Trial Outcomes & Findings for Multimodal Treatment Strategy for Cancer Cachexia (NCT NCT00625742)
NCT ID: NCT00625742
Last Updated: 2016-02-12
Results Overview
Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline to Day 29, approximately 30 days
Results posted on
2016-02-12
Participant Flow
Recruitment Period: February 18, 2008 to December 15, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Early termination of the study due to follow-up issues and low recruitment numbers.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Disease Progression
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Multimodal Treatment Strategy for Cancer Cachexia
Baseline characteristics by cohort
| Measure |
Multimodal Treatment Strategy
n=15 Participants
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.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 29, approximately 30 daysPopulation: 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.
Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 29, approximately 30 daysPopulation: 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.
Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).
Outcome measures
Outcome data not reported
Adverse Events
Multimodal Treatment Strategy
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multimodal Treatment Strategy
n=15 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Dry Mouth
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
13.3%
2/15 • Number of events 2 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Musculoskeletal and connective tissue disorders
Cord Compression
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
Other adverse events
| Measure |
Multimodal Treatment Strategy
n=15 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 2 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
6/15 • Number of events 8 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Depressed level of consciousness
|
26.7%
4/15 • Number of events 4 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Number of events 4 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Dry mouth
|
40.0%
6/15 • Number of events 6 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Fatigue
|
60.0%
9/15 • Number of events 9 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Vascular disorders
Hemorrhage nasal
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 6 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Neurology (Other)
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Oral pain
|
13.3%
2/15 • Number of events 2 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Musculoskeletal and connective tissue disorders
Pain, Muscle
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
General disorders
Pain (Other)
|
33.3%
5/15 • Number of events 5 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
2/15 • Number of events 2 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Cardiac disorders
Syncope vasovagal
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Adverse event data collection from baseline to day 29 (+/- 3 days). Overall collection period: October 24, 2008 to January 24, 2011.
|
Additional Information
Rony Dev, DO/Associate Professor, Palliative Care Med
University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place