Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy

Completed

Conditions studied: Adrenal Suppression

In brief

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.

Key facts

Study ID

NCT01209507

Run by

University of Colorado, Denver

People needed

19

Starts

2010-02-01

Expected to finish

2015-11-01

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have age greater or equal to 18
• Patients with histologic diagnosis of cervical, endometrial, or ovarian cancer who are receiving chemotherapy
• Any clinical stage allowed
• GOG performance status 0, 1, or 2
• Written informed consent and HIPAA authorization obtained prior to any initiation of study procedures

You may not qualify if…

• The presence of other comorbid conditions known to impact adrenal function, whether primary adrenal dysfunction, or dysfunction due to administration of steroids for treatment (Addison's or Cushings disease, pituitary or hypothalamic disease, systemic lupus erythematosis, rheumatoid arthritis, asthma)
• Patients who have received chronic or pulsed steroids within the past 9 months.
• Patients with previous diagnosis of adrenal suppression.
• Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
• Women who are pregnant are not eligible to participate.
• Patients who have received prior radiotherapy or chemotherapy for an abdominal or pelvic tumor are excluded. Prior radiation or adjuvant chemotherapy for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients with invasive malignancies, with exception of non-melanoma skin cancer, and specific malignancies noted above, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol are excluded.

Where it is running

• University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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