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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Asthenia, Neoplasms

Intervention / Treatment
-----------------
* Drug: methylphenidate
* Drug: placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Drug: methylphenidate<br>* methylphenidate per os 20mg per day 7 days, 20mg or 40mg per day 7 days and 20, 40 or 60mg per day 14 days<br>* Other names: active;|
| Placebo Comparator: 2<br>placebo capsules | Drug: placebo comparator<br>* placebo capsules<br>* Other names: placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 7 days AVS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | each day | 
| Visual analogical scale of pain |  | inclusion, day 1, 2, 3, 7, 14 and 28 | 
| European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 |  | day 1, 7 and 28 | 
| Multidimensional Fatigue Inventory-20 (MFI-20) |  | day 1, 7, 14 and 28 | 
| Hospital Anxiety and Depression Scale (HADS) |  | inclusion, 7 and 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palliative care, methylphenidate