Overview

Haelan and Nutrition in Cancer Patients

Status:
Terminated
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Haelan Products, Inc.
Treatments:
Flurandrenolone