Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 15
Recruitment Details Recruitment Period: February 18, 2008 to December 15, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details Early termination of the study due to follow-up issues and low recruitment numbers.
Arm/Group Title Multimodal Treatment Strategy
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 15
Completed 3
Not Completed 12
Reason Not Completed
Disease Progression             2
Withdrawal by Subject             1
Adverse Event             4
Lost to Follow-up             4
Ineligible             1
Arm/Group Title Multimodal Treatment Strategy
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
57
(34 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
3
  20.0%
Male
12
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Participant Gain in Lean Body Mass
Hide Description Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).
Time Frame Baseline to Day 29, approximately 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.
Arm/Group Title Multimodal Treatment Strategy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Improvement of Clinical Outcomes
Hide Description Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).
Time Frame Baseline to Day 29, approximately 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.
Arm/Group Title Multimodal Treatment Strategy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multimodal Treatment Strategy
Hide Arm/Group Description 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.
All-Cause Mortality
Multimodal Treatment Strategy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Multimodal Treatment Strategy
Affected / at Risk (%) # Events
Total   7/15 (46.67%)    
Gastrointestinal disorders   
Gastrointestinal Hemorrhage  1  2/15 (13.33%)  2
General disorders   
Dry Mouth  1  1/15 (6.67%)  1
Fatigue  1  1/15 (6.67%)  1
Fever  1  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Cord Compression  1  1/15 (6.67%)  1
Fracture  1  1/15 (6.67%)  1
Nervous system disorders   
Dizziness  1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Multimodal Treatment Strategy
Affected / at Risk (%) # Events
Total   10/15 (66.67%)    
Cardiac disorders   
Syncope vasovagal  1  1/15 (6.67%)  1
Gastrointestinal disorders   
Anorexia  1  1/15 (6.67%)  1
Constipation  1  6/15 (40.00%)  8
Diarrhea  1  1/15 (6.67%)  1
Nausea  1  6/15 (40.00%)  6
Vomiting  1  1/15 (6.67%)  1
General disorders   
Dry mouth  1  6/15 (40.00%)  6
Fatigue  1  9/15 (60.00%)  9
Oral pain  1  2/15 (13.33%)  2
Pain (Other)  1  5/15 (33.33%)  5
Musculoskeletal and connective tissue disorders   
Pain, Muscle  1  1/15 (6.67%)  1
Nervous system disorders   
Anxiety  1  1/15 (6.67%)  1
Depressed level of consciousness  1  4/15 (26.67%)  4
Dizziness  1  3/15 (20.00%)  4
Headache  1  1/15 (6.67%)  1
Insomnia  1  3/15 (20.00%)  3
Neurology (Other)  1  1/15 (6.67%)  1
Peripheral sensory neuropathy  1  2/15 (13.33%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/15 (6.67%)  2
Rash desquamating  1  1/15 (6.67%)  1
Vascular disorders   
Hemorrhage nasal  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
The sample size of the available data is too small to detect any significant differences.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rony Dev, DO/Associate Professor, Palliative Care Med
Organization: University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
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 )
First Submitted: February 19, 2008
First Posted: February 28, 2008
Results First Submitted: December 4, 2015
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016