Symptoms and General Pathology

All Conditions

Fatigue

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Nursing Telephone Intervention (NTI). NTI calls from study nurse 3 times weekly to ask about side effects and other symptoms.

Placebo capsule orally as needed for 14 days + NTI, calls from study nurse 3 times weekly to ask about side effects and other symptoms.

Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Non NTI, calls from research staff 3 times weekly.

Placebo capsules as needed with Non NTI, calls from research staff 3 times weekly.

5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.

Call from study nurse 3 times weekly to ask about side effects and other symptoms.

Nursing Telephone Intervention

One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.

Placebo

Non NTI are calls from research staff 3 times weekly.

Non NTI

Eduardo Bruera, MD

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.

Fatigue is one of the most common problems in patients with advanced cancer. Currently, there are no treatments for managing fatigue. Methylphenidate is a stimulant that increases ability to pay attention, increases mental alertness, and decreases feelings of fatigue.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to one of 4 groups. You will have an equal chance of being placed in any of the 4 groups. You, the medical staff, and researchers will not know to which group you have been assigned.

Regardless of which group you are in, you will record your fatigue in a daily diary at breakfast, lunch, dinner, and before bedtime. Based on your level of fatigue, you will take the study drug as needed. You can take the study drug every 2 hours but you may not take more than 4 capsules a day.

Participants in Group 1 will take a methylphenidate capsule by mouth as needed to relieve symptoms of fatigue for 14 days. A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse will set up a convenient time for you to take the phone call.

Participants in Group 2 will take a placebo capsule by mouth as needed for 14 days. A placebo is a capsule that does not contain any medication but looks just like the methylphenidate. A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse will set up a convenient time for you to take the phone call.

Participants in Group 3 will take a methylphenidate capsule by mouth as needed for 14 days. Participants in this group will not receive any calls from a study nurse. However, A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The research staff member will set up a convenient time for you to take the phone call.

Participants in Group 4 will take a placebo capsule by mouth as needed for 14 days. Participants in this group will not receive any calls from a study nurse. However, A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The research staff member will set up a convenient time for you to take the phone call.

You will be asked to wear a wrist actigraph monitor (a wristwatch that keeps track of your physical activity and your sleep cycles) for the first 14 days.

You will keep a daily diary of your fatigue and other symptoms, the number and times pills are taken, and your fatigue rating before and 2 hours after taking methylphenidate.

On about day 15 (or within 3 days) you will return to the palliative care clinic at M. D. Anderson for tests. You will be asked about your level of drowsiness, pain, constipation, and fatigue. You will be asked about any side effects you may have experienced and the effectiveness of the drug. You will repeat the 6 minute physical test, the cognitive status test, and you will return the actigraph monitor to the research nurse. You will also be given the option to receive up to 4 capsules of methylphenidate per day until Day 36. You will not be told whether you were taking placebo or methylphenidate during Days 1-14. If you cannot come to the clinic on Day 15, all tests except the walking test, may be performed over the telephone. You will be asked to mail the actigraph back.

If you decide not to take methylphenidate on Days 15-36, you will be considered off-study and you will have end-of-study tests on Day 15. If you decide to take methylphenidate on Days 15-36, you will remain on study until Day 36. On Day 36, you will have end-of-study tests.

For end-of-study tests, you will repeat the physical and cognitive tests. You will be asked about your symptoms and any side effects you may be experiencing. You will then return to your primary physician who will discuss with you whether or not to continue on the methylphenidate based on your response to the drug.

Your participation in this study should end on either Day 15 or Day 36. However, if you develop intolerable side effects (including fatigue) while on this study, the medication will be stopped and you will be removed from the study.

This is an investigational study. Methylphenidate has been approved by the FDA and is a commercially available drug. It is FDA approved at this dose level. Its use in this study, for this purpose, is investigational. About 212 patients will take part in this multicenter study. About 142 patients will be enrolled at The University of Texas (UT) MD Anderson.

Methylphenidate and a Nursing Telephone Intervention for Fatigue

A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients

FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores indicate higher fatigue. We measured the median change in FACIT-F fatigue sub scale score between Baseline and Day 15 using Kruskal-Wallis test.

The ESAS was used to assess the following 9 symptoms commonly experienced symptoms by cancer patients: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, and well-being. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 10 (0=not at all and 10=very much). Total ESAS fatigue score ranges from 0 to 10 with higher scores indicate higher fatigue. We measured the median change in ESAS fatigue score between Baseline and Day 15 using Kruskal-Wallis test.

National Institute of Nursing Research (NINR)

M.D. Anderson Cancer Center

Adverse Events data were presented in 2 arms. The reason is that only the Intervention medicine Methylphenidate (MP) can produce Adverse Events, not the telephone calls.

This is why the two Methylphenidate arms (MP+ NTI and MP+CTI) were combined into one arm and similarly the two Placebo arms were combined into one arm.

One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and NTI phone calls four to six times over the 2 weeks

Methylphenidate (MP) +Nursing Telephone Intervention (NTI)

One 5-mg Methylphenidate capsule was administered orally every 2 hours as needed up to 20 mg per day for 14 days and CTI phone calls four to six times over the 2 weeks

Methylphenidate (MP) +Control Telephone Intervention (CTI)

One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and NTI phone calls four to six times over the 2 weeks

Placebo (PL)+ Nursing Telephone Intervention (NTI)

One Placebo capsule was administered orally every 2 hours as needed up to four capsules per day for 14 days and CTI phone calls four to six times over the 2 weeks

Placebo (PL) + Control Telephone Intervention (CTI)

Methylphenidate (MP) + Nursing Telephone Intervention (NTI)

Methylphenidate (MP) + Control Telephone Intervention (CTI)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level.

Baseline Functional Assessment of Chronic Illness Therapy (FACIT-F ) Fatigue Subscale Score

The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level.

Baseline Edmonton Symptom Assessment System (ESAS) Fatigue Score

Analyses included all randomized participants

Dr. Eduardo Bruera, MD- Chair, Palliative Care Med

Those who completed intervention up to day 15

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Methylphenidate and a Nursing Telephone Intervention for Fatigue	NCT00424099	Advanced Cancer Fatigue	Methylphenidate Nursing Telepho... Placebo Non NTI	18 Years -	M.D. Anderson Cancer Center
Methylphenidate and a Nursing Telephone Intervention for Fatigue	NCT00424099	Advanced Cancer Fatigue	Methylphenidate Nursing Telepho... Placebo Non NTI	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for nursing telephone intervention