A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer - Full Text View

Purpose

The purpose of this research study is to determine if megestrol acetate can be used as an appetite stimulant to improve weight gain in children with cancer and poor nutrition. The study design is a randomized, double blind, placebo controlled trial. Secondarily, we would like to determine what effect any improvement in weight has on body composition by DEXA scan. This includes whether the drug results in an increase in fat, fat-free mass, or both. If our patients gain weight we would like to know if it improves their quality of life. Finally, many children with cancer lose too much weight and require feeding to occur through a tube put down their nose into their stomach (NG feeding). The tube can be painful to put down and is uncomfortable when in. Some children may also require nutrition to be given into a vein (Total Parenteral Nutrition or TPN). We are trying to see if we can prevent these procedures from happening by having the subjects gain weight. This study will tell doctors if the drug truly works (or does not work) in children who are underweight.

Condition	Intervention
Malnourished Children With Cancer	Drug: Megstrol Acetate Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Placebo-Controlled Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Malnutrition Weight Control

Drug Information available for: Megestrol acetate

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

To determine if daily administration of megestrol acetate (MA) for 3 months compared to placebo prevents weight loss or improves weight gain in children with cancer-associated anorexia-cachexia. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• To investigate whether MA results in improvement in other anthropometric measures of nutritional status (e.g. weight-for-height, triceps skinfolds, mid upper-arm circumference). [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
To investigate whether MA has a beneficial effect on body composition using dual-energy x-ray absorptiometry (DXA). [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
To determine if appetite stimulation following MA therapy results in improved quality of life for children with cancer-associated cachexia. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
To determine if MA results in fewer requirements for invasive nutritional support such as tube feeding, gastrostomy tubes, and TPN. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
To evaluate toxicities associated with MA in pediatric oncology subjects. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	April 2007
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Megstrol Acetate Megestrol acetatet 7.5 mg/kg/day orally (lemon-lime suspension) for 90 days.
Placebo Comparator: 2 Placebo	Other: Placebo Placebo (lemon-lime suspension) taken orally for 90 days.

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Any subject with malnourishment presumed secondary to cancer or cancer- related therapy is eligible. Malnourishment is defined as one or more of the following at the time of enrollment on study:
- A documented weight loss of ≥ 5% not attributable to acute fluid losses.
- A weight deficit <90% expected for height, age and gender not attributable to acute fluid losses.
- A mid upper-arm circumference < 5th percentile for age and gender.
Subjects with malignancy (except those covered in the exclusion criteria) either at diagnosis or during active therapy.
Subjects with relapsed disease are eligible for study.
Subjects on palliative therapy are eligible for study provided that the predicted life expectancy is at least 3 months.
Subjects must be <18 years at the time of admission to this study.
Subjects to receive corticosteroids while on study are eligible provided they are not required for >7 days in a 6-week period. The beginning of the 6-week period is defined as the day the first dose of corticosteroids is taken.
Subjects who received >7 days of corticosteroids in the previous 6-weeks before entering the study are eligible provided they have not received corticosteroids in the preceding 14 days.
Signed informed consent must be obtained according to institutional guidelines before enrollment on study.

Exclusion Criteria:

Any child receiving nutritional intervention including supplemental enteral (nasogastric / nasojejunal / gastrostomy) or parenteral (TPN) nutrition.
Subjects expected to receive corticosteroids for >7 days in a 6-week period. The 6-week period will be defined as starting the first day the steroids are to be taken.
Subjects in the previous 6-weeks who received >7 days of corticosteroids AND who are not at least 14 days from their last dose of corticosteroids.
Subjects concurrently prescribed other appetite-stimulating medications.
Subjects with hormone-sensitive tumors including meningiomas.
Subjects with any of the following conditions:
- Adrenal insufficiency Defined as: A pre-study 8:00 AM serum cortisol lower than the defined limits of this study (see section 7.4) plus confirmation of adrenal insufficiency by an ACTH stimulation test.
- Diabetes Mellitus Defined as: A pre-study random chemstrip or venous blood glucose >10 mmol/L with confirmation by a fasting blood glucose the next morning greater than the normal limits defined for this study
- Pregnancy
- Subjects with acute illnesses deemed clinically significant by the study coordinator (e.g., sepsis, congestive heart failure, hypertensive crises, in intensive care unit, acute or chronic renal failure, acute or chronic hepatic failure).
- Subjects with previous or current thromboembolic conditions (excluding central venous thrombosis related to the placement of a central venous catheter).
Subjects with a predicted life expectancy less than 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439101

Locations

Canada, British Columbia
Stollery Children's Hospital
Edmonton, British Columbia, Canada, T6G 2B7
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4

Sponsors and Collaborators

University of British Columbia

University of Alberta

Investigators

Principal Investigator:	David Dix, MD	University of British Columbia
Principal Investigator:	Beverly Wilson, MD	University of Alberta

More Information

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00439101 History of Changes
Other Study ID Numbers:	H06-03499, CW06- 0294
Study First Received:	February 21, 2007
Last Updated:	July 11, 2012
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

weight loss
malignancy
corticosteroids

supplemental feeding
adrenal insufficiency
diabetes

Additional relevant MeSH terms:

Malnutrition
Nutrition Disorders
Central Nervous System Stimulants
Megestrol Acetate
Megestrol
Appetite Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013