Haelan and Nutrition in Cancer Patients

This study has been terminated.

( Study terminated due to low recruitment. )

Study NCT00558558 Information provided by M.D. Anderson Cancer Center

First Received on November 13, 2007. Last Updated on September 2, 2011 History of Changes

Results First Received: September 2, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Anorexia Weight Loss Cachexia
Intervention:	Dietary Supplement: Haelan

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 10/22/07 to 07/24/08. All patients recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the six patients registered, two patients were ineligible and not included in any group assignment. Four patients were not eligible for analysis.

Reporting Groups

	Description
Fermented Soy Supplement	4 oz Haelan orally twice daily for 8 weeks

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Fermented Soy Supplement	4 oz Haelan orally twice daily for 8 weeks

Baseline Measures

	Fermented Soy Supplement
Number of Participants [units: participants]	6
Age [units: years] Mean ( Full Range )	59 ( 50 to 61 )
Gender [units: participants]
Female	3
Male	3
Region of Enrollment [units: participants]
United States	6

Outcome Measures

1. Primary:

Decreases in Severity of Poor Appetite [ Time Frame: 2 Years ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Ying Guo, MD - Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-2327
e-mail: jaallo@mdanderson.org

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00558558 History of Changes
Other Study ID Numbers:	2005-0370
Study First Received:	November 13, 2007
Results First Received:	September 2, 2011
Last Updated:	September 2, 2011
Health Authority:	United States: Food and Drug Administration