Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy
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ClinicalTrials.gov Identifier: NCT01209507 |
Recruitment Status
:
Completed
First Posted
: September 27, 2010
Last Update Posted
: March 24, 2017
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Condition or disease | Intervention/treatment |
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Adrenal Suppression | Other: Chemotherapy |
Study Type : | Observational |
Actual Enrollment : | 19 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prevalence Study of Adrenal Suppression After Adjuvant Corticosteroid Administration During Gynecologic Cancer Chemotherapy |
Actual Study Start Date : | February 2010 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Chemotherapy every 3 weeks
One treatment of chemotherapy every 3 weeks. Chemotherapy will either be 2 doses of 20 mg orally (PO) (12 hrs prior and immediately before treatment) or 1 dose via IV. The total dose per cycle is 20-40 mg every 3 weeks for 18 weeks.
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Other: Chemotherapy
This study is designed only to look at the prevalence of adrenal suppression during chemotherapy. If adrenal suppression is detected, treatment will be off-study at the treating physician's discretion.
Other Name: Adrenal Suppression
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Weekly chemotherapy
Chemotherapy will be given three times in a three week cycle. Chemotherapy will be given either Day 1, 8, and day 15 or Day 1,2 and day 8). Chemotherapy will either be 2 doses of 20 mg PO (12 hrs priors and immediately before treatment) or 1 dose via IV. The total dose per cycle will be 20-40 mg approximately for 18 weeks.
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Other: Chemotherapy
This study is designed only to look at the prevalence of adrenal suppression during chemotherapy. If adrenal suppression is detected, treatment will be off-study at the treating physician's discretion.
Other Name: Adrenal Suppression
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- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209507
United States, Colorado | |
University of Colorado Denver Anschutz Medical Campus | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Monique A Spillman, MD | University of Colorado Denver Anschutz Medical Center |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01209507 History of Changes |
Other Study ID Numbers: |
10-0190.cc |
First Posted: | September 27, 2010 Key Record Dates |
Last Update Posted: | March 24, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by University of Colorado, Denver:
Adrenal suppression Chemotherapy fatigue Quality of life |
Additional relevant MeSH terms:
Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Eye Diseases Signs and Symptoms Epinephrine Racepinephrine Epinephryl borate Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents |