Haelan and Nutrition in Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||August 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|