Haelan and Nutrition in Cancer Patients
|ClinicalTrials.gov Identifier: NCT00558558|
Recruitment Status : Terminated (Study terminated due to low recruitment.)
First Posted : November 15, 2007
Results First Posted : October 12, 2011
Last Update Posted : May 13, 2016
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Weight Loss Cachexia||Drug: Haelan||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Examining the Role of Fermented Soy Beverage for Improving Cancer-Associated Anorexia and Cachexia|
|Study Start Date :||October 2007|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
Fermented Soy Supplement
4 oz Haelan orally twice daily for 8 weeks
4 oz orally twice daily for 8 Weeks
Other Name: Fermented Soy Supplement
- Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product) [ Time Frame: Baseline and Week 4 +/- 5 days ]Change in 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558558
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ying Guo, MD||M.D. Anderson Cancer Center|