Haelan and Nutrition in Cancer Patients

This study has been terminated.
(Study terminated due to low recruitment.)
Sponsor:
Collaborator:
Haelan Products, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00558558
First received: November 13, 2007
Last updated: September 2, 2011
Last verified: September 2011
  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 2

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:


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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anorexia (defined as > 30mm on a visual analog scale [VAS] of 0 to 100mm)
  2. Weight loss (defined as weight loss > 5% within last 6 months)
  3. Normal cognition (per treating physician's opinion)
  4. Written informed consent
  5. Advanced solid tumor (defined as locally recurrent or metastatic disease)
  6. Patient must have perceived weight loss as a problem.
  7. Able to maintain oral food intake within one week prior to enrollment in this study.

Exclusion Criteria:

  1. Evidence of ascites (per treating physician's opinion).
  2. Receiving supplementary tube feedings or parenteral nutrition
  3. Known mechanical obstruction of the alimentary tract, or intractable vomiting
  4. 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).
  5. Allergic to soy.
  6. 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)
  7. 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).
  8. Weight less than 80 lb.
  9. Patient who could not tolerate oral intake of 2 Oz. of Haelan during the taste test.
  10. 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:
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 April 21, 2014