LeukemiaPhase 2NCT00949117
Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
A Phase 2 study testing Ensure, PediaSure and cyproheptadine hydrochloride in people with Leukemia and Lymphoma, run by University of South Florida.
Trial summary
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Leukemia, Lymphoma, Malnutrition
- What is being tested?
- Ensure, PediaSure and cyproheptadine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 2 years and < 18 years of age at the time of admission to the study
- Meets one of the following criteria:
- documented history of unintended weight loss > 5% presumed secondary to cancer/treatment-related therapy within three months
- BMI for age less than the 5th percentile
- Diagnosed with cancer of any type
- Concomitant cancer treatment (surgery, chemotherapy, radiotherapy) guidelines:
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- Patients who will complete concomitant cancer treatment during this study's 4-week intervention are not eligible
- If patients are receiving concomitant cancer treatment, they should be scheduled to get at least another 4 weeks of treatment in order to reach the primary endpoint
- If patients have already completed cancer treatment, they need to be enrolled within 8 weeks of completing therapy.
- Predicted life expectancy of at least 6 months
Who cannot join
- Currently taking any of the study agents (cyproheptadine hydrochloride (CH), PediaSure, or Ensure) or have taken any of the study agents during the past 3 weeks
- History of anorexia nervosa or bulimia
- Initiation of other appetite enhancing agents including steroids prescribed for the intent of weight gain, i.e. Megace, is not allowed during this study
- Children receiving steroids as part of their daily cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen or in other pulse steroid therapy is allowed during the study.
- Use of other forms of nutrition therapies, e.g. total parenteral nutrition (TPN) or enteral tube feedings within 3 weeks of study entry or during study
- Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (SSRI), or paroxetine (SSRI)
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- Taking dronabinol (Marinol) or other appetite-stimulating medications during the past 3 weeks
- Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease or GI or genitourinary (GU) obstruction
- Allergy to study agents
- Hypersensitivity to specific milk proteins
- Pregnant or lactating. Females of childbearing potential are required to use effective contraception while on study agent.
About this study
Official title: An Open Label Randomized Phase II Study of an Appetite Stimulant, Cyproheptadine Hydrochloride, With and Without a Nutritional Supplement, in Children With Cancer/Treatment-Related Weight Loss
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.
PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.
Read the detailed description
OBJECTIVES:
Primary
- To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss.
Secondary
- To compare patterns of body composition and weight change in patients treated with these regimens.
- To compare the change in the relationship between pre-albumin (biomarker of malnutrition) and weight improvement from baseline to the completion of study treatment.
- To compare the change in quality of life as measured by the Pediatric Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
- Arm II: Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Patients undergo blood sample collection to assess pre-albumin levels at baseline and at weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice a week during study treatment.
Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks 4 and 24.
- Conditions
- Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific, Weight Changes
- Being tested
- Ensure, PediaSure, cyproheptadine hydrochloride
- Keywords
- malnutrition, weight changes, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia, other myeloid malignancies, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, recurrent childhood anaplastic large cell lymphoma, stage I childhood anaplastic large cell lymphoma, stage II childhood anaplastic large cell lymphoma, stage III childhood anaplastic large cell lymphoma, stage IV childhood anaplastic large cell lymphoma, recurrent childhood grade III lymphomatoid granulomatosis
- Medical subject headings
- Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes, Body Weight Changes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsureDietary supplement
Also called nutritional supplement drink
Given orally
PediaSureDietary supplement
Also called nutritional supplement drink (pediatric)
Given orally
cyproheptadine hydrochlorideDrug
Also called cyproheptadine HCl
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I- cyproheptadine hydrochloride | Experimental | Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity. Receives: Drug: cyproheptadine hydrochloride |
| cyproheptadine HCl & PediaSure or Ensure | Experimental | Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity. Receives: Dietary Supplement: Ensure; Dietary Supplement: PediaSure; Drug: cyproheptadine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Measures of Weight at Baseline and at Week 24
Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.
Measured: 24 weeks
Secondary outcomes (4)
Body Mass Index as Assessed at Baseline and 24 Weeks
Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.
Measured: 24 weeks
Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition
Measured: 24 weeks
Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24
Measured: 24 weeks
Change in Weight for Age Z-score From Baseline Through 24 Weeks
Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: study not feasible with low accrual. DSMB recommended closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marisa Couluris, DO, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949117
- Sponsor's protocol ID
- SCUSF 0802
- Other IDs
- SCUSF-0802, 5U10CA081920-11
- Status last verified
- Mar 2014
- First submitted
- 29 Jul 2009
- Last updated
- 2 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Phase II Study of an Appetite Stimulant, Cyproheptadine Hydrochloride, With and Without a Nutritional Supplement, in Children With Cancer/Treatment-Related Weight Loss
- ClinicalTrials.gov ID
- NCT00949117
- Acronym / sponsor ID
- SCUSF 0802
- Conditions
- Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific, Weight Changes
- Keywords
- malnutrition, weight changes, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, untreated childhood acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study not feasible with low accrual. DSMB recommended closure
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.
PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.
Detailed description
OBJECTIVES:
Primary
- To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss.
Secondary
- To compare patterns of body composition and weight change in patients treated with these regimens.
- To compare the change in the relationship between pre-albumin (biomarker of malnutrition) and weight improvement from baseline to the completion of study treatment.
- To compare the change in quality of life as measured by the Pediatric Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
- Arm II: Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Patients undergo blood sample collection to assess pre-albumin levels at baseline and at weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice a week during study treatment.
Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks 4 and 24.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I- cyproheptadine hydrochloride | Experimental | Drug: cyproheptadine hydrochloridePatients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity. |
| cyproheptadine HCl & PediaSure or Ensure | Experimental | Dietary Supplement: Ensure, Dietary Supplement: PediaSure, Drug: cyproheptadine hydrochloridePatients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- ≥ 2 years and < 18 years of age at the time of admission to the study
- Meets one of the following criteria:
- documented history of unintended weight loss > 5% presumed secondary to cancer/treatment-related therapy within three months
- BMI for age less than the 5th percentile
- Diagnosed with cancer of any type
Key exclusion criteria (11 listed)
- Currently taking any of the study agents (cyproheptadine hydrochloride (CH), PediaSure, or Ensure) or have taken any of the study agents during the past 3 weeks
- History of anorexia nervosa or bulimia
- Initiation of other appetite enhancing agents including steroids prescribed for the intent of weight gain, i.e. Megace, is not allowed during this study
- Children receiving steroids as part of their daily cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen or in other pulse steroid therapy is allowed during the study.
- Use of other forms of nutrition therapies, e.g. total parenteral nutrition (TPN) or enteral tube feedings within 3 weeks of study entry or during study
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 |
|---|---|---|
| EnsureAlso: nutritional supplement drinkGiven orally | Dietary supplement | cyproheptadine HCl & PediaSure or Ensure |
| PediaSureAlso: nutritional supplement drink (pediatric)Given orally | Dietary supplement | cyproheptadine HCl & PediaSure or Ensure |
| cyproheptadine hydrochlorideAlso: cyproheptadine HClGiven orally | Drug | Arm I- cyproheptadine hydrochloride, cyproheptadine HCl & PediaSure or Ensure |
Primary outcome
Difference Between Measures of Weight at Baseline and at Week 24
Time frame: 24 weeks
Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.
4 secondary outcomes
Body Mass Index as Assessed at Baseline and 24 Weeks
Time frame: 24 weeks
Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition
Time frame: 24 weeks
Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24
Time frame: 24 weeks
Change in Weight for Age Z-score From Baseline Through 24 Weeks
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marisa Couluris, DO study chair
University of South Florida
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensure, PediaSure and cyproheptadine hydrochloride in people with Leukemia and Lymphoma, run by University of South Florida.
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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference Between Measures of Weight at Baseline and at Week 24 (time frame: 24 weeks). 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 2 Apr 2014.