Clinical trial · Interventional
Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
Randomized Study Evaluating the Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients
NCT00273741CI-TRIAL-00002858RitalineterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulty of recrutement
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthenia | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylphenidate | Drug | — | UNRESOLVED |
| placebo comparator | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- methylphenidate 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
- interventionNames
- Drug: methylphenidate
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo capsules
- interventionNames
- Drug: placebo comparator
Primary outcomes (1)
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (5)
- BACKGROUNDBruera 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. PMID 1589233
- BACKGROUNDWilwerding 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. PMID 7539701
- BACKGROUNDRozans 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. PMID 11773187
- BACKGROUNDBruera 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. PMID 3791269
- BACKGROUNDBruera 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. PMID 14645434