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Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01209507
First received: September 23, 2010
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Adrenal Suppression
Other: Prevalence study only, no study intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prevalence Study of Adrenal Suppression After Adjuvant Corticosteroid Administration During Gynecologic Cancer Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Estimated Enrollment: 80
Study Start Date: September 2010
Groups/Cohorts Assigned Interventions
Chemotherapy every 3 weeks Other: Prevalence study only, no study intervention
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.
Weekly chemotherapy Other: Prevalence study only, no study intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will be open to all women over the age of 18 scheduled to begin standard of care chemotherapy for a gynecologic malignancy, either every 3 weeks (carboplatin and taxol) or weekly (cisplatin). The study is restricted by gender due to the population of interest being women with gynecologic malignancies.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209507

Contacts
Contact: Monique A Spillman, MD 303-724-2066 monique.spillman@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Monique A Spillman, MD    303-724-2066    monique.spillman@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Monique A Spillman, MD University of Colorado Denver Anschutz Medical Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01209507     History of Changes
Other Study ID Numbers: 10-0190
Study First Received: September 23, 2010
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Adrenal suppression
Chemotherapy fatigue
Quality of life

Additional relevant MeSH terms:
Vision Disorders
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014