FatiguePhase 3NCT05041946
Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
A Phase 3 study testing Methylphenidate in people with Fatigue and Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2003to 19 Nov 2021
- Phase
- Phase 3
- 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
- Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
- Patients should describe fatigue as being present for a minimum of four days.
- If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
- No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
- Sign written informed consent.
- Patients must be 18 years or older.
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- Patient willing to keep a daily diary, engage in daily telephone follow up with a nurse, and after 7 days of treatment patient will return for a follow up visit.
- Patient must have telephone access to be contacted daily by the research nurse.
- 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, anxiety, tension, agitation, or motor tics
- 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.
- Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
- Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
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- CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
- History of Tourette's syndrome
- Patients with tachycardia and uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
Read the detailed description
Primary objective:
-To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score
Secondary objective
- To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life.
- To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety
- Being tested
- Methylphenidate, Placebo (Sugar Pill)
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Given PO
Placebo (Sugar Pill)Other
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | treatment of attention deficit disorder and narcolepsy (sleep disorder) Receives: Drug: Methylphenidate; Other: Placebo (Sugar Pill) |
| Placebo | Experimental | Sugar pill Receives: Drug: Methylphenidate; Other: Placebo (Sugar Pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start16 Jul 2003
- Primary completion15 Dec 2004
- Study completion19 Nov 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041946
- Sponsor's protocol ID
- 2003-0537
- Other IDs
- NCI-2021-10777
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05041946
- Acronym / sponsor ID
- 2003-0537
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Jul 2003 (actual)
- Primary completion
- 15 Dec 2004 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 13 Sep 2021 (actual)
- 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.
To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.
Detailed description
Primary objective:
-To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score
Secondary objective
- To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life.
- To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate, Other: Placebo (Sugar Pill)treatment of attention deficit disorder and narcolepsy (sleep disorder) |
| Placebo | Experimental | Drug: Methylphenidate, Other: Placebo (Sugar Pill)Sugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
- Patients should describe fatigue as being present for a minimum of four days.
- If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
- No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
- Sign written informed consent.
Key exclusion criteria (9 listed)
- Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics
- 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.
- Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
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 |
|---|---|---|
| MethylphenidateGiven PO | Drug | Methylphenidate, Placebo |
| Placebo (Sugar Pill)Given PO | Other | Methylphenidate, Placebo |
Primary outcome
To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale.
Time frame: through study completion, an average of 1 year
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 29 Sep 2022.
- M D Anderson Cancer CenterLink 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 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 3 study testing Methylphenidate in people with Fatigue and Cancer, 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 9 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 29 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To establish the effectiveness of patient the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score: 0-10 numerical scale. (time frame: through study completion, an average of 1 year). 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 29 Sep 2022.