Haelan and Nutrition in Cancer Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Haelan Products, Inc.
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00558558

Purpose

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.

Condition	Intervention	Phase
Anorexia Weight Loss Cachexia	Dietary Supplement: Haelan	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Examining the Role of Fermented Soy Beverage for Improving Cancer-Associated Anorexia and Cachexia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Weight Control

Drug Information available for: Flurandrenolone

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Decreases in Severity of Poor Appetite [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Determination of treatment with Haelan (fermented soy product) ability to decrease 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.

Enrollment:	6
Study Start Date:	October 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fermented Soy Supplement 4 oz Haelan orally twice daily for 8 weeks	Dietary Supplement: Haelan 4 oz orally twice daily for 8 Weeks Other Name: Fermented Soy Supplement

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558558

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Haelan Products, Inc.

Investigators

Principal Investigator:

Ying Guo, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

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

Keywords provided by M.D. Anderson Cancer Center:

Solid Tumors
Cancer-Associated Anorexia
Weight Loss
Haelan

Fermented Soy Product
Nutrition
Cachexia

Additional relevant MeSH terms:

Anorexia
Cachexia
Weight Loss
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Body Weight Changes
Body Weight

Flurandrenolone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012