Multimodal Treatment Strategy for Cancer Cachexia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00625742|
Recruitment Status : Terminated (Low Accrual)
First Posted : February 28, 2008
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Cachexia||Behavioral: Graded Resistance Training Behavioral: Aerobic Exercise Drug: Melatonin Dietary Supplement: Juven Drug: Atenolol Drug: Ibuprofen||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Multimodal Treatment Strategy
Exercise Program + Pharmacologic Intervention (Melatonin + Atenolol + Ibuprofen) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes at 70-80% of maximum predicted heart rate. Melatonin 20 mg by mouth (PO) Daily. 90 calories of Juven, twice a day.
Behavioral: Graded Resistance Training
Resistance training sessions twice weekly using Thera-bands.Behavioral: Aerobic Exercise
Walking or running for 3-4 minutes at 70-80% of your maximum predicted heart rate.Drug: Melatonin
20 mg by mouth (PO) DailyDietary Supplement: Juven
90 calories of Juven, twice a day.Drug: Atenolol
Atenolol will only be taken if there's evidence of increased sympathetic activity (resting heart rate >110 beats/min) or resting energy expenditure (REE) > 110% of predicted.Drug: Ibuprofen
Ibuprofen 1200mg/day in three divided doses.
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625742
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rony Dev, DO||M.D. Anderson Cancer Center|