Haelan and Nutrition in Cancer Patients

NCT00558558 | Terminated Phase 2 Results

• 1 other identifier: 2005-0370
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia; Weight Loss; Cachexia

Keywords

Solid Tumors; Cancer-Associated Anorexia; Weight Loss; Haelan; Fermented Soy Product; Nutrition; Cachexia

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)

  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.

  Baseline and Week 4 +/- 5 days

Study Arms (1)

Fermented Soy Supplement

OTHER

4 oz Haelan orally twice daily for 8 weeks

Drug: Haelan

Interventions

Haelan DRUG

4 oz orally twice daily for 8 Weeks

Also known as: Fermented Soy Supplement

Fermented Soy Supplement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Haelan Products, Inc.: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Anorexia; Weight Loss; Cachexia

Interventions

Flurandrenolone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Thinness

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Ying Guo, MD - Associate Professor
• Organization: UT MD Anderson Cancer Center

jaallo@mdanderson.org

713-745-2327

Study Officials

• Ying Guo, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 15, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 13, 2016
• Results First Posted: October 12, 2011

Record last verified: 2011-09

Locations

US (1)