Haelan and Nutrition in Cancer Patients

Stopped early · Phase 2

Conditions studied: Anorexia, Weight Loss, Cachexia

In brief

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.

Key facts

Study ID

NCT00558558

Run by

M.D. Anderson Cancer Center

People needed

6

Starts

2007-10-01

Expected to finish

2009-08-01

Last updated by the study team

2016-05-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Allergic to soy.
• 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).
• Weight less than 80 lb.
• Patient who could not tolerate oral intake of 2 Oz. of Haelan during the taste test.
• Diagnosed of breast cancer.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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