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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00558558
Eligibility Criteria:
Inclusion Criteria:
1. Anorexia (defined as \> 30mm on a visual analog scale \[VAS\] of 0 to 100mm)
2. Weight loss (defined as weight loss \> 5% within last 6 months)
3. Normal cognition (per treating physician's opinion)
4. Written informed consent
5. Advanced solid tumor (defined as locally recurrent or metastatic disease)
6. Patient must have perceived weight loss as a problem.
7. Able to maintain oral food intake within one week prior to enrollment in this study.
Exclusion Criteria:
1. Evidence of ascites (per treating physician's opinion).
2. Receiving supplementary tube feedings or parenteral nutrition
3. Known mechanical obstruction of the alimentary tract, or intractable vomiting
4. Add or change dose of the following medication within 2 weeks prior to this trial or during this trial: megestrol, corticosteroid, mirtazapine, metoclopramide and dronabinol, with the exception of pre-medication for chemotherapy (10-20 mg Decadron intavenous (IV) once and/or Reglan 10 mg IV x1 prior to chemotherapy).
5. Allergic to soy.
6. Positive pregnancy test for female patients of child-bearing potential. (Definition of child-bearing potential: not post-menopausal for past 12 months or nor surgically sterile)
7. Female patients with child bearing potential, but refuse to practice accepted methods of contraception (acceptable forms of contraception include: continuous abstinence, Depo-Provera shot, tubal ligation, NuvaRing vaginal ring, Ortho Evra skin patch, oral contraceptive, IUD-Mirena, vasectomy, male condom, diaphragm).
8. Weight less than 80 lb.
9. Patient who could not tolerate oral intake of 2 Oz. of Haelan during the taste test.
10. Diagnosed of breast cancer.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00558558
Study Brief:
Protocol Section:
NCT00558558