Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
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 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.