CancerPhase 3NCT00152867
Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy
A Phase 3 study testing Dexamethasone in people with Cancer and Emesis, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Background: Dexamethasone is a steroid, which is often given into the vein before chemotherapy to help control acute nausea and vomiting. It can also be given as an oral tablet for patients to take for the two days following chemotherapy to help minimise delayed nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2005to Sep 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with breast cancer who will receive their first cycle of non-cisplatin moderately emetogenic chemotherapy. The following regimens can be administered:
- 14-day regimens dose dense
- 21-day regimens:
- Adriamycin and Cyclophosphamide (AC) + a Taxane (T) Other regimens are eligible as long as no cisplatin or other highly emetogenic agent is part of the regimen, and a moderately emetogenic agent is included.
- Aged > 18 years
- Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale
Show all 9Show fewer
- Full recovery from any post operative sequelae
- Patients on opioids are eligible as long as their doses are stable (no change to dose in the previous week) and they have no nausea or vomiting in the 24 hours prior to the study
- Informed signed consent
Who cannot join
- Patient has previously received chemotherapy
- Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to treatment
- Nausea or vomiting in the 24 hour period prior to commencing chemotherapy
- Use of antiemetics within 24 hours of the study period
- Patient has an active infection (e.g. pneumonia) or any uncontrolled disease (e.g. diabetes, gastrointestinal obstruction), which in the opinion of the investigator might confound the results of the study or pose unwarranted risk. Patients with controlled diabetes are eligible.
- Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
Show all 18Show fewer
- Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that in the opinion of the investigator precludes study entry.
- Patient has a history of hypersensitivity or contraindication to granisetron or dexamethasone.
- Patient is taking any systemic corticosteroid therapy at any dose. Topical or inhaled steroids are permitted.
- Use of benzodiazepines in the 48 hours prior to the study period with the exception of a single dose if used for sleeping.
- Abnormal laboratory values:
- Absolute neutrophil count < 1.5 X 10^9/L
- Platelet count < 100 X 10^9/L
- Liver transaminases > 2.5 X upper limit of normal
- Bilirubin > 1.5 X upper limit of normal
- Creatinine > 1.5 X upper limit of normal
- Patients who will receive a different chemotherapy regimen in Cycle 2 than in Cycle 1. Changes in the dose of the same chemotherapy agents are permitted if required for toxicity.
- Refusal to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount SinaiHospital
Toronto, Ontario, M5G 2M9
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Randomised Double-Blind Placebo Controlled Cross Over Trial of the Impact on Quality of Life of Continuing Dexamethasone Beyond 24 Hours Following Moderately Emetogenic Chemotherapy
Background: Dexamethasone is a steroid, which is often given into the vein before chemotherapy to help control acute nausea and vomiting. It can also be given as an oral tablet for patients to take for the two days following chemotherapy to help minimise delayed nausea and vomiting. In chemotherapy regimens that cause high rates of nausea and vomiting, the use of dexamethasone is well proven. However, in chemotherapy regimens that generally cause only minimal to moderate rates of nausea and vomiting, the value of oral dexamethasone in the 48-hour period after chemotherapy is not well proven, although it is often prescribed. While dexamethasone does decrease nausea, it causes additional side-effects such as insomnia, indigestion, anxiety and mood changes. While patients with less vomiting and nausea are expected to have better quality of life (QOL), for patients with minimal nausea or vomiting, their QOL might be more affected by the side effects of the dexamethasone treatment than by the nausea.
Study Design: The study will be performed in patients who will be receiving first line chemotherapy treatment with a moderate risk of nausea/vomiting. Anti-nausea therapy for acute nausea/vomiting will be standardised and all patients will receive non-steroidal medication for delayed nausea control. Each patient will be randomly allocated to receive either oral dexamethasone or an identical appearing placebo tablet for two days after chemotherapy for the first cycle of chemotherapy, and then crossed over to the other treatment for the second cycle. Patients will complete QOL assessments, dexamethasone symptom and nausea and vomiting questionnaires, as well as nausea/vomiting diaries. This will enable the researchers to determine the effect of dexamethasone on nausea and vomiting and the impact of both the side effects of dexamethasone, and of nausea and vomiting, on QOL.
Read more
Objectives: The primary objectives are to determine patient preference for dexamethasone or placebo, and to compare changes in QOL after chemotherapy in patients who receive dexamethasone with those who receive placebo. The secondary objectives are: (1) to compare complete protection from delayed vomiting and severity of nausea; (2) to compare differences in the impact of nausea and vomiting on QOL, and (3) to compare differences in symptoms that have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between patients receiving dexamethasone and those receiving placebo.
Significance: This study will provide data to evaluate whether the benefits of dexamethasone for delayed nausea and vomiting outweigh potential side effects in patients receiving chemotherapy with a moderate risk of causing nausea and vomiting. This addresses a problem that is important to a majority of patients receiving anticancer chemotherapy. If overall QOL is improved on dexamethasone, then it should be prescribed more frequently, but if QOL is reduced on dexamethasone, and patients prefer the placebo, then its use as an anti-nausea medication for delayed nausea after moderately nauseating chemotherapy should be limited to patients with poor initial control of nausea/vomiting.
Read the detailed description
Background: Dexamethasone improves control of acute nausea and vomiting when given prior to chemotherapy, and continued administration of dexamethasone improves nausea and vomiting after highly emetogenic chemotherapy. There is no consensus about the optimal regimen for control of delayed emesis after moderately emetogenic chemotherapy but most patients receive oral dexamethasone. Many patients complain of insomnia, anxiety/agitation and indigestion whilst they are on dexamethasone, and fatigue and depressed mood after stopping it. The impact of these symptoms on patients has not been studied systematically. While patients with less vomiting and nausea are expected to have better quality of life (QOL), the QOL of patients with minimal nausea or vomiting might be more affected by the side effects of antiemetic treatment.
Hypothesis: Dexamethasone given as an antiemetic for delayed nausea and vomiting after moderately emetogenic chemotherapy reduces overall quality of life.
Research Question: Does the use of dexamethasone as a prophylactic antiemetic for delayed nausea and vomiting following moderately emetogenic chemotherapy decrease overall quality of life, as evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30).
Study Design: Using a double-blind randomised cross-over design, we will determine:
- (i) the effect of oral dexamethasone (4mg PO bid after chemotherapy) versus an identical appearing placebo on QOL of patients that receive moderately emetogenic chemotherapy, and
- (ii) patient preference for dexamethasone or placebo.
We will evaluate control of nausea and vomiting and the impact of both the side effects of dexamethasone and of nausea and vomiting on QOL. Therapy for acute emesis will be standardised (single dose intravenous granisetron and dexamethasone) and all patients will receive granisetron for delayed emetic control. Each patient will be randomly allocated to receive either dexamethasone or placebo after the first cycle of chemotherapy, and crossed over to the other arm for the second cycle. Patients will complete questionnaires that evaluate QOL, symptoms associated with dexamethasone, and nausea and vomiting at baseline and one week after their intravenous chemotherapy; they will also record symptoms in a daily diary.
The primary outcome measures are patient preference and overall QOL. The secondary objectives are: (1) to compare complete protection from delayed vomiting and severity of nausea between those receiving dexamethasone and those receiving placebo; (2) to compare differences in the impact of nausea and vomiting on QOL in those receiving dexamethasone and those receiving placebo, and (3) to compare differences in symptoms that have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between patients receiving dexamethasone and those receiving placebo.
Significance: Our study will evaluate whether the benefits of dexamethasone for delayed emetic control outweigh potential side effects in patients receiving moderately emetogenic chemotherapy. It addresses a problem that is important to the majority of patients receiving anticancer chemotherapy. If overall QOL is improved on dexamethasone, then it should be prescribed routinely. If QOL is reduced on dexamethasone, and patients prefer the placebo, then its use as an antiemetic after moderately emetogenic chemotherapy should be limited to patients who initially have poor control of emesis.
- Being tested
- Dexamethasone
- Keywords
- quality of life, dexamethasone, emesis
- Medical subject headings
- Neoplasms, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
dexamethasone 4mg PO bd for 2 days post chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dexamethasone Receives: Drug: Dexamethasone |
| 2 | Placebo comparator | Placebo Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference for the dexamethasone or the placebo arm as assessed by asking the patient whether they preferred treatment period 1 or treatment period 2
Measured: dexamethasone for one cycle of chemotherapy and placebo for one cycle
Difference in QOL as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 for chemotherapy cycles 1 and 2
Measured: dexamethasone for one cycle and placebo for one cycle
Secondary outcomes (5)
Differences in nausea and vomiting by treatment period and regimen
Measured: post period 2
Impact of nausea and vomiting on QOL by Functional Living Index-Emesis (FLIE) score by treatment period and regimen
Measured: post period 2
Symptoms and signs associated with dexamethasone use by treatment period and regimen: insomnia, indigestion/epigastric discomfort, hiccups, appetite, agitation, acne/facial rash, oral candida, depression, weight changes, blood pressure
Measured: post period 2
Strength of preference for treatment cycle including dexamethasone compared to treatment cycle including placebo (Much better, Little better, No difference)
Measured: post period 2
Proportion of patients having a clinically significant improvement in QOL (defined as an improvement in EORTC QLQ-C30 of 10 points or more) during each treatment cycle
Measured: post period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Ian Tannock, MD PhD, Principal investigator, University Health Network University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152867
- Sponsor's protocol ID
- MDJV2
- Status last verified
- Jun 2012
- First submitted
- 8 Sep 2005
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-Blind Placebo Controlled Cross Over Trial of the Impact on Quality of Life of Continuing Dexamethasone Beyond 24 Hours Following Moderately Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT00152867
- Acronym / sponsor ID
- MDJV2
- Keywords
- quality of life, dexamethasone, emesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Sep 2005 (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.
Background: Dexamethasone is a steroid, which is often given into the vein before chemotherapy to help control acute nausea and vomiting. It can also be given as an oral tablet for patients to take for the two days following chemotherapy to help minimise delayed nausea and vomiting. In chemotherapy regimens that cause high rates of nausea and vomiting, the use of dexamethasone is well proven. However, in chemotherapy regimens that generally cause only minimal to moderate rates of nausea and vomiting, the value of oral dexamethasone in the 48-hour period after chemotherapy is not well proven, although it is often prescribed. While dexamethasone does decrease nausea, it causes additional side-effects such as insomnia, indigestion, anxiety and mood changes. While patients with less vomiting and nausea are expected to have better quality of life (QOL), for patients with minimal nausea or vomiting, their QOL might be more affected by the side effects of the dexamethasone treatment than by the nausea.
Study Design: The study will be performed in patients who will be receiving first line chemotherapy treatment with a moderate risk of nausea/vomiting. Anti-nausea therapy for acute nausea/vomiting will be standardised and all patients will receive non-steroidal medication for delayed nausea control. Each patient will be randomly allocated to receive either oral dexamethasone or an identical appearing placebo tablet for two days after chemotherapy for the first cycle of chemotherapy, and then crossed over to the other treatment for the second cycle. Patients will complete QOL assessments, dexamethasone symptom and nausea and vomiting questionnaires, as well as nausea/vomiting diaries. This will enable the researchers to determine the effect of dexamethasone on nausea and vomiting and the impact of both the side effects of dexamethasone, and of nausea and vomiting, on QOL.
Objectives: The primary objectives are to determine patient preference for dexamethasone or placebo, and to compare changes in QOL after chemotherapy in patients who receive dexamethasone with those who receive placebo. The secondary objectives are: (1) to compare complete protection from delayed vomiting and severity of nausea; (2) to compare differences in the impact of nausea and vomiting on QOL, and (3) to compare differences in symptoms that have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between patients receiving dexamethasone and those receiving placebo.
Significance: This study will provide data to evaluate whether the benefits of dexamethasone for delayed nausea and vomiting outweigh potential side effects in patients receiving chemotherapy with a moderate risk of causing nausea and vomiting. This addresses a problem that is important to a majority of patients receiving anticancer chemotherapy. If overall QOL is improved on dexamethasone, then it should be prescribed more frequently, but if QOL is reduced on dexamethasone, and patients prefer the placebo, then its use as an anti-nausea medication for delayed nausea after moderately nauseating chemotherapy should be limited to patients with poor initial control of nausea/vomiting.
Detailed description
Background: Dexamethasone improves control of acute nausea and vomiting when given prior to chemotherapy, and continued administration of dexamethasone improves nausea and vomiting after highly emetogenic chemotherapy. There is no consensus about the optimal regimen for control of delayed emesis after moderately emetogenic chemotherapy but most patients receive oral dexamethasone. Many patients complain of insomnia, anxiety/agitation and indigestion whilst they are on dexamethasone, and fatigue and depressed mood after stopping it. The impact of these symptoms on patients has not been studied systematically. While patients with less vomiting and nausea are expected to have better quality of life (QOL), the QOL of patients with minimal nausea or vomiting might be more affected by the side effects of antiemetic treatment.
Hypothesis: Dexamethasone given as an antiemetic for delayed nausea and vomiting after moderately emetogenic chemotherapy reduces overall quality of life.
Research Question: Does the use of dexamethasone as a prophylactic antiemetic for delayed nausea and vomiting following moderately emetogenic chemotherapy decrease overall quality of life, as evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30).
Study Design: Using a double-blind randomised cross-over design, we will determine:
- (i) the effect of oral dexamethasone (4mg PO bid after chemotherapy) versus an identical appearing placebo on QOL of patients that receive moderately emetogenic chemotherapy, and
- (ii) patient preference for dexamethasone or placebo.
We will evaluate control of nausea and vomiting and the impact of both the side effects of dexamethasone and of nausea and vomiting on QOL. Therapy for acute emesis will be standardised (single dose intravenous granisetron and dexamethasone) and all patients will receive granisetron for delayed emetic control. Each patient will be randomly allocated to receive either dexamethasone or placebo after the first cycle of chemotherapy, and crossed over to the other arm for the second cycle. Patients will complete questionnaires that evaluate QOL, symptoms associated with dexamethasone, and nausea and vomiting at baseline and one week after their intravenous chemotherapy; they will also record symptoms in a daily diary.
The primary outcome measures are patient preference and overall QOL. The secondary objectives are: (1) to compare complete protection from delayed vomiting and severity of nausea between those receiving dexamethasone and those receiving placebo; (2) to compare differences in the impact of nausea and vomiting on QOL in those receiving dexamethasone and those receiving placebo, and (3) to compare differences in symptoms that have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between patients receiving dexamethasone and those receiving placebo.
Significance: Our study will evaluate whether the benefits of dexamethasone for delayed emetic control outweigh potential side effects in patients receiving moderately emetogenic chemotherapy. It addresses a problem that is important to the majority of patients receiving anticancer chemotherapy. If overall QOL is improved on dexamethasone, then it should be prescribed routinely. If QOL is reduced on dexamethasone, and patients prefer the placebo, then its use as an antiemetic after moderately emetogenic chemotherapy should be limited to patients who initially have poor control of emesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DexamethasoneDexamethasone |
| 2 | Placebo comparator | Drug: DexamethasonePlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with breast cancer who will receive their first cycle of non-cisplatin moderately emetogenic chemotherapy. The following regimens can be administered:
- Aged > 18 years
- Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale
- Full recovery from any post operative sequelae
- Patients on opioids are eligible as long as their doses are stable (no change to dose in the previous week) and they have no nausea or vomiting in the 24 hours prior to the study
Key exclusion criteria (18 listed)
- Patient has previously received chemotherapy
- Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to treatment
- Nausea or vomiting in the 24 hour period prior to commencing chemotherapy
- Use of antiemetics within 24 hours of the study period
- Patient has an active infection (e.g. pneumonia) or any uncontrolled disease (e.g. diabetes, gastrointestinal obstruction), which in the opinion of the investigator might confound the results of the study or pose unwarranted risk. Patients with controlled diabetes are eligible.
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 |
|---|---|---|
| Dexamethasonedexamethasone 4mg PO bd for 2 days post chemotherapy | Drug | 1, 2 |
Primary outcome
Patient preference for the dexamethasone or the placebo arm as assessed by asking the patient whether they preferred treatment period 1 or treatment period 2
Time frame: dexamethasone for one cycle of chemotherapy and placebo for one cycle
Difference in QOL as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 for chemotherapy cycles 1 and 2
Time frame: dexamethasone for one cycle and placebo for one cycle
5 secondary outcomes
Differences in nausea and vomiting by treatment period and regimen
Time frame: post period 2
Impact of nausea and vomiting on QOL by Functional Living Index-Emesis (FLIE) score by treatment period and regimen
Time frame: post period 2
Symptoms and signs associated with dexamethasone use by treatment period and regimen: insomnia, indigestion/epigastric discomfort, hiccups, appetite, agitation, acne/facial rash, oral candida, depression, weight changes, blood pressure
Time frame: post period 2
Strength of preference for treatment cycle including dexamethasone compared to treatment cycle including placebo (Much better, Little better, No difference)
Time frame: post period 2
Proportion of patients having a clinically significant improvement in QOL (defined as an improvement in EORTC QLQ-C30 of 10 points or more) during each treatment cycle
Time frame: post period 2
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 28 Jun 2012.
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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.
Ian Tannock, MD PhD principal investigator
University Health Network University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Cancer and Emesis, run by University Health Network, Toronto at 2 sites 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 9 inclusion and 18 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 28 Jun 2012. 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 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 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 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?
Patient preference for the dexamethasone or the placebo arm as assessed by asking the patient whether they preferred treatment period 1 or treatment period 2 (time frame: dexamethasone for one cycle of chemotherapy and placebo for one cycle). The study lists 2 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 28 Jun 2012.