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AstheniaPhase 3RitalineNCT00273741

Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients

A Phase 3 study testing methylphenidate in people with Asthenia and Neoplasms, run by University Hospital, Grenoble at 13 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in palliative care, i.e. with a progressive or terminal disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthenia, Neoplasms
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
39 participants
Where
13 sitesFrance
Study dates
Jan 2007to Jun 2009
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced phase of neoplasm without any treatment available.
  • Life expectancy of more than 1 month
  • Karnofsky index more than 50%
  • Chemotherapy IV or immunotherapy SC stopped more than 3 weeks before the end of the study
  • Asthenia more than 5/10 on the visual analogical scale
  • Informed consent form signed
  • Affiliation to social security

Who cannot join

  • Patients who can receive chemotherapy IV or immunotherapy SC in the month following the study
  • Patients in whom disease can respond to chemotherapy
  • Corticotherapy started less than 7 days before the study or potentially within the first week of the study
  • Asthenia which can be easily corrected
  • Contraindications to the amphetamines
  • HADS score of anxiety and/or depression more than or egal to 17/21
Show all 10Show fewer
  • Potential surgery with general anesthesia in the first 7 days of the study
  • Inability to quantify the sensation of asthenia on the visual analogical scale
  • Pregnancy or feeding
  • Guardianship

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Hôpital D'Annemasse

    Annemasse, 74107

  • Centre Régional d'Accompagnement et de Soins Palliatifs,

    Bordeaux, 33000

  • Equipe mobile de recherche et de soutien en soins pallitaifs

    Grenoble, 38043

  • Unité de Soins palliatif, Centre Oscar Lambret

    Lille, 59000

  • Unité de Soins Palliatifs, Hôpital Lyon sud

    Lyon, 69000

  • Soins Palliatifs et Soins de support, Centre Léon Bérard, 28 rue Laënnec,

    Lyon, 69373

  • Unité mobile de soutien et de soins palliatifs, Hôpital Saint-Eloi

    Montpellier, 34295

  • EMSP, Institut Curie

    Paris, 75005

  • EMSP, hôpital Saint aAntoine

    Paris, 75012

  • Praz-Coutant

    Passy, 74190

  • Unité de Soins Palliatifs

    Saint-Etienne, 42055

  • EMSP, Hôpitaux du Léman

    Thonon-les-Bains, 74203

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients

The aim/objective of this study is to evaluate the antiasthenic effect of methylphenidate with a visual analogical scale (VAS) after 7 days of treatment, in cancer patients, in palliative care, i.e. with a progressive or terminal disease.

Read the detailed description

Cancer patients in an advanced phase or who are terminally ill generally present with depression, pain, drowsiness, alterations of cognition, anorexia and other symptoms due to the progressive disease. The objective of the medical team of support and palliative care is to control these effects to maintain a quality of life. Particularly, the cancer patient in an advanced phase of the disease presents with important asthenia. In some patients, this asthenia is characterized by drowsiness or apathy. It always leads to ill-being and a sensation of bad adaptation. When an etiologic treatment is possible (correction of the anaemia, of the metabolic disorders, of the undernutrition, of the anorexia, of the insomnia, of the stubborn pain, of the psychological suffering), the asthenia can be fought. But, when it appears in patients not really in the end of life (life expectancy more than 1 month) and when no etiologic treatments are possible, other solutions must be considered, and all the more when the complaint is important with repeated requests for relief.

Methylphenidate is an amphetamine first indicated for deficient attention disorders with hyperactivity in children more than 6 years old. Several studies have been realized to evaluate its effect in cancer patients in palliative care. Some studies showed, in particular, its effectiveness on asthenia because of a stimulant and an antidepressant action. The methylphenidate could have an anti-analgesic effect or co-analgesic effect. All these studies are observational and not randomized. So they have a small level of proof and they have not been realized in a population of asthenic patients in palliative care. So a randomized controlled clinical trial in this specific population needs to be experimented.

Conditions
Asthenia, Neoplasms
Being tested
methylphenidate, placebo comparator
Keywords
palliative care, methylphenidate
Medical subject headings
Asthenia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylphenidateDrug

    Also called active

    methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days

  • placebo comparatorDrug

    Also called placebo

    placebo capsules

Study groups in NCT00273741
Study groupRoleWhat they receive
1Experimentalmethylphenidate at 20mg per day during 7 days, at 20mg or 40mg per day during 7 days and 20, 40 or 60mg per day during 14 days
Receives: Drug: methylphenidate
2Placebo comparatorplacebo capsules
Receives: Drug: placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of 3 units between the two study groups of the subjective impression of asthenia measured at the first day before the beginning of the treatment with a visual analogical scale at day 7 (+/- 1 day)

    Measured: 7 days AVS

Secondary outcomes (5)

  1. Adverse events

    Measured: each day

  2. Visual analogical scale of pain

    Measured: inclusion, day 1, 2, 3, 7, 14 and 28

  3. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

    Measured: day 1, 7 and 28

  4. Multidimensional Fatigue Inventory-20 (MFI-20)

    Measured: day 1, 7, 14 and 28

  5. Hospital Anxiety and Depression Scale (HADS)

    Measured: inclusion, 7 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Why it stopped: difficulty of recrutement

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273741
Sponsor's protocol ID
DCIC 03 29
Acronym
Ritaline
Status last verified
Dec 2009
First submitted
6 Jan 2006
Last updated
7 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Bruera E, Miller MJ, Macmillan K, Kuehn N. Neuropsychological effects of methylphenidate in patients receiving a continuous infusion of narcotics for cancer pain. Pain. 1992 Feb;48(2):163-166. doi: 10.1016/0304-3959(92)90053-E.

    PubMed 1589233

  • Wilwerding MB, Loprinzi CL, Mailliard JA, O'Fallon JR, Miser AW, van Haelst C, Barton DL, Foley JF, Athmann LM. A randomized, crossover evaluation of methylphenidate in cancer patients receiving strong narcotics. Support Care Cancer. 1995 Mar;3(2):135-8. doi: 10.1007/BF00365854.

    PubMed 7539701

  • Rozans M, Dreisbach A, Lertora JJ, Kahn MJ. Palliative uses of methylphenidate in patients with cancer: a review. J Clin Oncol. 2002 Jan 1;20(1):335-9. doi: 10.1200/JCO.2002.20.1.335.

    PubMed 11773187

  • Bruera E, Chadwick S, Brenneis C, Hanson J, MacDonald RN. Methylphenidate associated with narcotics for the treatment of cancer pain. Cancer Treat Rep. 1987 Jan;71(1):67-70.

    PubMed 3791269

  • Bruera E, Driver L, Barnes EA, Willey J, Shen L, Palmer JL, Escalante C. Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. J Clin Oncol. 2003 Dec 1;21(23):4439-43. doi: 10.1200/JCO.2003.06.156.

    PubMed 14645434

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing methylphenidate in people with Asthenia and Neoplasms, run by University Hospital, Grenoble at 13 sites in France.

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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. 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 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 was stopped early (reason given: difficulty of recrutement). Results are not available in the source record.

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?

Reduction of 3 units between the two study groups of the subjective impression of asthenia measured at the first day before the beginning of the treatment with a visual analogical scale at day 7 (+/- 1 day) (time frame: 7 days AVS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00273741, which also lists 5 linked publications.

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 7 Dec 2009.

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