Clinical trial NCT00516269
Conditions: Breast Cancer Fatigue Gastrointestinal Cancer
Keywords: Breast Cancer Gastrointestinal Cancer GI Cancer Fatigue OROS Methylphenidate HCl Methylphenidate Methylphenidate Hydrochloride Concerta Ritalin Placebo
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-08-01; Completion date: 2013-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed 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.

Arms: arm 1: Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks arm 2: Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
Interventions: intervention 1: Methylphenidate intervention 2: Placebo
Intervention descriptions: intervention 1: 18 mg by mouth daily for 2 weeks intervention 2: Capsule by mouth daily for 2 weeks

Protocol documents: