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Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02361125
Recruitment Status : Active, not recruiting
First Posted : February 11, 2015
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to evaluate the effectiveness of ritalin (methylphenidate) taken on an as needed basis for the management of cancer related fatigue. The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers will also evaluate the level of fatigue throughout the day and any possible causes of fatigue.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Methylphenidate Behavioral: Fatigue Evaluations Phase 1

Detailed Description:

Fatigue is a major problem in cancer patients. Methylphenidate is a drug currently FDA approved for the treatment of attention deficit disorder and narcolepsy (sleep disorder). Methylphenidate has shown a benefit in improving thinking and decreasing drowsiness and pain in cancer patients taking opioids (pain killers). Methylphenidate has also shown a rapid response in treating depression.

Participants in this study will at first have an evaluation of their fatigue, ability to sleep, and they will answer a set of general symptom questions. It will take about 20 minutes to complete the evaluation. Participants will have a blood test called TSH (thyroid-stimulating hormone) performed to rule out the possibility of thyroid dysfunction as cause of fatigue.

The study will last for 7 days. Participants will be able to take up to four methylphenidate tablets a day on an as needed basis for fatigue. Participants will keep a daily diary where they will record their fatigue rating (0-10) before and 2 hours after taking methylphenidate. The research nurse will contact participants daily by phone (in person for in-patients) to make sure the daily diary is being filled out, to ask about side effects of treatment, and to ask participants to rate their fatigue at four times during the past day and about any possible causes of fatigue.

On the 7th day of treatment, participants will be evaluated in the palliative care clinic or by telephone. Evaluation of fatigue, ability to sleep, and general symptoms along with an evaluation of side effects and effectiveness of methylphenidate will be performed. The evaluation will take about 15 minutes to complete. If participants develop intolerable side effects while on study, the medication will be stopped and they will be removed from the study.

If participants find the drug beneficial and wish to continue taking it, they will be given a prescription for methylphenidate and can be followed as an outpatient in the palliative care clinic. Participants who choose to continue the medication will be evaluated at the end of 4 weeks for fatigue, ability to sleep, and general symptoms along with an evaluation of side effects and effectiveness by phone or in the clinic. The evaluation will take about 15 minutes to complete.

This is an investigational study. The use methylphenidate is investigational. A total of 36 patients will take part in this study. All will be enrolled at UTMDACC.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue
Actual Study Start Date : August 1, 2002
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Methylphenidate

Participants given a 7 day supply of 5 mg methylphenidate tablets (to take a maximum of 20 mg/day, for total of 28 tablets). Directions for use are to take one 5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue (maximum of 4 tablets/day).

Evaluation of fatigue, ability to sleep, and general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.

Drug: Methylphenidate
5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue. Participants to take a maximum of 20 mg/day, for total of 28 tablets for 7 days.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta

Behavioral: Fatigue Evaluations
Participants to have evaluation of their fatigue, ability to sleep, and will answer a set of general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.




Primary Outcome Measures :
  1. Fatigue Measurement on a 10-point scale [ Time Frame: 7 days ]
    Primary endpoint is fatigue as measured on a 10-point scale. An average 2-point reduction in fatigue from before to 2 hours after taking methylphenidate considered a clinical success.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic.
  2. Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale on which 0 equals no fatigue and 10 worst possible fatigue.
  3. Patient should describe fatigue as being present for a minimum of four days.
  4. If patients are on opioids for the treatment of cancer pain, they must have had no dose changes (>25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed.
  5. Presence of relatively intact cognition defined by normal Mini Mental State Questionnaire according to age and education level. A score of 24 or above is usually considered normal.
  6. Signed written informed consent.
  7. Patient must be 18 years or older.The questionnaires used in this study have been validated only in the adult population.
  8. Patient willing to keep a daily fatigue diary, engage in daily telephone follow up with a nurse and after 7 days of treatment either return for a follow up visit or this can be done over the telephone.
  9. Hemoglobin of >/=10 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.

Exclusion Criteria:

  1. Major contraindication to methylphenidate i.e. hypersensitivity
  2. Currently on methylphenidate or has been on methylphenidate within the last 10 days.
  3. Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
  4. Pregnant or lactating women. Childbearing age women are not on birth control.
  5. Patients taking MAO inhibitors, tricyclic antidepressants, clonidine, psychostimulants, concurrent steroids or other medications specifically for fatigue
  6. Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
  7. CAGE questionnaire score is 2 or above on a 0 to 4 scale.
  8. Patients with history of seizures or uncontrolled CNS disease, significant hepatic or renal dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361125


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Eduardo Bruera, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02361125     History of Changes
Other Study ID Numbers: ID02-166
NCI-2015-00623 ( Registry Identifier: NCI CTRP )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Fatigue
Cancer related fatigue
Methylphenidate
Methylphenidate Hydrochloride
Ritalin
Concerta
Fatigue evaluations
Additional relevant MeSH terms:
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Methylphenidate
Fatigue
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents