Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152867
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2005-09-08
Brief Title:
Dexamethasone Study Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 nauseavomiting Anti-nausea therapy for acute nauseavomiting 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 nauseavomiting 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 nauseavomiting
Study Design The study will be performed in patients who will be receiving first line chemotherapy treatment with a moderate risk of nauseavomiting Anti-nausea therapy for acute nauseavomiting 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 nauseavomiting 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 nauseavomiting
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 anxietyagitation 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None