Malnourished Children With CancerNCT00439101
A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
A study testing Megstrol Acetate in people with Malnourished Children With Cancer, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Malnourished Children With Cancer
- What is being tested?
- Megstrol Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2007to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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:
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Stollery Children's Hospital
Edmonton, British Columbia, T6G 2B7
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
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.
Read the 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 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.
- Conditions
- Malnourished Children With Cancer
- Being tested
- Megstrol Acetate, Placebo
- Keywords
- weight loss, malignancy, corticosteroids, supplemental feeding, adrenal insufficiency, diabetes
- Medical subject headings
- Weight Loss, Neoplasms, Adrenal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megstrol AcetateDrug
Megestrol acetatet 7.5 mg/kg/day orally (lemon-lime suspension) for 90 days.
PlaceboOther
Placebo (lemon-lime suspension) taken orally for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Megstrol Acetate |
| 2 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (5)
• 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).
To investigate whether MA has a beneficial effect on body composition using dual-energy x-ray absorptiometry (DXA).
To determine if appetite stimulation following MA therapy results in improved quality of life for children with cancer-associated cachexia.
To determine if MA results in fewer requirements for invasive nutritional support such as tube feeding, gastrostomy tubes, and TPN.
To evaluate toxicities associated with MA in pediatric oncology subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnourished Children With CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Sponsor
- Investigators
- David Dix, MD, Principal investigator, University of British ColumbiaBeverly Wilson, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439101
- Sponsor's protocol ID
- H06-03499
- Other IDs
- CW06- 0294
- Status last verified
- Jul 2012
- First submitted
- 21 Feb 2007
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
- ClinicalTrials.gov ID
- NCT00439101
- Acronym / sponsor ID
- H06-03499
- Conditions
- Malnourished Children With Cancer
- Keywords
- weight loss, malignancy, corticosteroids, supplemental feeding, adrenal insufficiency, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- Apr 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Megstrol Acetate |
| 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megstrol AcetateMegestrol acetatet 7.5 mg/kg/day orally (lemon-lime suspension) for 90 days. | Drug | 1 |
| PlaceboPlacebo (lemon-lime suspension) taken orally for 90 days. | Other | 2 |
Primary outcome
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.
5 secondary outcomes
• 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).
To investigate whether MA has a beneficial effect on body composition using dual-energy x-ray absorptiometry (DXA).
To determine if appetite stimulation following MA therapy results in improved quality of life for children with cancer-associated cachexia.
To determine if MA results in fewer requirements for invasive nutritional support such as tube feeding, gastrostomy tubes, and TPN.
To evaluate toxicities associated with MA in pediatric oncology subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
Related trials for Malnourished Children With Cancer
Recruiting
Standardized Nutritional Management of Pediatric Patients With Solid Tumors
Tumor, Solid, Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Dix, MD principal investigator
University of British Columbia
Beverly Wilson, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Megstrol Acetate in people with Malnourished Children With Cancer, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.