Multimodal Treatment Strategy for Cancer Cachexia

Stopped early · Not applicable

Conditions studied: Advanced Cancer, Cachexia

In brief

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 (+/- 3 days). The strategy includes graded resistance training and aerobic exercise, targeted nutrient supplementation and pharmacologic intervention (melatonin). We postulate that this strategy, together with the simultaneous management of symptoms that decrease appetite (e.g. depression, pain, and nausea), will also accomplish our secondary objectives of improving clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).

Key facts

Study ID

NCT00625742

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2008-02-01

Expected to finish

2014-06-01

Last updated by the study team

2016-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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]).

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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