Haelan and Nutrition in Cancer Patients

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Haelan Products, Inc.
• Treatments: Flurandrenolone

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.