Haelan and Nutrition in Cancer Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Haelan Products, Inc.
Information provided by:	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 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 FACIT-F and FAACT 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 Control: Uncontrolled 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 Fatigue 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:

To find out if a fermented soy product called Haelan can slow weight loss, improve poor appetite, decrease fatigue, and increase energy. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To find out how well the soy product is tolerated. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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 x 8 weeks	Dietary Supplement: Haelan 4 oz orally twice daily x 8 Weeks

Show Detailed Description

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 IV x 1 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:	U.T. M.D. Anderson Cancer Ceter ( Ying Guo, MD/Associate Professor )
Study ID Numbers:	2005-0370
Study First Received:	November 13, 2007
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00558558 History of Changes
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:

Anti-Inflammatory Agents
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cachexia
Emaciation
Hormones
Glucocorticoids

Pharmacologic Actions
Body Weight
Signs and Symptoms
Therapeutic Uses
Weight Loss
Anorexia
Body Weight Changes
Flurandrenolone

ClinicalTrials.gov processed this record on March 18, 2010