Trial Outcomes & Findings for Haelan and Nutrition in Cancer Patients (NCT NCT00558558)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Baseline and Week 4 +/- 5 days

Results posted on

2016-05-13

Recruitment Period: 10/22/07 to 07/24/08. All patients recruited at UT MD Anderson Cancer Center.

Of the six patients registered, two patients were ineligible and not included in any group assignment. Four patients were not eligible for analysis.

Participant milestones
Measure	Fermented Soy Supplement 4 oz Haelan orally twice daily for 8 weeks
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Fermented Soy Supplement 4 oz Haelan orally twice daily for 8 weeks
Overall Study Unable to swallow	1
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	4

Haelan and Nutrition in Cancer Patients

Baseline characteristics by cohort
Measure	Fermented Soy Supplement n=6 Participants 4 oz Haelan orally twice daily for 8 weeks
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

Timeframe: Baseline and Week 4 +/- 5 days

Population: The participants were not eligible for analysis based on the primary outcome timeline.

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.

Outcome data not reported

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Fermented Soy Supplement n=4 participants at risk 4 oz Haelan orally twice daily for 8 weeks
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Number of events 1 • 17 months

Adverse event data not reported

UT MD Anderson Cancer Center

Phone: 713-745-2327