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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). 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.
Primary Outcome
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.
Interventions
- DRUG Haelan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
Why NCT00558558 stopped before completion
NCT00558558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Haelan is the first listed.
NCT00558558 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00558558's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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