MDACC Study Summary 2006-0739

Study Summary
No. 2006-0739:.......Advanced Cancers......Egidio Del Fabbro......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2006-0739

Study Title:	An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia

Physician

New Patient Referral



Name:	Egidio Del Fabbro	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	792-6085 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Two return visits - day 15 (+/- 3 days) and day 29 (+/- 3 days).

Treatment Agents:	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:	Independent Multicenter Arrangements

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 melatonin, and Juven) can help to increase lean body mass (everything except fat) in cancer patients who experience cachexia.

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).

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).

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/18/2008

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	40

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.

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]).

Links

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