Status:
COMPLETED
A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
University of Alberta
Conditions:
Malnourished Children With Cancer
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief 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 ra...
Detailed Description
Overview of the study phases Prior to the randomization phase, we will draw some blood work (1 teaspoon) with regular blood work to see if you/your child meet the final eligibility requirements. If th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00439101
Start Date
April 1 2007
End Date
April 1 2012
Last Update
July 13 2012
Active Locations (2)
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1
Stollery Children's Hospital
Edmonton, British Columbia, Canada, T6G 2B7
2
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4