FatiguePhase 1NCT02361125
Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate
A Phase 1 study testing Methylphenidate and Fatigue Evaluations in people with Fatigue, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Methylphenidate and Fatigue Evaluations
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2002to 28 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic.
- 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.
- Patient should describe fatigue as being present for a minimum of four days.
- 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.
- 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.
- Signed written informed consent.
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- Patient must be 18 years or older.The questionnaires used in this study have been validated only in the adult population.
- 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.
- 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.
Who cannot join
- Major contraindication to methylphenidate i.e. hypersensitivity
- Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Pregnant or lactating women. Childbearing age women are not on birth control.
- Patients taking MAO inhibitors, tricyclic antidepressants, clonidine, psychostimulants, concurrent steroids or other medications specifically for fatigue
- Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
- CAGE questionnaire score is 2 or above on a 0 to 4 scale.
- Patients with history of seizures or uncontrolled CNS disease, significant hepatic or renal dysfunction.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue
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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Methylphenidate, Fatigue Evaluations
- Keywords
- Fatigue, Cancer related fatigue, Methylphenidate, Methylphenidate Hydrochloride, Ritalin, Concerta, Fatigue evaluations
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Methylphenidate Hydrochloride, Ritalin, Concerta
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.
Fatigue EvaluationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | 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. Receives: Drug: Methylphenidate; Behavioral: Fatigue Evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Measurement on a 10-point scale
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start1 Aug 2002
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361125
- Sponsor's protocol ID
- ID02-166
- Other IDs
- NCI-2015-00623
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2015
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue
- ClinicalTrials.gov ID
- NCT02361125
- Acronym / sponsor ID
- ID02-166
- Conditions
- Fatigue
- Keywords
- Fatigue, Cancer related fatigue, Methylphenidate, Methylphenidate Hydrochloride, Ritalin, Concerta, Fatigue evaluations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2002 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate, Behavioral: Fatigue EvaluationsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic.
- 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.
- Patient should describe fatigue as being present for a minimum of four days.
- 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.
- 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.
Key exclusion criteria (8 listed)
- Major contraindication to methylphenidate i.e. hypersensitivity
- Currently on methylphenidate or has been on methylphenidate within the last 10 days.
- Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Pregnant or lactating women. Childbearing age women are not on birth control.
- Patients taking MAO inhibitors, tricyclic antidepressants, clonidine, psychostimulants, concurrent steroids or other medications specifically for fatigue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: Methylphenidate Hydrochloride, Ritalin, Concerta5 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. | Drug | Methylphenidate |
| Fatigue EvaluationsParticipants 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. | Behavioural | Methylphenidate |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylphenidate and Fatigue Evaluations in people with Fatigue, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Measurement on a 10-point scale (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.