebo) 2 hours pre-induction. Allowing for the shifting schedules of the OR with the possibility of the previous case finishing early or late, the allowable range is 90-200 minutes pre-induction. | Drug | Oral Dexamethasone |
| OndansetronAlso: ZofranPatients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting. | Drug | Gelatin pill, Oral Dexamethasone |
| Gelatin capsuleGelatin capsule enclosing either dexamethasone tabs or second gelatin capsule | Other | Gelatin pill, Oral Dexamethasone |
Primary outcome
Change from baseline in Quality of recovery at Post operative day 1 (POD1)
Time frame: 24 hours
Quality of recovery as assessed by the QOR-40 will be assessed at POD1, with a baseline measure having been collected immediately pre-operatively.
2 secondary outcomes
Post operative Nausea and Vomiting immediately post operatively
Time frame: At discharge from Post Anesthesia Recovery Room, usually within 90 mins to 180 mins after surgery
Post operative Nausea and Vomiting in first 24 hours
Time frame: The first 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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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.
Faisal Siddiqui, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral dexamethasone, Ondansetron and Gelatin capsule in people with Breast Cancer, run by University of Manitoba at 1 site in Canada.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Sep 2014. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change from baseline in Quality of recovery at Post operative day 1 (POD1) (time frame: 24 hours). 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 Sep 2014.