Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT00878995
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Mini Mental State Examination score \> 23
Exclusion Criteria:
* Pregnancy
* Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes
* Significant liver, renal, or heart disease
* Diabetes mellitus or other untreated endocrine disease
* Polycystic ovary syndrome and/or hyperthecosis
* Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g., Sertoli- Leydig cell tumor)
* Non-classical adrenal hyperplasia
* Cushing's syndrome
* Glucocorticoid resistance
* Hyperprolactinoma or hypothyroidism
* Lactose intolerance
* Alcohol or drug abuse
* Recent treatment (within 3 months) with anabolic steroids
* Ongoing anticoagulant therapy
* Any other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00878995
Study Brief:
Protocol Section:
NCT00878995