Haelan and Nutrition in Cancer Patients (NCT00558558) | Clinical Trial Compass
TerminatedPhase 2
Haelan and Nutrition in Cancer Patients
Stopped: Study terminated due to low recruitment.
United States6 participantsStarted 2007-10
Plain-language summary
Primary:
* To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
* To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
* To determine if treatment with Haelan can increase patient's calorie intake, albumin, pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence analysis), and weight at week 4+/- 5 days.
* To determine if treatment with Haelan can decrease patient's Functional assessment of anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days.
* To assess the feasibility of accrual, and adherence to the Haelan consumption.
Secondary:
* Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients.
* Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with primary outcome in these patients.
* To determine if treatment with Haelan can increase patient's functional status at week 4+/- 5 days.
Who can participate
SexALL
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Inclusion criteria
✓. Anorexia (defined as \> 30mm on a visual analog scale \[VAS\] of 0 to 100mm)
✓. Weight loss (defined as weight loss \> 5% within last 6 months)
✓. Normal cognition (per treating physician's opinion)
✓. Written informed consent
✓. Advanced solid tumor (defined as locally recurrent or metastatic disease)
✓. Patient must have perceived weight loss as a problem.
✓. Able to maintain oral food intake within one week prior to enrollment in this study.
Exclusion criteria
✕. Evidence of ascites (per treating physician's opinion).
✕. Receiving supplementary tube feedings or parenteral nutrition
✕. Known mechanical obstruction of the alimentary tract, or intractable vomiting
✕. 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).
What they're measuring
1
Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)
✕. 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)
✕. 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).