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Study Summary
No. 2006-0739:.......Advanced Cancers......Egidio Del Fabbro......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:
2006-0739
Study Title:An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia
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Physician New Patient Referral
Name:Egidio Del FabbroPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:792-6085
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:N/AReturn
Visit:
Two return visits - day 15 (+/- 3 days) and day 29 (+/- 3 days).
Treatment
Agents:
Atenolol
Ibuprofen
Melatonin
Home Care:All physician visits will be at MDACC. The exercise program will be done at
home after an initial out-patient evaluation.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is 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.
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Study Objectives / Outcomes
  • 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).
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:02/18/2008
Study Type:Other
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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, a beta-blocker,a combination alpha and beta blocker or a non-steroidal-anti-inflammatory drug(NSAID).

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) 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.

4) Have been taking corticosteroids for longer than 48 hours.

5) Have pulmonary edema, ascites or pitting edema on clinical examination.

6) Are unable to walk.

7) Hypersensitivity to ibuprofen or a history of asthma, urticaria or allergic-type reactions after taking aspirin or other NSAID's

8) Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.

9) Have symptoms of dyspepsia or a history of uncomplicated peptic ulcer disease and are unable to add a proton pump inhibitor to their medication.

10) 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.

11) Have a history of hypersensitivity or allergy to beta-blockers,or a history of uncontrolled bronchial asthma or severe chronic obstructive pulmonary disease.

12) Patients on methotrexate.

13) Patients taking melatonin receptor agonists (such as RozeremŽ [ramelteon]).

14) 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.

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Links
Registration Number: NCT00625742
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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