CancerPhase 3NCT01132547
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
A Phase 3 study testing cyproheptadine hydrochloride in people with Cancer, run by University of South Florida at 14 sites in United States.
Trial summary
RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Cancer
- What is being tested?
- cyproheptadine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2010to Jan 2014
- Phase
- Phase 3
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥ 2 years and ≤ 21 years of age at the time of study entry
- Scheduled to receive chemotherapy for:
- Newly diagnosed:
- Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
- Intermediate or high-risk neuroblastoma
- Wilms' tumor (Stage III/IV)
Show all 12Show fewer
- Hepatoblastoma (Stage III/IV)
- Germ cell tumors (Stage III/IV)
- Brain tumors, including medulloblastoma, PNET and ependymomas
- AML
- Relapsed/recurrent disease (any patient)
- Able to register and randomize within 28 days of starting chemotherapy (registration /randomization and start of study agent may occur at anytime up to and including Day 28 after the initiation of chemotherapy)
Who cannot join
- ≥ 29 days after starting chemotherapy
- Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
- Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
- History of anorexia nervosa or bulimia
- Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
- Initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g. appetite-stimulating medications, TPN or enteral tube feedings are not allowed during this study.
Show all 12Show fewer
- Children receiving steroids for >7 days as part of their cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen is allowed during the study
- Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil)
- Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU obstruction
- Allergy to cyproheptadine HCl
- Females of childbearing age must not be pregnant.
- Female patients who are lactating must agree to stop breast-feeding.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Children's Hospital of Southwest Florida at Lee Memorial
Fort Myers, Florida, 33908
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207-8482
Miller Children's Hospital
Long Beach, California, 90806
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
Nemours Children's Hospital Pensacola
Pensacola, Florida, 32504
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, 78207
Children's National Medical Center
Washington D.C., District of Columbia, 20010
A.I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.
Secondary
- To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
- Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.
OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
- Arm II: Patients receive an oral placebo twice daily for 8 weeks.
Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.
Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.
- Conditions
- Cancer
- Being tested
- cyproheptadine hydrochloride, placebo
- Keywords
- cachexia, weight changes, nausea and vomiting, alveolar childhood rhabdomyosarcoma, anaplastic osteosarcoma, childhood alveolar soft-part sarcoma, childhood angiosarcoma, childhood epithelioid sarcoma, childhood fibrosarcoma, childhood gliosarcoma, childhood leiomyosarcoma, childhood liposarcoma, childhood neurofibrosarcoma, childhood synovial sarcoma, chondrosarcoma, chondrosarcomatous osteosarcoma, clear cell sarcoma of the kidney, embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, endometrial stromal sarcoma
- Medical subject headings
- Neoplasms, Cachexia, Body Weight Changes, Nausea, Vomiting, Hemangiosarcoma, Sarcoma, Fibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyproheptadine hydrochlorideDrug
Also called cyproheptadine HCl
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I cyproheptadine hydrochloride | Experimental | Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks. Receives: Drug: cyproheptadine hydrochloride |
| Arm II placebo | Placebo comparator | Patients receive an oral placebo twice daily for 8 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
Measured: 8 weeks
Severity of Weight Loss
Change from Baseline in Weight Z score
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Pattern of Weight in the Study Population
Change from Baseline in Weight
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: The study was terminated due to slow accrual.
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 CancerStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 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
- Jeffrey P. Krischer, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132547
- Sponsor's protocol ID
- SCUSF 0703
- Other IDs
- SCUSF-0703, 5U10CA081920-11
- Status last verified
- Jun 2015
- First submitted
- 26 May 2010
- Last updated
- 2 Jul 2015
- 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 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
- ClinicalTrials.gov ID
- NCT01132547
- Acronym / sponsor ID
- SCUSF 0703
- Conditions
- Cancer
- Keywords
- cachexia, weight changes, nausea and vomiting, alveolar childhood rhabdomyosarcoma, anaplastic osteosarcoma, childhood alveolar soft-part sarcoma, childhood angiosarcoma, childhood epithelioid sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to slow accrual.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 2 Jul 2015
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 prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.
Secondary
- To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
- Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.
OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
- Arm II: Patients receive an oral placebo twice daily for 8 weeks.
Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.
Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I cyproheptadine hydrochloride | Experimental | Drug: cyproheptadine hydrochloridePatients receive oral cyproheptadine hydrochloride twice daily for 8 weeks. |
| Arm II placebo | Placebo comparator | Other: placeboPatients receive an oral placebo twice daily for 8 weeks. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- ≥ 2 years and ≤ 21 years of age at the time of study entry
- Scheduled to receive chemotherapy for:
- Newly diagnosed:
- Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
- Intermediate or high-risk neuroblastoma
Key exclusion criteria (12 listed)
- ≥ 29 days after starting chemotherapy
- Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
- Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
- History of anorexia nervosa or bulimia
- Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
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 |
|---|---|---|
| cyproheptadine hydrochlorideAlso: cyproheptadine HClGiven orally | Drug | Arm I cyproheptadine hydrochloride |
| placeboGiven orally | Other | Arm II placebo |
Primary outcome
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
Time frame: 8 weeks
Severity of Weight Loss
Time frame: Baseline and 8 weeks
Change from Baseline in Weight Z score
1 secondary outcome
Pattern of Weight in the Study Population
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Jeffrey P. Krischer, PhD principal investigator
University of South Florida
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyproheptadine hydrochloride in people with Cancer, run by University of South Florida at 14 sites in United States.
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 12 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: stopped early, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Jul 2015). 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?
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 Jul 2015.