Adrenal SuppressionNCT01209507
Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy
An observational study of Adrenal Suppression, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adrenal Suppression
- What is being tested?
- Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: A Prevalence Study of Adrenal Suppression After Adjuvant Corticosteroid Administration During Gynecologic Cancer 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 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.
Read the detailed description
This is a non-blinded, non-randomized, non-interventional prospective cohort study to evaluate the prevalence of adrenal suppression in gynecologic cancer patients undergoing chemotherapy regimens requiring concurrent dexamethasone. Women with gynecologic cancers (including cervical, endometrial, ovarian, fallopian tube, or primary peritoneal cancers) who are scheduled to begin chemotherapy with any of the standard chemotherapy regimens that also receive dexamethasone. After informed consent is obtained, they will have peripheral blood samples drawn at the time of routine blood draw for (ideally a fasting morning) cortisol level at three different times in their routine care. Patients will also answer a quality of life questionnaire at the times of these blood draws to assess for symptoms associated with treatment (nausea, vomiting, fatigue). A total of 80 subjects will be recruited to participate. 40 subjects will be given chemotherapy regimens receiving dexamethasone with three chemotherapy treatments in a three week cycle. 40 subjects will be given chemotherapy regimens receiving dexamethasone with one chemotherapy treatment in a three week cycle.
- Conditions
- Adrenal Suppression
- Being tested
- Chemotherapy
- Keywords
- Adrenal suppression, Chemotherapy fatigue, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyOther
Also called Adrenal Suppression
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Identify the differences in quality of life scores among patients with adrenal suppression and those with normal function
Differences in quality of life scores will be measured using a modified FACT-G questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal SuppressionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monique A Spillman, MD, Principal investigator, University of Colorado Denver Anschutz Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209507
- Sponsor's protocol ID
- 10-0190.cc
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2010
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prevalence Study of Adrenal Suppression After Adjuvant Corticosteroid Administration During Gynecologic Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT01209507
- Acronym / sponsor ID
- 10-0190.cc
- Conditions
- Adrenal Suppression
- Keywords
- Adrenal suppression, Chemotherapy fatigue, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-blinded, non-randomized, non-interventional prospective cohort study to evaluate the prevalence of adrenal suppression in gynecologic cancer patients undergoing chemotherapy regimens requiring concurrent dexamethasone. Women with gynecologic cancers (including cervical, endometrial, ovarian, fallopian tube, or primary peritoneal cancers) who are scheduled to begin chemotherapy with any of the standard chemotherapy regimens that also receive dexamethasone. After informed consent is obtained, they will have peripheral blood samples drawn at the time of routine blood draw for (ideally a fasting morning) cortisol level at three different times in their routine care. Patients will also answer a quality of life questionnaire at the times of these blood draws to assess for symptoms associated with treatment (nausea, vomiting, fatigue). A total of 80 subjects will be recruited to participate. 40 subjects will be given chemotherapy regimens receiving dexamethasone with three chemotherapy treatments in a three week cycle. 40 subjects will be given chemotherapy regimens receiving dexamethasone with one chemotherapy treatment in a three week cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy every 3 weeks | – | Other: ChemotherapyOne 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. |
| Weekly chemotherapy | – | Other: ChemotherapyChemotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: Adrenal SuppressionThis 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 | Chemotherapy every 3 weeks, Weekly chemotherapy |
Primary outcome
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.
1 secondary outcome
Identify the differences in quality of life scores among patients with adrenal suppression and those with normal function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Adrenal Suppression
RecruitingObservational study
A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children
Adrenal Insufficiency, Leukemia, Lymphoblastic, Acute, Pediatric
Not yet recruitingPhase 4
Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
Secondary Adrenal Insufficiency, Hypotension
RecruitingPhase 2
NeSST2: The Development of a Noninvasive Short Synacthen Test
Adrenal Suppression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique A Spillman, MD principal investigator
University of Colorado Denver Anschutz Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Suppression, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the level of adrenal suppression with recurrent, intermittent steroid administration during gynecologic chemotherapy regimens in all participating patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.