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Multimodal Treatment Strategy for Cancer Cachexia

This study has been terminated.
(Low Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00625742
First received: February 19, 2008
Last updated: January 8, 2016
Last verified: January 2016
Results First Received: December 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Advanced Cancer
Cachexia
Interventions: Behavioral: Graded Resistance Training
Behavioral: Aerobic Exercise
Drug: Melatonin
Dietary Supplement: Juven
Drug: Atenolol
Drug: Ibuprofen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: February 18, 2008 to December 15, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Early termination of the study due to follow-up issues and low recruitment numbers.

Reporting Groups
  Description
Multimodal Treatment Strategy Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.

Participant Flow:   Overall Study
    Multimodal Treatment Strategy  
STARTED     15  
COMPLETED     3  
NOT COMPLETED     12  
Disease Progression                 2  
Withdrawal by Subject                 1  
Adverse Event                 4  
Lost to Follow-up                 4  
Ineligible                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Multimodal Treatment Strategy Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.

Baseline Measures
    Multimodal Treatment Strategy  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Median (Full Range)
  57  
  (34 to 91)  
Gender  
[units: participants]
 
Female     3  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     15  



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The sample size of the available data is too small to detect any significant differences.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rony Dev, DO/Associate Professor, Palliative Care Med
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00625742     History of Changes
Other Study ID Numbers: 2006-0739
NCI-2012-01744 ( Registry Identifier: NCI CTRP )
Study First Received: February 19, 2008
Results First Received: December 4, 2015
Last Updated: January 8, 2016
Health Authority: United States: Institutional Review Board