Status:
TERMINATED
Multimodal Treatment Strategy for Cancer Cachexia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancer
Cachexia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary aim of this proposal is to present a novel, multimodal treatment strategy for increasing lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- ...
Detailed Description
The Study Drugs: Melatonin is a hormone that helps reduce inflammation and poor food absorption caused by cancer. It may also enhance the effects of ibuprofen. Juven is a nutritional supplement that...
Eligibility Criteria
Inclusion
- Are referred to the Cachexia Clinic with involuntary weight loss of \>5% of their premorbid weight within the previous 6 months.
- Are 18 years of age or older
- Have a Karnofsky performance score of 60 or higher.
- Can maintain oral food intake during the study
- Can understand the study procedures and can sign an informed consent form.
- Are not currently taking melatonin.
- Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy.
- Have a calculated creatinine clearance of \>/= 60 cc/min.
Exclusion
- Have dementia or delirium (as determined by the palliative care specialist) at study entry.
- Are pregnant
- Have been taking corticosteroids for longer than 48 hours.
- Have pulmonary edema, ascites or pitting edema on clinical examination.
- Are unable to walk.
- Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.
- Have an ALT/AST\>3x upper limit of normal.
- Patients on methotrexate.
- Patients taking melatonin receptor agonists (such as Rozerem® \[ramelteon\]).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00625742
Start Date
February 1 2008
End Date
June 1 2014
Last Update
February 12 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030