Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy

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.

Inclusion Criteria:

1. Patients must have age greater or equal to 18

2. Patients with histologic diagnosis of cervical, endometrial, or ovarian cancer who
are receiving chemotherapy

3. Any clinical stage allowed

4. GOG performance status 0, 1, or 2

5. Written informed consent and HIPAA authorization obtained prior to any initiation of
study procedures

Exclusion Criteria:

1. 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)

2. Patients who have received chronic or pulsed steroids within the past 9 months.

3. Patients with previous diagnosis of adrenal suppression.

4. Underlying psychiatric condition which would, in the opinion of the investigator,
preclude compliance with study requirements

5. Women who are pregnant are not eligible to participate.

6. 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.

7. 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.