Clinical Trial: Multimodal Treatment Strategy for Cancer Cachexia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia

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 (+/- 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).


Detailed Summary:

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 is designed to help build muscle and slow muscle breakdown.

Screening Tests:

Before you can start treatment on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests will be performed:

  • Blood (1 to 2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
  • Additional blood (1 tablespoon) will be drawn to check your thyroid function and the levels of two B vitamins, if these have not been checked within the past 3 months.
  • You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate).
  • You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
  • Your resting energy expenditure (energy used at rest) will be measured. with a calorie-measuring device. For this test, you will breathe in and out through your mouth for about 10 minutes to allow a calorie-measuring device to measure the oxygen your body uses, and from this it calculates how much energy your body uses at rest.
  • You will be asked to fill out a questionnaire to rate
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Participant Gain in Lean Body Mass [ Time Frame: Baseline to Day 29, approximately 30 days ]

    Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).


    Original Primary Outcome: To learn if the experimental study treatment (resistance training, aerobic exercise, and the use of atenolol, ibuprofen, melatonin, and Juven) can help to increase lean body mass (everything except fat) in cancer patients who experience cachexia. [ Time Frame: 1 Year ]

    Current Secondary Outcome: Improvement of Clinical Outcomes [ Time Frame: Baseline to Day 29, approximately 30 days ]

    Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).


    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: February 19, 2008
    Date Started: February 2008
    Date Completion:
    Last Updated: January 8, 2016
    Last Verified: January 2016