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Multimodal Treatment Strategy for Cancer Cachexia

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, February 2008

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00625742
  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, ibuprofen, and beta-blockers).

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
Drug: Ibuprofen
Drug: Atenolol
Dietary Supplement: Juven

MedlinePlus related topics:   Cancer    Dietary Supplements    Exercise and Physical Fitness   

ChemIDplus related topics:   Ibuprofen    Dexibuprofen    Atenolol    Phenylephrine    Guaifenesin    Naphazoline    Naphazoline hydrochloride    Oxymetazoline    Oxymetazoline hydrochloride    Phenylephrine hydrochloride    Phenylpropanolamine    Phenylpropanolamine hydrochloride    Melatonin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:
  • To learn if the experimental study treatment (resistance training, aerobic exercise, and the use of atenolol, ibuprofen, melatonin, and Juven) can help to increase lean body mass (everything except fat) in cancer patients who experience cachexia. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   February 2008
Estimated Primary Completion Date:   February 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven)
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 PO Daily
Drug: Ibuprofen
400 mg PO Three Times Daily
Drug: Atenolol
25 mg PO daily if evidence of resting heart rate >110 b/min) or REE > 110% of predicted.
Dietary Supplement: Juven
90 calories of Juven, twice a day.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Are referred to the Cachexia Clinic with involuntary weight loss of >5% of their premorbid weight within the previous 6 months.
  • Are 18 years of age or older
  • Have a Karnofsky performance score of 60 or higher.
  • Can maintain oral food intake during the study
  • Can understand the study procedures and can sign an informed consent form.
  • Are not currently taking melatonin, a beta-blocker,a combination alpha and beta blocker or a non-steroidal-anti-inflammatory drug(NSAID).
  • Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy.
  • Have a calculated creatinine clearance of >/= 60 cc/min

Exclusion Criteria:

  • Have dementia or delirium (as determined by the palliative care specialist) at study entry.
  • Are pregnant
  • Severe sinus bradycardia with a heart rate of < 45 beat/min,atrial fibrillation with an uncontrolled ventricular response,a high degree Atrioventricular block,a history of congestive heart failure;a history of myocardial infarction or stroke within the past 3 months, a history of hypertrophic cardiomyopathy; a history of moderate to severe stenotic valvular heart disease.
  • Have been taking corticosteroids for longer than 48 hours.
  • Have pulmonary edema, ascites or pitting edema on clinical examination.
  • Are unable to walk.
  • Hypersensitivity to ibuprofen or a history of asthma, urticaria or allergic-type reactions after taking aspirin or other NSAID's
  • Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.
  • Have symptoms of dyspepsia or a history of uncomplicated peptic ulcer disease and are unable to add a proton pump inhibitor to their medication.
  • Are older than 65 years, have a hemoglobin level <9 g/dl, platelet count less than 50 000/mm3, calculated creatinine clearance level of less than 60 cc/min, or ALT/AST>3x upper limit of normal.
  • Have a history of hypersensitivity or allergy to beta-blockers,or a history of uncontrolled bronchial asthma or severe chronic obstructive pulmonary disease.
  • Patients on methotrexate.
  • Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]).
  • Patients that, after discussion between the primary oncologist and the palliative care specialist, the oncologist is of the opinion that anti-neoplastic therapy is more likely to improve the cachexia and its associated quality of life.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625742

Contacts
Contact: Egidio Del Fabbro, MD     713-792-6085    

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Egidio Del Fabbro, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Egidio Del Fabbro, MD     U.T.M.D. Anderson Cancer Center    
  More Information

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Egidio Del Fabbro, MD/Assistant Professor )
Study ID Numbers:   2006-0739
First Received:   February 19, 2008
Last Updated:   February 19, 2008
ClinicalTrials.gov Identifier:   NCT00625742
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Ibuprofen
Cachexia
Emaciation
Body Weight
Naphazoline
Signs and Symptoms
Oxymetazoline
Phenylephrine
Guaifenesin
Weight Loss
Body Weight Changes
Melatonin
Phenylpropanolamine
Atenolol

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Anti-Arrhythmia Agents
Analgesics
Sympatholytics
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Autonomic Agents
Analgesics, Non-Narcotic
Adrenergic Antagonists
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2008




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