Multimodal Treatment Strategy for Cancer Cachexia - Full Text View

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Exercise and Physical Fitness

Drug Information available for: Melatonin

U.S. FDA Resources

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

Primary Outcome Measures:

Participant Gain in Lean Body Mass [ Time Frame: Baseline, 15 days, and 29 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2008
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Multimodal Treatment Strategy 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 by mouth (PO) Daily Dietary Supplement: Juven 90 calories of Juven, twice a day.

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Eligibility

Ages Eligible for Study:	18 Years and older
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.
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
Have been taking corticosteroids for longer than 48 hours.
Have pulmonary edema, ascites or pitting edema on clinical examination.
Are unable to walk.
Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.
Have an ALT/AST>3x upper limit of normal.
Patients on methotrexate.
Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]).

Contacts and Locations

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

Egidio Del Fabbro, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00625742 History of Changes
Other Study ID Numbers:	2006-0739
Study First Received:	February 19, 2008
Last Updated:	September 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Cancer Cachexia
Cachexia
Melatonin

Juven
Exercise Training
Weight Loss

Additional relevant MeSH terms:

Cachexia
Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Melatonin

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012