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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT00765466
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.
* Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is permitted except for neo-adjuvant or adjuvant programs.
* Between the ages of 18-85.
* Symptoms of recurrent or metastatic cancer in which anorexia is a predominant symptom, not necessarily associated with cachexia, and are not attributed to anemia, concomitant illnesses, or obstruction or loss of organ function.
* Karnofsky performance status of 40%
* Palliative Prognostic Score (PaP) of less than 6
* Patient is expected to be able to remain on a study protocol for two months.
* Pretreatment laboratory data within 7 days of enrollment:
* Hemoglobin \>8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication.
* Absolute neutrophil count (ANC) 1,500/mm3.
* Platelets 50,000/mm3.
* Total bilirubin 2.0
* ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the ULN.
* Creatinine 1.5 mg/dL.
* Normal TSH
* Testosterone levels determined.
* Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care.
* Ability to self-administer subcutaneous medication if an assistant or nurse is not available, and to keep a compliance journal documenting injections at home.
* If on an antidepressant, the dose must have been stabilized for at least 30 days.
* Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.
* Male patient agrees to use an acceptable barrier method for contraception during the study
Exclusion Criteria:
* Patient has uncontrolled brain metastases or central nervous system disease.
* Patient has mechanical, non-reversible reason for not being able to eat, or have a potential for developing malignant bowel obstruction during the course of the induction phase of treatment, or patients requiring a PEG for obstruction.
* Patient has had any major surgery within four weeks of enrollment.
* Patient has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* In the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
* Female patient is pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT00765466
Study Brief:
Protocol Section:
NCT00765466