Transcranial Direct-current Stimulation (tDCS) Efficacy in Refractory Cancer Pain.
- Conditions
- Cancer PainRefractory Pain
- Interventions
- Device: Sham Transcranial Direct Current StimulationDevice: Active Transcranial Direct Current Stimulation
- Registration Number
- NCT04683172
- Lead Sponsor
- Elsan
- Brief Summary
Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved. The 2010 INCA report showed that France is not an exception to this worldwide observation (synopsis of the 2010 national survey). This report shows that pain is the symptom that these patients fear the most and that it dramatically impacts their quality of life. These patients may experience nociceptive pain related to stimulation of sensory nerve endings by the tumour. When tumour resection is impossible, a symptomatic analgesic treatment is generally proposed, mainly consisting of administration of opioid analgesics. At high doses, this treatment induces adverse effects, especially drowsiness and psychomotor retardation that impair the patient's quality of life.
They may also experience neuropathic pain, secondary to anatomical lesions or functional impairment of nerve structures (peripheral nerves or cerebral or spinal tracts) related to repeated surgical procedures and/or radiotherapy. This type of pain may respond to antiepileptic or antidepressant drugs. At high doses, these treatments also induce adverse effects fairly similar to those observed during treatment of nociceptive pain. As these two types of treatment often need to be coprescribed, these patients frequently present an almost permanent state of drowsiness at the end of life, preventing all normal activities of daily living.
In recent years, noninvasive brain stimulation (NIBS) techniques (transcranial magnetic stimulation (rTMS) or transcranial direct-current stimulation (tDCS)) have been successfully used to treat chronic pain. It was shown that these NIBS techniques can improve pain in cancer patients in the palliative care setting.
- Detailed Description
tDCS appears to be more suitable than rTMS for the treatment of palliative care patients, who are often difficult to mobilize, as tDCS can be delivered at the patient's bedside and possibly even at home, which is not the case with rTMS. tDCS also appears to be rapidly effective (after 5 sessions) in the context of cancer pain, and this effect lasts longer than that of rTMS.
The proposed treatment of refractory cancer pain by tDCS in palliative care patients is a new treatment modality that is well adapted to hospitalised patients. Each patient will receive 20 minutes of transcranial direct-current stimulation daily for 5 consecutive days.
One arm will receive active stimulation and the control arm will receive sham stimulation. Patients and investigators will be blinded to the type of tDCS.
By improving the patient's activities of daily living, this treatment will enable the patient to return home under good conditions for both the patient and the caregivers. This treatment can also be continued at home. This strategy is consistent with current guidelines in this field, in which the priorities are improvement of quality of life, return home and decreased workload for caregivers.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham tDCS Sham Transcranial Direct Current Stimulation Sham tDCS will be delivered daily for 5 consecutive days with the patient either sitting or lying down.A tDCS session generally lasts 20 minutes. Active tDCS Active Transcranial Direct Current Stimulation Active tDCS will be delivered daily for 5 consecutive days with the patient either sitting or lying down.A tDCS session generally lasts 20 minutes.
- Primary Outcome Measures
Name Time Method Mean change in Pain Intensity on the Numerical Rating Scale Baseline up to Day 8 Pain intensity will be scored from 0 to 10 (0=No pain, 10 = worst pain) on the Numerical Rating Scale, 3 times daily. Mean variation of the pain NRS between the baseline assessment (Day -3 to Day -1) and the Day 8 assessment will be calculated and compared between arms.
- Secondary Outcome Measures
Name Time Method Effects of tDCS on anxiety Baseline up to Day 21 (State-Trait Anxiety Inventory (Form Y) (STAI-Y). Mean variations of scores will be compared between arms.
Immediate impact of each tDCS session on pain intensity Day 0 up to Day 4 Change in Pain Numerical Rating Scale score measured before and after each tDCS session.
Effects of tDCS on general symptoms Baseline up to Day 21 Edmonton Symptom Assessment System (ESAS). Mean variations of scores will be compared between arms.
Analgesic treatments consumption Baseline up to Day 8 Medication Quantification Scale (MQS). Mean variations of scores will be compared between arms.
Residual analgesic effect Baseline up to Day 21 Pain Numerical Rating Scale scores will be measured 3 times daily. Mean Numerical Rating Scale score will be calculated and compared between arms.
Effects of tDCS on pain Baseline up to Day 21 Brief Pain Inventory questionnaire, short form (BPI). Mean variations of scores will be compared between arms.
Response rate at the end of treatment Baseline up to Day 8 Efficacy of treatment, defined by a ≥ 20% reduction of the mean Numerical Rating Scale score between Baseline and Day 8.
Effects of tDCS on anxiety and depression Baseline up to Day 21 Hospital Anxiety and Depression Scale (HADS). Mean variations of scores will be compared between arms.
Trial Locations
- Locations (2)
Clinique Brétéché
🇫🇷Nantes, France
CHU Nantes
🇫🇷Nantes, France