Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer… (NCT00066248) | Clinical Trial Compass
CompletedPhase 2
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
United States, Canada, Puerto Rico70 participantsStarted 2003-06
Plain-language summary
RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.
PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.
Who can participate
Age range
2 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following:
* documented history of weight loss \> 5%
* drop in growth rate two or more percentile ranks on standard growth charts,
* weight for height less than the tenth percentile.
* Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.
* Patients who are receiving active or palliative therapy are eligible.
* If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible.
* Patients must be ≥ 2 years and \< 21 years of age at the time of admission to this study.
* Patients must have a predicted life expectancy of at least eight weeks.
EXCLUSION CRITERIA:
* Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible.
* Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace.
* Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment