MDACC Study Summary 2005-0613

Study Summary
No. 2005-0613:.......Advanced Cancers......Eduardo Bruera......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2005-0613

Study Title:	A randomized controlled trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for fatigue in advanced cancer patients

Physician

New Patient Referral



Name:	Eduardo Bruera	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:	713-792-6085 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	1

Treatment Agents:	Methylphenidate IR	Home Care:	n/a

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 methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.

Study Objectives / Outcomes

1) Determine if methylphenidate 5 mg taken as needed is superior to placebo in the treatment of fatigue in advanced cancer patients as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale.

2) Secondary Objective-1: Determine if a nursing telephone intervention(NTI) improves fatigue (measured by the FACIT-F subscale) as compared to standard care in patients receiving Methylphenidate and placebo.

3) Secondary Objective-2: Investigate the additive or synergistic effect of Methylphenidate treatment plus NTI reduction of fatigue compared to either Methylphenidate treatment or NTI alone.

4) Secondary Objective-3: To investigate the additive or synergistic effect of Methylphenidate treatment plus Nursing Telephone Intervention (NTI) in the reduction of other associated symptoms such as depression, sleep, anxiety, and health related quality of life.

Study Status Information



Study Activation / Registration Date:	01/09/2007

IRB Review and Approval Date:	10/19/2005

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	212

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) Patients will be eligible to participate in this study if they have advanced cancer.

2) Patients will be eligible to participate in this study if they rate fatigue on the ESAS during the last 24h as greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue

3) Describe fatigue as being present every day for most of day for a minimum of 2 weeks

4) Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal

5) Are 18 years or older

6) Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment

7) Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number

8) Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemeglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia

9) Able to understand the description of the study and give written informed consent.

10) Able to understand the description of assessments, and able to complete baseline assessment

11) Patients on no erythropoietin or stable dose.

Exclusion Criteria:

1) Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc.

2) Currently on methylphenidate or has been on methylphenidate within the last 10 days.

3) Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study

4) Major depression according to the SCID DSM IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management

5) Pregnant or lactating women

6) Requirement for MAO inhibitors, tricyclic antidepressants or clonidine

7) Glaucoma, history of marked anxiety disorders

8) History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications.

9) Tourette's syndrome

10) Symptomatic tachycardia and uncontrolled hypertension.

11) Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantione, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine).

12) Patients with pacemakers

13) Patients with symptomatic cardiac arrhythmias

Links

Registration Number: NCT00424099
Study Information on Clinical Trials Registry (clinicaltrials.gov)