Know Cancer

forgot password

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

Phase 3
18 Years
75 Years
Not Enrolling
Asthenia, Neoplasms

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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)

Outcome Time Frame:

7 days AVS

Safety Issue:


Principal Investigator

Guillemette Laval, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Grenoble


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

DCIC 03 29



Start Date:

January 2007

Completion Date:

June 2009

Related Keywords:

  • Asthenia
  • Neoplasms
  • palliative care
  • methylphenidate
  • Asthenia
  • Neoplasms