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


N/A
18 Years
N/A
Open (Enrolling)
Female
Adrenal Suppression

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Monique A Spillman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado Denver Anschutz Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10-0190

NCT ID:

NCT01209507

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Adrenal Suppression
  • Adrenal suppression
  • Chemotherapy fatigue
  • Quality of life
  • Vision, Low

Name

Location

University of Colorado Denver Anschutz Medical CampusAurora, Colorado  80045