Prevalence Study of Adrenal Suppression After Corticosteroids During Chemotherapy
2017년 3월 23일 업데이트: University of Colorado, Denver
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
19
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Denver Anschutz Medical Campus
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
다른 이름들:
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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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Identify the level of adrenal suppression with recurrent, intermittent steroid administration during gynecologic chemotherapy regimens in all participating patients
기간: 6 months
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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.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Identify the differences in quality of life scores among patients with adrenal suppression and those with normal function
기간: 6 months
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Differences in quality of life scores will be measured using a modified FACT-G questionnaire
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Monique A Spillman, MD, University of Colorado Denver Anschutz Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2010년 2월 1일
기본 완료 (실제)
2015년 11월 1일
연구 완료 (실제)
2015년 11월 1일
연구 등록 날짜
최초 제출
2010년 9월 23일
QC 기준을 충족하는 최초 제출
2010년 9월 24일
처음 게시됨 (추정)
2010년 9월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 23일
마지막으로 확인됨
2017년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 10-0190.cc
개별 참가자 데이터(IPD) 계획
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아니요
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .