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NCT01209507 · ClinicalTrials.gov registry record

Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy

A clinical trial, sponsored by University of Colorado, Denver.

Completed
Registry status
19
Enrollment target

NCT01209507: Completed study, sponsored by University of Colorado, Denver.

NCT01209507 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01209507 has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
19 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Chemotherapy

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2010-02
Est. Completion 2015-11
University of Colorado, Denver

1,283 total trials

What the finished NCT01209507 record still lists

NCT01209507 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Chemotherapy is the first listed.

NCT01209507 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01209507 about?

NCT01209507 is a clinical study titled "Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy". 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 thre...

What is the current status of trial NCT01209507?

This trial is currently completed. The enrollment target is 19 participants. The study started on 2010-02. Estimated completion is 2015-11.

What interventions are being tested in trial NCT01209507?

The interventions under investigation include: Chemotherapy (OTHER).

Who is sponsoring clinical trial NCT01209507?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01209507, the US trial registry maintained by the National Library of Medicine. NCT01209507 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.