Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy
Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Emesis; Nausea
Intervention: Dexamethasone (Drug)
Phase: Phase 3
Sponsored by: University Health Network, Toronto
Official(s) and/or principal investigator(s):
Ian Tannock, MD PhD, Principal Investigator, Affiliation: University Health Network University of Toronto
Anna J Dodd, Phone: 4169464501, Ext: 3176, Email: firstname.lastname@example.org
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
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.
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
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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
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
Differences in nausea and vomiting by treatment period and regimen
Impact of nausea and vomiting on QOL by Functional Living Index-Emesis (FLIE) score by treatment period and regimen
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
Strength of preference for treatment cycle including dexamethasone compared to treatment cycle including placebo (Much better, Little better, No difference)
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
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
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
- (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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Patients diagnosed with breast cancer who will receive their first cycle of
non-cisplatin moderately emetogenic chemotherapy. The following regimens can be
- 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)
- 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
- Informed signed consent
- 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.
- 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
- 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
- Refusal to give informed consent.
Locations and Contacts
Anna J Dodd, Phone: 4169464501, Ext: 3176, Email: email@example.com
Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada; Recruiting
Ian Tannock, MD, Principal Investigator
Mount SinaiHospital, Toronto, Ontario M5G 2M9, Canada; Recruiting
Olivera Jugovic, Phone: 4165964200, Ext: 5333, Email: mailto:firstname.lastname@example.org
Starting date: January 2005
Last updated: January 21, 2010