Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy.
Recruitment status was Recruiting
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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 |
| 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 |
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.
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01209507
| Contact: Monique A Spillman, MD | 303-724-2066 | monique.spillman@ucdenver.edu |
| 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 | |
| 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 |
ClinicalTrials.gov processed this record on March 01, 2015