Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy

NCT01209507 | Completed

• 1 other identifier: 10-0190.cc
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adrenal Suppression

Keywords

Adrenal suppression; Chemotherapy fatigue; Quality of life

Outcome Measures

Primary Outcomes (1)

• Identify the level of adrenal suppression with recurrent, intermittent steroid administration during gynecologic chemotherapy regimens in all participating patients

  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.

  6 months

Secondary Outcomes (1)

• Identify the differences in quality of life scores among patients with adrenal suppression and those with normal function

  6 months

Study Arms (2)

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.

Other: Chemotherapy

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.

Other: Chemotherapy

Interventions

Chemotherapy OTHER

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.

Also known as: Adrenal Suppression

Chemotherapy every 3 weeks; Weekly chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Monique A Spillman, MD

  University of Colorado Denver Anschutz Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 27, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)