Status:
COMPLETED
Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy
Lead Sponsor:
University of Colorado, Denver
Conditions:
Adrenal Suppression
Eligibility:
FEMALE
18+ years
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 chemo...
Detailed Description
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 req...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01209507
Start Date
February 1 2010
End Date
November 1 2015
Last Update
March 24 2017
Active Locations (1)
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1
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045