Megestrol for Feeding Disorders in Children

(iKanEat Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether megestrol, a medication typically used to boost appetite, can help children who rely on feeding tubes transition to eating by mouth. Participants will receive either megestrol or a placebo (a dummy treatment with no active ingredients) as part of a behavioral feeding program over 24 weeks. The goal is to determine if megestrol can ease the transition away from tube feeding. Children aged 9 months to 9 years who receive most of their nutrition through a feeding tube and have feeding problems may be suitable for this trial. As a Phase 4 trial, this research examines how an already FDA-approved and effective treatment can benefit more patients, contributing to understanding its broader impact.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but children receiving oral or inhaled steroids cannot participate.

What is the safety track record for megestrol acetate and the iKanEat Behavioral Intervention?

Research has shown that megestrol is usually well-tolerated by patients. In previous studies, participants experienced only mild side effects, which are generally not serious. These may include slight changes in skin color, diarrhea, or dizziness. Serious side effects are rare. The FDA has approved megestrol for treating weight loss in certain conditions, indicating a known safety record.

Megestrol is a type of steroid and carries some risks, especially for those with kidney issues. It is mostly safe when used properly, but like any medication, monitoring for side effects and consulting a doctor if they occur is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Megestrol Acetate for feeding disorders in children because it offers a unique approach compared to standard nutritional and behavioral therapies. Unlike traditional methods, which often rely on intensive feeding interventions and support, Megestrol acts as an appetite stimulant, potentially making the weaning process from tube feeding to oral feeding smoother and more effective. Its glucocorticoid effect, although not fully understood, is believed to be key in promoting appetite and weight gain, providing a promising option for improving nutritional intake in young children.

What evidence suggests that this trial's treatments could be effective for feeding disorders in children?

Research has shown that megestrol acetate, one of the treatments in this trial, can help children gain weight. One study found that children with serious health issues who took megestrol gained more weight than those who took a placebo, a pill with no active medicine. In this trial, some participants will receive megestrol to help increase appetite and assist in transitioning from tube feeding to eating normally. Past studies have proven this treatment safe and effective for similar cases. Although the exact mechanism is unknown, it is believed to increase appetite by acting like a steroid. ^{6 7 8 9 10}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7913389/

iKanEat: protocol for a randomized controlled trial of megestrol ... Hypothesis 1. Children randomized to the megestrol group will be more successful in making the transition to oral feeding (defined as obtaining at least 90% of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24167059/

A randomized, double-blind, placebo-controlled clinical ... Conclusion: In children with high-risk malignancies, MA resulted in significant increases in mean percent weight change compared to placebo.

3. mdpi.com mdpi.com/2624-5647/5/1/8

Evaluation and Management of Pediatric Feeding Disorder Pharmacological treatment with appetite stimulants (e.g., cyproheptadine and megestrol acetate) is commonly used to improve appetite and weight ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.24828

A randomized, double‐blind, placebo‐controlled clinical ... Primary outcome was the difference between groups in mean percent weight change from beginning to end of the study period. Secondary outcomes ...

5. publications.aap.org publications.aap.org/pediatrics/article/99/3/354/67342/Megestrol-Acetate-Treatment-of-Growth-Failure-in

Megestrol Acetate Treatment of Growth Failure in Children ... In two published case series, enteral tube feeding significantly increased weight and weight:height z-scores without affecting height.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/021778s024lbl.pdf

MEGACE® ES (megestrol acetate) oral suspension Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/megestrol-oral-route/description/drg-20528334

Megestrol (oral route) - Side effects & dosage This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/021778s016lbl.pdf

Megace® ES (megestrol acetate, USP) Oral Suspension The pharmacokinetics of megestrol acetate has not been studied in specific population, for example, pediatric, renal impairment, and hepatic impairment.

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559205/

Megestrol - StatPearls - NCBI Bookshelf - NIH Generally, toxicity to megestrol is very mild, rated on a scale of Grade 0 or 1. No serious adverse drug reactions have resulted from megestrol ...

10. go.drugbank.com go.drugbank.com/drugs/DB00351

Megestrol acetate: Uses, Interactions, Mechanism of Action Megestrol acetate is a progestin that is administered orally to treat anorexia and cachexia or serious unexplained weight loss and is also used as an ...