Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients

Phase

Condition

Breast Cancer

Pain (Pediatric)

Gastric Ulcers

Treatment

N/A

Clinical Study ID

NCT00516269

ID00-372

Ages > 18
All Genders

Study Summary

The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug will also be studied. Another goal of the study is to see how certain cytokines change while patients undergo chemotherapy or hormonal treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancerundergoing chemotherapy or hormonal treatment
Patient is > or = 18 years of age
Patient has Brief Fatigue Inventory "fatigue worst" score of > or = 4 at baseline
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline
Patient has a life expectancy > or = 6 months from the start of the study
Patient is using acceptable birth control methods. Female participants (if of childbearing potential and sexually active) and male participants (if sexually active witha partner of child-bearing potential) must use medically acceptable methods of birthcontrol. Medically acceptable methods of contraception include abstinence, birthcontrol pills, diaphragm with spermicide, condom with foam or spermicide, vaginalspermicidal suppository or surgical sterilization
Patient must speak and understand English
Patient has provided written informed consent to participate in the study prior toenrollment to the study

Exclusion

Exclusion Criteria:

History of hypersensitivity reaction to methylphenidate
History of or current seizure disorder, glaucoma, major psychiatric diagnosis,narcolepsy, Tourette's syndrome, tension or agitation
History of clinically significant cardiac disease.
Uncontrolled hypertension: has not been on a stable treatment dose for the past month,or has a systolic pressure consistently (defined as 3 consecutive blood pressurereadings within the last 30 days) greater than 150 mm Hg or diastolic pressureconsistently greater than 85 mm Hg
History of fibromyalgia
Use of alcohol while participating in the study
Current use of illicit drugs or history of alcohol or drug abuse and/or abusepotential (see protocol for criteria)
Moderate to severe depression (> or = 20 on Beck Depression Index II)
If taking antidepressants, no changes in dose and/or no start of new course oftreatment in the last 30 days
Currently taking psychostimulants (including appetite suppressants), monoamine oxidase (MAO) inhibitors, anticoagulant or anticonvulsant therapy
Current use of corticosteroids, medications, or stimulants (i.e., vivarin) used toimprove fatigue symptoms
Use of an investigational medication within the past month
Current use of the following herbals or supplements for fatigue relief (DHEA, SAME,ginkgo, ginseng, St. John's Wort (including DHEA, SAME, ginkgo, ginseng, St. John'sWort, metabolite, effedrin, basil, citronella, fennel, horseradish roots, lavenderflowers, lemon verbena, marjoram, mint, nettle, pine needles, rosemary, sage, savory,thyme, bay, cayenne pepper, cinnamon, eucalyptus, hyssop, myrrh, oregano, peppermint,ginseng, green, black or Chinese tea, ephedra (aka - ma-huang), popotillo, and Mormontea)
Any coexisting medical condition or are taking any concomitant medication that islikely to interfere with the safe administration of methylphenidate
Patients who start epoetin within 30 days prior to enrollment
Patients who start taking epoetin during the first week of the study
Hemoglobin < 8.0 gm/dl
Patients with a thyroid-stimulating hormone (TSH) value > or = 1.5 times the upperlimit of normal (ULN)
Albumin value 50% lower than the lower limit of normal
Evidence of hepatic impairment [total bilirubin > or = 2.5 times ULN (normal range of 0 - 1.0 mg/dl, serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)]
Evidence of renal impairment (serum creatinine > 2.5 times ULN, normal range of 0.8 - 1.5 mg/dl)
A severe narrowing (pathological or iatrogenic), obstruction of the gastrointestinaltract, or gastrointestinal malabsorption
If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of newcourse of treatment in the last 30 days
Patients with nausea, vomiting, or diarrhea of Common Toxicity Criteria for AdverseEffects (CTCAE) grade III or higher
If taking anticonvulsants for sensory neuropathy (Gabapentin or Pregabalin), nochanges in dose and/or no start of new course of treatment in the last 30 days
History of severe headaches within 30 days prior to enrollment

Study Design

August 01, 2004

December 31, 2013

Study Description

OROS Methylphenidate HCl is a mild central nervous system stimulant. Cytokines are a type of protein found in blood. Medical researchers here at M. D. Anderson are working to see if they are related to, or can tell us something about, fatigue and its symptoms.

This study will be divided into two, 14-day periods. During one of the 14-day periods, you will be given the study drug. During the other period, you will be given a placebo. A placebo is a sugar tablet that looks just like the study drug tablet.

You will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. In one group you will receive the study drug first and the placebo second. In the other group you receive the placebo first and the study drug second. The chance of being in either treatment group is about equal. Neither you nor the research staff will know which treatment order you are assigned to.

Before treatment starts, you will fill out questionnaires about your level of fatigue, distress, symptoms, and general health. It should take about 5 minutes to complete the questionnaires. You will have a medical history, physical exam (with pulse, temperature, blood pressure), and blood work done. At the start of the study a test of the heart called an EKG will be done. At the start of the study, and after you finish the study, you will complete additional questionnaires that measure mood, fatigue, sleep, and appetite. It should take about 15 minutes to complete the questionnaires. You will also complete a series of tests for memory, visual-motor, and thinking functions. These tests should take about 30 minutes to complete. (This evaluation may take place on or before Day 1 of the study.)

On Day 1, a set of study medications and a diary will be given to you. For the first fourteen days of the study, you will take the assigned study medication (either drug or placebo). Everyday you will fill out the diary, noting the time you took the study medication and answering two questions about your fatigue.

On Day 7, study personnel will see you in the clinic or Ambulatory Treatment Center. The delegated research personnel will take your blood pressure and pulse and ask you about any symptoms or complaints you may have had or any medications you may have taken.

On Day 14, study personnel will see you in the clinic or the Ambulatory Treatment Center where blood pressure and pulse will be measured. Unused study medication will be returned and your diary will be reviewed with the delegated research personnel. You will complete questionnaires asking about fatigue, sleep, depression, and symptoms. It should take about 15 minutes to complete them. You will also complete a series of tests for memory, visual-motor, and thinking functions. The tests should take about 30 minutes to complete. A blood draw will be done to look for changes in hemoglobin and for cytokine analysis.

A new set of study medications and a diary will be given to you. You will follow the same instructions as the first time period. You will take the assigned study medication every morning and fill out the diary, noting the time you took the study medication and answering two questions about your fatigue.

On Day 21, the same activities as Day 7 will occur.

If you are not scheduled to come to M. D. Anderson on Day 7 and Day 21, you will take 2 separate blood pressure measurements 5 minutes apart for each day and report results within 24 hours to the research staff. If you choose to take your blood pressure measurements at home, you need to bring your monitor at study enrollment to have measurements double-checked by research staff.

On Day 28, the study will end. The same activities as Day 14 will occur. In addition, you will have a physical exam.

You will be asked if you prefer the first (first 2 weeks of study) or second (second 2 weeks of study) treatment phase. If you want to continue taking the OROS Methylphenidate you will be allowed to do so off-study as long as there are no medical reasons not to.

This is an investigational study. The study drug has been approved for attention-deficit hyperactivity disorder but is investigational as a treatment for cancer related fatigue. The study medication and physical exams will cost you nothing. You will be reimbursed with a fixed amount of money for each scheduled study visit. The payment will be in the form of a gift card for parking expenses and a gift card for gas expenses. The study doctor or study staff can tell you more about when you will be able to receive reimbursement. A total of 50 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson.

Connect with a study center

UT MD Anderson Cancer Center
Houston, Texas 77030
United States
Site Not Available

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