We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multimodal Treatment Strategy for Cancer Cachexia

This study has been terminated.
(Low Accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625742
First Posted: February 28, 2008
Last Update Posted: February 12, 2016
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.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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 Intervention
Advanced Cancer Cachexia Behavioral: Graded Resistance Training Behavioral: Aerobic Exercise Drug: Melatonin Dietary Supplement: Juven Drug: Atenolol Drug: Ibuprofen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 15
Study Start Date: February 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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) Daily
Dietary 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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are referred to the Cachexia Clinic with involuntary weight loss of >5% of their premorbid weight within the previous 6 months.
  2. Are 18 years of age or older
  3. Have a Karnofsky performance score of 60 or higher.
  4. Can maintain oral food intake during the study
  5. Can understand the study procedures and can sign an informed consent form.
  6. Are not currently taking melatonin.
  7. Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy.
  8. Have a calculated creatinine clearance of >/= 60 cc/min.

Exclusion Criteria:

  1. Have dementia or delirium (as determined by the palliative care specialist) at study entry.
  2. Are pregnant
  3. Have been taking corticosteroids for longer than 48 hours.
  4. Have pulmonary edema, ascites or pitting edema on clinical examination.
  5. Are unable to walk.
  6. Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.
  7. Have an ALT/AST>3x upper limit of normal.
  8. Patients on methotrexate.
  9. Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]).
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Rony Dev, DO M.D. Anderson Cancer Center
  More Information

Additional 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
Last Verified: January 2016

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Cancer Cachexia
Cachexia
Melatonin
Juven
Exercise Training
Weight Loss

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Ibuprofen
Atenolol
Melatonin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Central Nervous System Depressants
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents