Cancer-related FatiguePhase 2/3EMFNCT00758407
Methylphenidate Treatment of Cancer-Related Fatigue
A Phase 2/3 study testing Methylphenidate hydrochloride in people with Cancer-related Fatigue, run by Medice Arzneimittel Pütter GmbH & Co KG at 6 sites in Germany.
Trial summary
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Methylphenidate hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 6 sitesGermany
- Study dates
- Aug 2006to Jan 2010
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- history of Cancer
- MFI >40
- Karnofsky Index >=70
- outpatient
- patient are able to give informed consent
Who cannot join
- treatment with psychostimulants in the past two weeks before screening
- active tumor disease
- depression (HADS >10)
- cachexia (BMI <18kg/m2)
- clinically relevant kidney disorders
- clinically relevant liver disorder
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- pathological ECG-finding
- high blood pressure
- occlusive arterial disease
- angina pectoris
- cardiac arrhythmias
- CHD
- post heart-attack status
- post stroke status
- known elevated intra-ocular pressure
- known enlarged prostates
- latent and manifest hyperthyreosis
- alcohol, medication or drug dependency in the past six months or manifest drug abuse
- participation in a clinical study within the past 30 days
- participation in this study at an earlier point in time
- simultaneous participation in another clinical trial
- women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
- pregnancy (positive pregnancy test) or lactation period
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Sonnenbergklinik
Bad Sooden-Allendorf
Dr. J.-U. Rüffer
Cologne
Praxis Dr. Lathan
Dortmund
Praxis Dr. Verpoort - Dr. Zeller
Hamburg
Medizinische Fakultät der Universität Leipzig
Leipzig
Medizinisches Versorgungszentrum - MOP
München
About this study
Official title: Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
- Conditions
- Cancer-related Fatigue
- Being tested
- Methylphenidate hydrochloride, Placebo
- Keywords
- Fatigue, Cancer, Methylphenidate,
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate hydrochlorideDrug
sustained release, dosage according to an individual titration schedule
PlaceboDrug
dosage according to an individual titration schedule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Methylphenidate hydrochloride |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
Measured: 6 weeks
Secondary outcomes (1)
Quality of Life (EORTC-QLQ C30)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2006
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manfred Heim, Prof., Principal investigator, Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758407
- Sponsor's protocol ID
- 6520-9959-02
- Acronym
- EMF
- Status last verified
- Jan 2010
- First submitted
- 24 Sep 2008
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT00758407
- Acronym / sponsor ID
- EMF / 6520-9959-02
- Conditions
- Cancer-related Fatigue
- Keywords
- Fatigue, Cancer, Methylphenidate,
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2010 (actual)
- First posted
- 25 Sep 2008 (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 purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Methylphenidate hydrochloride |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- history of Cancer
- MFI >40
- Karnofsky Index >=70
- outpatient
- patient are able to give informed consent
Key exclusion criteria (23 listed)
- treatment with psychostimulants in the past two weeks before screening
- active tumor disease
- depression (HADS >10)
- cachexia (BMI <18kg/m2)
- clinically relevant kidney disorders
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 |
|---|---|---|
| Methylphenidate hydrochloridesustained release, dosage according to an individual titration schedule | Drug | 1 |
| Placebodosage according to an individual titration schedule | Drug | 2 |
Primary outcome
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
Time frame: 6 weeks
1 secondary outcome
Quality of Life (EORTC-QLQ C30)
Time frame: 6 weeks
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 13 Jan 2010.
Related trials for Cancer-related Fatigue
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Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
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Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
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.
Manfred Heim, Prof. principal investigator
Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylphenidate hydrochloride in people with Cancer-related Fatigue, run by Medice Arzneimittel Pütter GmbH & Co KG at 6 sites in Germany.
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 5 inclusion and 23 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 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue) (time frame: 6 weeks). 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 13 Jan 2010.