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Gynecologic Oncology patients have several different chemotherapy regimens, and dexamethasone is now routinely given to prevent allergic reactions to the chemotherapeutic agents. The most common chemotherapeutic agents used are paclitaxel and carboplatin. This combination regimen is given every three weeks for a total of 5-6 doses. Each dose is given after administration of 20 mg dexamethasone twelve hours prior to and the morning of chemotherapy. Dexamethasone is used for its antiemetic effects, but also to minimize the potentially fatal hypersensitivity reaction that can occur with paclitaxel. Another commonly used chemotherapy regimens is weekly cisplatin given with one dose of dexamethasone for cervical cancer. Chronic steroids are known to cause adrenal suppression, but it is not known if the amount of dexamethasone given with the gynecologic cancer chemotherapy regimens described above causes adrenal insufficiency in these patients. The investigators hypothesis is that some women receiving steroids with their chemotherapy may have adrenal insufficiency, and that they will have greater than normal chemotherapy-related fatigue.
This is a non-blinded, non-randomized, non-interventional prospective cohort study to evaluate the prevalence of adrenal suppression in gynecologic cancer patients undergoing chemotherapy regimens requiring concurrent dexamethasone. Women with gynecologic cancers (including cervical, endometrial, ovarian, fallopian tube, or primary peritoneal cancers) who are scheduled to begin chemotherapy with any of the standard chemotherapy regimens that also receive dexamethasone. After informed consent is obtained, they will have peripheral blood samples drawn at the time of routine blood draw for (ideally a fasting morning) cortisol level at three different times in their routine care. Patients will also answer a quality of life questionnaire at the times of these blood draws to assess for symptoms associated with treatment (nausea, vomiting, fatigue). A total of 80 subjects will be recruited to participate. 40 subjects will be given chemotherapy regimens receiving dexamethasone with three chemotherapy treatments in a three week cycle. 40 subjects will be given chemotherapy regimens receiving dexamethasone with one chemotherapy treatment in a three week cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy every 3 weeks | One treatment of chemotherapy every 3 weeks. Chemotherapy will either be 2 doses of 20 mg orally (PO) (12 hrs prior and immediately before treatment) or 1 dose via IV. The total dose per cycle is 20-40 mg every 3 weeks for 18 weeks. |
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| Weekly chemotherapy | Chemotherapy will be given three times in a three week cycle. Chemotherapy will be given either Day 1, 8, and day 15 or Day 1,2 and day 8). Chemotherapy will either be 2 doses of 20 mg PO (12 hrs priors and immediately before treatment) or 1 dose via IV. The total dose per cycle will be 20-40 mg approximately for 18 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Other | This study is designed only to look at the prevalence of adrenal suppression during chemotherapy. If adrenal suppression is detected, treatment will be off-study at the treating physician's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the level of adrenal suppression with recurrent, intermittent steroid administration during gynecologic chemotherapy regimens in all participating patients | This will be done by testing a morning cortisol level in patients at the time of routine blood draw at three different time points in each patient's chemotherapy regimen. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the differences in quality of life scores among patients with adrenal suppression and those with normal function | Differences in quality of life scores will be measured using a modified FACT-G questionnaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be open to all women over the age of 18 scheduled to begin standard of care chemotherapy for a gynecologic malignancy, either every 3 weeks (carboplatin and taxol) or weekly (cisplatin). The study is restricted by gender due to the population of interest being women with gynecologic malignancies.
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| Name | Affiliation | Role |
|---|---|---|
| Monique A Spillman, MD | University of Colorado Denver Anschutz Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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