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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: University of Alberta
• Treatments: Appetite Stimulants; Central Nervous System Stimulants; Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

1. 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.

2. Subjects with malignancy (except those covered in the exclusion criteria) either at diagnosis or during active therapy.

3. Subjects with relapsed disease are eligible for study.

4. Subjects on palliative therapy are eligible for study provided that the predicted life expectancy is at least 3 months.

5. Subjects must be <18 years at the time of admission to this study.

6. 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.

7. 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.

8. Signed informed consent must be obtained according to institutional guidelines before enrollment on study.

Exclusion Criteria:

1. Any child receiving nutritional intervention including supplemental enteral (nasogastric / nasojejunal / gastrostomy) or parenteral (TPN) nutrition.

2. 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.

3. 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.

4. Subjects concurrently prescribed other appetite-stimulating medications.

5. Subjects with hormone-sensitive tumors including meningiomas.

6. 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).

7. Subjects with a predicted life expectancy less than 3 months.