Clinical Trial: Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Prevalence Study of Adrenal Suppression After Adjuvant Corticosteroid Administration During Gynecologic Cancer Chemotherapy

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Colorado, Denver

Current Primary Outcome: Identify the level of adrenal suppression with recurrent, intermittent steroid administration during gynecologic chemotherapy regimens in all participating patients [ Time Frame: 6 months ]

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.


Original Primary Outcome:

Current Secondary Outcome: Identify the differences in quality of life scores among patients with adrenal suppression and those with normal function [ Time Frame: 6 months ]

Differences in quality of life scores will be measured using a modified FACT-G questionnaire


Original Secondary Outcome:

Information By: University of Colorado, Denver

Dates:
Date Received: September 23, 2010
Date Started: February 2010
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017