Haelan and Nutrition in Cancer Patients
Condition: Anorexia; Weight Loss; Cachexia
MeSH terms: Wasting Syndrome; Weight Loss; Anorexia; Cachexia
Intervention: Haelan
Intervention description: 4 oz orally twice daily for 8 Weeks
Intervention MeSH terms: Flurandrenolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Healthy volunteers: No
Keywords: Solid Tumors; Cancer-Associated Anorexia; Weight Loss; Haelan; Fermented Soy Product; Nutrition; Cachexia

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.
    

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.