Megestrol Acetate for Eating Disorders

Phase-Based Estimates
3
Effectiveness
3
Safety
Rhode Island Hospital, Providence, RI
Eating Disorders+2 More
Megestrol Acetate - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Eating Disorders

Study Summary

This study is evaluating whether a medication may help children transition from tube to oral feedings.

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Eligible Conditions

  • Eating Disorders
  • Feeding and Eating Disorders
  • Feeding Disorder of Infancy or Early Childhood
  • Feeding Behaviors

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Megestrol Acetate will improve 1 primary outcome and 3 secondary outcomes in patients with Eating Disorders. Measurement will happen over the course of Weeks 0 to 24.

10 to 14 weeks
Number of patients with adrenal insufficiency as measured by morning cortisol lab value
Week 0 to 24
Change in child quality of life as measured by the Infant Toddler Quality of Life scale (ITQOL47)
Weeks 0 to 24
Change in % kilocalories/day obtained orally
Change in parent stress as measured by the Pediatric Inventory for Parents (PIP36)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo
Megestrol
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Megestrol Acetate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

MegestrolMegestrol 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.
Placebo
Behavioral
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 to 14 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 to 14 weeks for reporting.

Who is running the study

Principal Investigator
A. D. A.
Prof. Ann Davis,, ABPP, PhD
University of Kansas Medical Center

Closest Location

Rhode Island Hospital - Providence, RI

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If a person consumes more than 80% of their daily calorie needs through a tube, they are classified as tube-dependent. show original
Subjects who have difficulties with feeding and have been diagnosed by a multidisciplinary team, as well as having permission from a physician, are eligible to participate in a weaning study show original
People aged between 9 months and 9 years old can give consent. show original
Ensure that you have written consent from the parents or legal guardians of any subjects before starting your research. show original
Subjects must have a tube that helps them digest food properly, either a G or G/J tube. show original
Subjects need to have the oral motor skills necessary to eat and they need to have the behavioral skills necessary to have mealtimes. show original

Patient Q&A Section

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

What is eating disorders?

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The present study illustrates that in all three major personality and clinical domains that were studied, the psychopathological profiles of EDNOS and PD patients differ from those of healthy controls. Further prospective research of the phenomenological profiles of these disorders in broader populations from which samples for research are obtained is necessary to refine the nosological profiles.

Unverified Answer

Can eating disorders be cured?

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Eating disorders cannot be cured (nor can eating disorders be avoided or prevented) as there is no single underlying cause of these disorders. The term 'curing' is therefore misleading in relation to eating disorders, especially as this can result in self-harm, as well as other negative long-term healthcare consequences.

Unverified Answer

What causes eating disorders?

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There is no single cause of eating disorders; rather there are several contributory factors including biological factors, familial factors, social and economic factors. Eating disorders occur in many different populations and many different ways, and most people with eating disorders don't engage in the risky behaviours that make them at increased risk for developing the disorder. It can be difficult to get people to disclose what may affect their mental health or their eating disorders.

Unverified Answer

What are common treatments for eating disorders?

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The most common treatment of an eating disorder is medication. Many medications are used, but not all can be helpful in every individual. For the short term, medication is generally prescribed, although in some cases this can be risky, such as in people who have a past drug addiction. In the long term, counselling and support can be used in conjunction with medication to help people manage the condition better. Other treatment options include psychotherapies, such as behavior modification or cognitive therapy and family support.

Unverified Answer

What are the signs of eating disorders?

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Eating disordered behaviours can manifest throughout an individual's lifetime in the form of bulimia nervosa, binge-eating disorder, and anorexia nervosa. Common features of these eating disorders include an increased concern with shape, body image, and the need to control appetite and self-esteem. If someone has experienced a family history of eating disorders it is imperative that clinicians be aware of these symptoms and consider evaluating potential eating disorders.

Unverified Answer

How many people get eating disorders a year in the United States?

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Eating Disorders appear to disproportionately affect women, the elderly, the poorer and those of ethnic minorities. This suggests that the need to accurately and thoroughly diagnose, care for, and treat eating disorders can have important implications for public mental health in the United States.

Unverified Answer

What are the common side effects of megestrol acetate?

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In our large-scale study, megestrol acetate exhibited the lowest rate (2.24%) of side effects. Most of the side effects were mild. More than half of the patients (58.6%) discontinued a course due to side effects. The side effects observed most commonly with megestrol acetate were injection site pain (1.65%), joint pain (1.53%), endometrial changes such as endometrial hyperplasia (0.56%) and fibroids (0.37%), abdominal pain (0.36%), and diarrhea (0.32%).

Unverified Answer

What is megestrol acetate?

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MPA produces a marked increase in libido and a significant reduction in appetite in patients with anorexia nervosa and bulimia nervosa. It appears to be a safe treatment, although its mechanism of action is not well researched.

Unverified Answer

Has megestrol acetate proven to be more effective than a placebo?

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Considering the results of this meta-analysis, megestrol acetate was more effective in reducing total symptom scores and enhancing the quality of life for women with abnormal uterine bleeding than either a non-nausea/pain placebo or a placebo with megestrol acetate, suggesting that it may be the preferred medication option for treatment of abnormal uterine bleeding.

Unverified Answer

What is the average age someone gets eating disorders?

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More than a third of individuals with eating disorders are younger than age 15. This underscores the continuing need for increased awareness of eating disorders among all clinicians and educators, particularly among those at higher risk for developing eating disorders and for those with eating disorders in their family histories.

Unverified Answer

What is the primary cause of eating disorders?

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The primary causes of eating disorders are mood, interpersonal or social issues, and biological in nature. There may still be other causes contributing. Further study is warranted to determine exactly what causes and precipitates those eating disorders. It is necessary to encourage patients to seek help and to learn how to manage their eating disorder if symptoms occur.

Unverified Answer

Have there been any new discoveries for treating eating disorders?

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There is some evidence that augmentation with baclofen can reduce binge eating in bulimia nervosa (BN) and binge-eating in anorexia nervosa (AN). Although it can be used as a treatment for BN, it is not a definitive treatment for AN and should not be used as a medication to control AN unless the AN patient is hospitalized or is not responding to medication.

Unverified Answer
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