Clinical trial · Interventional
Methylphenidate and a Nursing Telephone Intervention for Fatigue
A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients
NCT00424099CI-TRIAL-00066834completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylphenidate | Drug | — | UNRESOLVED |
| Non NTI | Behavioral | — | UNRESOLVED |
| Nursing Telephone Intervention | Behavioral | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1: Methylphenidate + NTI
- description
- Methylphenidate 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days + Nursing Telephone Intervention (NTI). NTI calls from study nurse 3 times weekly to ask about side effects and other symptoms.
- interventionNames
- Drug: Methylphenidate
- Behavioral: Nursing Telephone Intervention
- type
- PLACEBO_COMPARATOR
- label
- Group 2: Placebo + NTI
- description
- Placebo capsule orally as needed for 14 days + NTI, calls from study nurse 3 times weekly to ask about side effects and other symptoms.
- interventionNames
- Behavioral: Nursing Telephone Intervention
- Drug: Placebo
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients will be eligible to participate in this study if they have advanced cancer. 2. Patients will be eligible to participate in this study if they rate fatigue on the Edmonton Symptom Assessment System (ESAS) during the last 24 hours as greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue 3. Describe fatigue as being present every day for most of day for a minimum of 2 weeks 4. Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal 5. Are 18 years or older 6. Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment 7. Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number 8. Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia 9. Able to understand the description of the study and give written informed consent. 10. Able to understand the description of assessments, and able to complete baseline assessment 11. Patients on no erythropoietin or stable dose. Exclusion Criteria: 1. Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc. 2. Currently on methylphenidate or has been on methylphenidate within the last 10 days. 3. Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study 4. Major depression according to the Structured Clinical Interview (SCID) Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management 5. Pregnant or lactating women 6. Requirement for Monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or clonidine 7. Glaucoma, history of marked anxiety disorders 8. History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications. 9. Tourette's syndrome 10. Symptomatic tachycardia and uncontrolled hypertension. 11. Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). 12. Patients with pacemakers 13. Patients with symptomatic cardiac arrhythmias
References
Publications (2)
- DERIVEDYennurajalingam S, Tayjasanant S, Balachandran D, Padhye NS, Williams JL, Liu DD, Frisbee-Hume S, Bruera E. Association between Daytime Activity, Fatigue, Sleep, Anxiety, Depression, and Symptom Burden in Advanced Cancer Patients: A Preliminary Report. J Palliat Med. 2016 Aug;19(8):849-56. doi: 10.1089/jpm.2015.0276. Epub 2016 May 5. PMID 27148765
- DERIVEDBruera E, Yennurajalingam S, Palmer JL, Perez-Cruz PE, Frisbee-Hume S, Allo JA, Williams JL, Cohen MZ. Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: a randomized, placebo-controlled, phase II trial. J Clin Oncol. 2013 Jul 1;31(19):2421-7. doi: 10.1200/JCO.2012.45.3696. Epub 2013 May 20. PMID 23690414