Megestrol for Feeding Disorders in Children

(iKanEat Trial)

Recruiting at 7 trial locations

Overseen By Kelsey M Dean, RD, CCRP

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Kansas Medical Center

Must not be taking: Steroids

Disqualifiers: Non-English speaking parents, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30).

Are You a Good Fit for This Trial?

The iKanEat trial is for children aged 9 months to 9 years with chronic oral food refusal who rely on tube feeding for over 80% of their daily calories. They must have the necessary oral and behavioral skills for eating, as assessed by a multidisciplinary team, and be medically stable to transition from tube to oral feeding.

Inclusion Criteria

Subjects must have a G or G/J tube.

Subjects must possess the oral motor skills necessary for eating. Subjects must possess behavioral skills necessary for mealtimes.

Subjects must have a ≥ 3 month history of feeding problems as identified by a diagnosis from a multidisciplinary feeding team, and must have permission from the physician on the team to ensure that they are medically stable enough to participate in a weaning study.

Exclusion Criteria

I am a parent with a condition that might make participating in the study hard.

Your parents do not speak English.

My child is currently receiving frequent behavioral feeding therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either megestrol or placebo as part of a 24-week behavioral feeding protocol to transition from tube to oral feedings.

24 weeks

Regular visits as per protocol

Megestrol Tapering

Megestrol is dosed at full dose weeks 10-11, at 66% dose week 12, at 33% dose week 14, and fully tapered at the end of week 14.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of child quality of life and parent stress.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iKanEat Behavioral Intervention
• Megestrol Acetate

Trial Overview This study tests if megestrol combined with a behavioral feeding protocol helps kids switch from tube to mouth feeding. It's randomized: half get megestrol, half get placebo; neither doctors nor participants know who gets which. The treatment lasts for 24 weeks across multiple centers.

How Is the Trial Designed?

Group I: Megestrol Experimental Treatment 2 Interventions

Megestrol is a steroid and progestational drug FDA approved for treating anorexia or weight loss in patients with acquired immunodeficiency syndrome. Its use in the current protocol is "off label" to stimulate appetite in tube-fed infants and toddlers who are weaning from tube feedings and learning to eat. The precise mechanism of action that leads to increased appetite and weight gain is unknown, but is probably related to megestrol's glucocorticoid effect. The proposed study will use megestrol 6 mg/kg/day in two doses because this dose has been effective and safe in two previous studies using megestrol to stimulate appetite in children transitioning from tube to oral feedings. The megestrol will be dosed at full dose weeks 10-11, at 66% dose week 12, at 33% dose week 14, and fully tapered at the end of week 14. Megestrol is absorbed from the small bowel, so feeding it through the tube will be acceptable.

Group II: Placebo Placebo Group 1 Intervention

Subjects randomized to the placebo protocol will receive a placebo syrup identical in taste and smell to megestrol at the same intervals as those in the megestrol group but the syrup will contain no active ingredients.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+