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NCT00558558 · ClinicalTrials.gov registry record · Phase 2
Haelan and Nutrition in Cancer Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00558558: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00558558 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00558558, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DRUG Haelan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00558558
The ClinicalTrials.gov registry entry for NCT00558558 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Haelan is the first listed.
NCT00558558 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00558558 about?
NCT00558558 is a clinical study titled "Haelan and Nutrition in Cancer Patients". 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 naus...
What is the current status of trial NCT00558558?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-10. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00558558?
The interventions under investigation include: Haelan (DRUG).
Who is sponsoring clinical trial NCT00558558?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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