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Megestrol for Feeding Disorders in Children (iKanEat Trial)

Phase 4

Waitlist Available

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females aged 9 months to 9y0m at the time of consent.

Be younger than 18 years old

Must not have

Children receiving oral or inhaled steroids.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 to 14 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether megestrol can help kids with feeding tubes transition to oral feedings. 60 kids will be enrolled, half receiving megestrol and half receiving placebo.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Megestrol may cause weight gain, increased appetite, changes in mood or libido, insomnia, heart issues or blood clots. As it's used in pediatric patients transitioning from tube feeding, side effects should be closely monitored by healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 9 months and 9 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child is on oral or inhaled steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 to 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 to 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 to 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in % kilocalories/day obtained orally

Secondary study objectives

Change in child quality of life as measured by the Infant Toddler Quality of Life scale (ITQOL47)

Change in parent stress as measured by the Pediatric Inventory for Parents (PIP36)

Number of patients with adrenal insufficiency as measured by morning cortisol lab value

Side effects data

From 2013 Phase 2 trial • 31 Patients • NCT00483327

57%

Hemorrhage, GU: Vagina

30%

Weight gain

23%

Fatigue (asthenia, lethargy, malaise)

23%

Pain: Head/headache

23%

Nausea

23%

Pain: Abdomen NOS

17%

Distension/bloating, abdominal

17%

Mood alteration: Depression

13%

Gastrointestinal - Other: Increased Appetite

13%

Dyspnea (shortness of breath)

13%

Insomnia

13%

Urinary frequency/urgency

10%

Hot flashes/flushes

10%

Constipation

10%

Mood alteration: Anxiety

10%

Constitutional Symptoms - Other: thirst

10%

Neuropathy: sensory

10%

Pain: Back

Dry skin

Hypertension

Pain - Other: side of body

Pain: Chest/thorax NOS

Pain: Throat/pharynx/larynx

Sweating (diaphoresis)

Vaginal discharge (non-infectious)

Confusion

Anorexia

Glucose, serum-low (hypoglycemia)

Pain: Neuralgia/peripheral nerve

Allergic reaction/hypersensitivity (including drug fever)

Edema: head and neck:

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

Flu-like syndrome

Dysphagia (difficulty swallowing)

Hemorrhage/bleeding associated with surgery, intra-operative or postoperative

Thrombosis/thrombus/embolism

Cystitis

Diarrhea

Flatulence

Dizziness

Flushing

Hypotension

Irregular menses (change from baseline)

Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized

Dermatology/Skin - Other: skin peeling

Pain: Vagina

Urticaria (hives, welts, wheals)

Libido

Memory impairment

Musculoskeletal/Soft Tissue - Other: Spasm

Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial

Odor (patient odor)

Renal/Genitourinary - Other: Burning With Urination

Vomiting

Mood alteration: Agitation

Pruritus/itching

Pain: Pain NOS

Rigors/chills

pain: stomach

Pain: Extremity-limb

Pain: Muscle

Pain: Pleura

Proteinuria

Rash/desquamation

Rash: acne/acneiform

Dermatology/Skin - Other: blister

Pain: Pelvis

100%

80%

60%

40%

20%

Study treatment Arm

Megestrol Acetate

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MegestrolExperimental Treatment2 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: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Megestrol Acetate

2007

Completed Phase 3

~540

0 / 2Eligibility criteria met