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Megestrol for Feeding Disorders in Children (iKanEat Trial)

Q: How can I participate in this clinical experiment?

This experiment will involve 60 subjects between the ages of 9 months and 8 years old that are currently diagnosed with an <a href="https://www.withpower.com/clinical-trials/eating-disorder">eating disorder</a>. In addition to this, they must have a G or G/J tube in place, adequate oral motor skills for consuming food, and behavioral capacity necessary for mealtime routines.

Q: Has the United States Food and Drug Administration sanctioned Megestrol Acetate?

According to our assessment, Megestrol Acetate has been granted a safety score of 3 due to it being approved by the FDA in Phase 4 clinical trials.

Q: Have there been antecedent experiments utilizing Megestrol Acetate?

Presently, Megestrol Acetate is being examined in 7 separate clinical trials. Out of those studies, 2 are currently running Phase 3 evaluations. While the majority of research on this treatment takes place in Winston-Salem, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a> there are 85 different locations conducting these experiments.

Q: How many sites are undertaking this investigation?

There are 8 sites that are currently enrolling participants in this examination, including Boston, Providence and Nashville. To reduce the burden of transportation costs associated with participating, it is advised to select a location close to your residence.

Q: Does the trial extend to persons of advanced age?

To be accepted in this trial, patients must lie between 9 and 108 months old. 47 trials are available for participants below the age of majority while 54 have been designed with those over 65 years-old in mind.

Q: What clinical conditions is Megestrol Acetate typically prescribed for?

Megestrol Acetate is frequently used to provide palliative care as well as address conditions such as recurrent endometrial carcinoma, <a href="https://www.withpower.com/clinical-trials/weight-loss">weight loss</a>, and cachexia.

Q: Is this experiment accepting new participants at the current time?

Indeed, per the data available on clinicaltrials.gov this medical trial is still accepting candidates. The research was originally posted on August 15th 2019 and has been updated as recently as February 28th 2022. A total of 60 participants are needed across 8 sites for the study to be completed.

Q: What is the aggregate size of this medical experiment's participant base?

Affirmative. The clinical trial was initially posted on August 15th 2019, and is currently open for recruitment according to the information available through clinicaltrials.gov. Eight different medical sites are required to recruit a total of 60 patients into the study.

Phase 4

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 to 14 weeks

Awards & highlights

iKanEat 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.Check my eligibility

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.See study design

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.

iKanEat Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 9 months and 9 years old.

iKanEat Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in % kilocalories/day obtained orally

Secondary outcome measures

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%

Pain: Abdomen NOS

23%

Nausea

17%

Distension/bloating, abdominal

17%

Mood alteration: Depression

13%

Dyspnea (shortness of breath)

13%

Gastrointestinal - Other: Increased Appetite

13%

Insomnia

13%

Urinary frequency/urgency

10%

Neuropathy: sensory

10%

Hot flashes/flushes

10%

Constitutional Symptoms - Other: thirst

10%

Pain: Back

10%

Constipation

10%

Mood alteration: Anxiety

Vaginal discharge (non-infectious)

Hypertension

Dry skin

Pain: Chest/thorax NOS

Pain: Throat/pharynx/larynx

Pain - Other: side of body

Sweating (diaphoresis)

Dermatology/Skin - Other: blister

Rigors/chills

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

Cystitis

Dermatology/Skin - Other: skin peeling

Dysphagia (difficulty swallowing)

Edema: head and neck:

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

Flatulence

Flu-like syndrome

Flushing

Glucose, serum-low (hypoglycemia)

Hypotension

Libido

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

Odor (patient odor)

Pain: Extremity-limb

Pain: Muscle

Pain: Neuralgia/peripheral nerve

Pain: Pleura

Pain: Vagina

Proteinuria

Pruritus/itching

Rash/desquamation

Rash: acne/acneiform

Urticaria (hives, welts, wheals)

Vomiting

pain: stomach

Anorexia

Pain: Pain NOS

Thrombosis/thrombus/embolism

Allergic reaction/hypersensitivity (including drug fever)

Irregular menses (change from baseline)

Confusion

Diarrhea

Dizziness

Memory impairment

Mood alteration: Agitation

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

Musculoskeletal/Soft Tissue - Other: Spasm

Renal/Genitourinary - Other: Burning With Urination

Pain: Pelvis

100%

80%

60%

40%

20%

Study treatment Arm

Megestrol Acetate

iKanEat 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

462 Previous Clinical Trials

169,147 Total Patients Enrolled

Media Library

iKanEat Behavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03815019 — Phase 4

Failure to Thrive Research Study Groups: Megestrol, Placebo

Failure to Thrive Clinical Trial 2023: iKanEat Behavioral Intervention Highlights & Side Effects. Trial Name: NCT03815019 — Phase 4

iKanEat Behavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03815019 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I participate in this clinical experiment?

"This experiment will involve 60 subjects between the ages of 9 months and 8 years old that are currently diagnosed with an eating disorder. In addition to this, they must have a G or G/J tube in place, adequate oral motor skills for consuming food, and behavioral capacity necessary for mealtime routines."

Answered by AI

Has the United States Food and Drug Administration sanctioned Megestrol Acetate?

"According to our assessment, Megestrol Acetate has been granted a safety score of 3 due to it being approved by the FDA in Phase 4 clinical trials."

Answered by AI

Have there been antecedent experiments utilizing Megestrol Acetate?

"Presently, Megestrol Acetate is being examined in 7 separate clinical trials. Out of those studies, 2 are currently running Phase 3 evaluations. While the majority of research on this treatment takes place in Winston-Salem, North carolina there are 85 different locations conducting these experiments."

Answered by AI

How many sites are undertaking this investigation?

"There are 8 sites that are currently enrolling participants in this examination, including Boston, Providence and Nashville. To reduce the burden of transportation costs associated with participating, it is advised to select a location close to your residence."

Answered by AI

Does the trial extend to persons of advanced age?

"To be accepted in this trial, patients must lie between 9 and 108 months old. 47 trials are available for participants below the age of majority while 54 have been designed with those over 65 years-old in mind."

Answered by AI

What clinical conditions is Megestrol Acetate typically prescribed for?

"Megestrol Acetate is frequently used to provide palliative care as well as address conditions such as recurrent endometrial carcinoma, weight loss, and cachexia."

Answered by AI

Is this experiment accepting new participants at the current time?

"Indeed, per the data available on clinicaltrials.gov this medical trial is still accepting candidates. The research was originally posted on August 15th 2019 and has been updated as recently as February 28th 2022. A total of 60 participants are needed across 8 sites for the study to be completed."

Answered by AI

What is the aggregate size of this medical experiment's participant base?

"Affirmative. The clinical trial was initially posted on August 15th 2019, and is currently open for recruitment according to the information available through clinicaltrials.gov. Eight different medical sites are required to recruit a total of 60 patients into the study."

Answered by AI