Study Design: Using a double-blind randomised cross-over design, we will determine:. 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.
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. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. Patients diagnosed with breast cancer who will receive their first cycle of non-cisplatin moderately emetogenic chemotherapy. The following regimens can be administered:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Skip to Content. Learn more. Clinical Trials Our experts conduct clinical trials to deliver cutting-edge treatment to our patients. Find a trial. Our Experts Our team includes expert hematologists and oncologists. Meet the team. Request an Appointment Schedule an appointment by calling Contact us. Types of Cancer Programs. The exact percentages of patients that will experience dexamethasone side effects is unknown because it has been used under widely varying patient populations in a variety of clinical trials:.
Dexamethasone should be used in pregnant women only if the potential benefits to the mother outweigh the potential risks to the unborn baby. Labs blood tests may be checked to monitor for side effects of dexamethasone.
Depending upon the results, your doctor may advise to continue dexamethasone as planned or switch to an alternative therapy. Dexamethasone may increase blood sugars. If you are diabetic, you may need to adjust medications used to lower blood sugar while taking dexamethasone. A better understanding of your treatments will allow you to ask more questions of your healthcare team.
We then hope that with the answers, you will get better results and have greater satisfaction with your care. Because we know it's not always easy to know what questions to ask, we've tried to make it easy for you! Blocking these proteins, on the other hand, reversed the drug's unwanted effects on cancer cell survival.
Although the authors are not yet ready to stop using dexamethasone, a very effective drug for prevention of side effects from chemotherapy, Conzen suggests that the evidence is mounting that oncologists "should begin to study the effects of using this drug routinely as part of breast cancer therapy. We offer online appointment scheduling for video and in-person appointments for adult and pediatric primary care and many specialties.
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Care Connection Ingalls For help with Ingalls Care Connection, call us at or email portalsupport ingalls. Share with facebook Share with twitter Share with linkedin. Forefront News. Widely used anti-nausea drug may interfere with cancer chemotherapy.
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