A Randomized, Double Blind, Placebo-Controlled Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
N/A
18 Years
Both
Malnourished Children With Cancer
Trial Information
A Randomized, Double Blind, Placebo-Controlled Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
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 the results are within normal limits, we will proceed on to the
Randomization Phase. If the results are not within normal limits for your/your child's age,
then you/your child will not be able to proceed with the study and we will pass these test
results on to your regular oncologist.
Randomization Phase If you/your child agree to take part in this study you/your child will
have an equal chance of receiving one of two possible liquids: Megace (7.5 mg/kg/day taken
once in the morning) or the same amount of a placebo (a placebo is a substance that looks
and tastes exactly like the real medicine, however it is an inactive substance that contains
no drug). This assigning to the drug or the placebo is called randomization. Neither you
nor your physician can choose or know which treatment you are receiving. This "blinding" is
necessary to fairly test these drugs. In an emergency, your physician can immediately find
out which of the drugs/treatments you are receiving.
Once randomized, you/your child will be given a supply of the drug or the placebo. Both the
drug and the placebo are a lemon-lime flavored liquid. There are no pills or tablets to
take. You/your child are to take the liquid by mouth in the amount prescribed once per day.
You will take the liquid every day for 90 days (3 months). The liquid is to be taken half
an-hour before breakfast.
Pre-treatment Information Collection Phase Before you/your child start taking the liquid, we
will collect some initial information. This will include taking your/your child's weight
and height. A dietitian will perform an assessment of you/your child's body composition
using a tool called a caliper. This will briefly pinch the skin at the back of your/your
child's arm. It will not hurt. The dietitian will also measure your/your child's upper
arms using a tape measure.
A research nurse will ask a series of questions called a Quality of Life assessment. This
will tell us about how you/your child feels before starting the study.
Afterwards, you/your child will have a scan called a DEXA (stands for Dual Energy X-Ray
Absorptiometry) scan done to assess your/your child's body composition. A DEXA scan does
not hurt but requires that you/your child lie still on the table while the scanner moves
over you/your child. Like all scans, there is some radiation exposure. However, the total
amount of radiation is very small (about half the radiation exposure of a normal chest
xray). This should not cause any problem for you/your child.
We will also draw some additional blood (approximately 1 teaspoon) from your central line.
You/your child will not have extra pokes for the purposes of this study.
Follow-up Phase You/your child will be followed closely by our team of doctors and
dieticians during the 90 days you/your child are on the study. Follow-up will occur when
you are normally scheduled to see your doctor. This can occur at either the Pediatric
Oncology outpatient clinics or when you are admitted to the BC Children's Hospital
(Vancouver) or Stollery Children's Hospital (Edmonton). You do not have to make special
appointments for the purpose of this study.
We will watch your weight closely during the 3 months of the study. If you/your child lose
an additional 15% from your/your child's baseline (starting) weight we will stop you taking
the medication or placebo. You will then receive regular medical care. This may include
starting tube feeding or TPN.
We will also take additional blood work at least every 2 weeks during the 3 months. This
can be done through your/your child's central line at times when regular blood work is being
drawn. Once a month our research nurse will contact you by phone to see how things are
going and ask questions about possible side effects.
Study Conclusion Phase At the end of the study we will again collect all the information as
we did in the Pre-treatment Information Collection Phase. This will include your/your
child's weight, height, caliper and arm measurements as well as asking the same quality of
life questions. You will then have a second DEXA scan done.
After 90 days you will be told whether you received the drug (Megace) or the inactive
substance (Placebo).
The time commitment for you/your child to take part in this research should be minimal.
Each DEXA scan (you/your child are asked to complete 2 DEXA scans during the study) will
take approximately 1 hour. Each study nurse interview (3) should take approximately 10-15
minutes each time. The quality of life questions will be asked three times and take
approximately 5-10 minutes each time to complete.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
Unspecified
Safety Issue:
No
Principal Investigator
David Dix, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of British Columbia
Authority:
Canada: Health Canada
Study ID:
H06-03499
NCT ID:
NCT00439101
Start Date:
April 2007
Completion Date:
April 2012
Related Keywords:
- Malnourished Children With Cancer
- weight loss
- malignancy
- corticosteroids
- supplemental feeding
- adrenal insufficiency
- diabetes
- Malnutrition
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