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Strategy in which patient starts with amitriptyline

Strategy in which patient starts with pregabalin

strategy in which the patient starts with amitriptyline, during 8 weeks

amitriptyline

pregabalin

Yvonne Engels, PhD

Annelies Schalkwijk, MSc

Roberto Perez, PhD

Carin vd Rijt, MD, PhD

Kris Vissers, MD PhD FIPP

Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer pain, and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of a Dutch law (July 2007) about off-label medication prescription, off-label medication is not allowed anymore unless a standard or protocol exists. No clinical trials for this patient group have been published before.

Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as drug of first choice versus a strategy with pregabalin as drug of first choice.

Study design: An open label, randomised non-inferiority trial Study population: Incurable cancer patients with neuropathic pain Intervention: When a patient decides to take part in the study, he will be allocated randomly to one of the two study groups. A minimisation algorithm will be used, that balances for the cause of neuropathic pain (tumour related versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up procedure. Patients will be followed during 8 weeks.

Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill questionnaire, strategy success, costs per strategy, side effects, quality of life and concomitant analgesic drugs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are hardly any risks for the patients. The drugs in both arms already are usual care for the target population. If there is no or a too small effect, the drug of the other arm will be added, which strategy also is already usual care. All other medication, except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times during the study period. The patient had to fill in a pain diary daily (5 min), cost diary and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30 monthly (20 min).

Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer

A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective

Erasmus Medical Center

University of Amsterdam

Radboud University Medical Center

K.C.P. Vissers MD, PhD, FIPP

Neoplasms

Head and Neck Neoplasms

Pharmaceutical Solutions

Dermatologic Agents

Capsaicin

Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).

Capsaïcin patch (Qutenza®)

Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.

Amitriptyline (Laroxyl®)

Antoine BODEN

Thierry DELORME

Sylvie ROSTAING

Alix DOUSSET

Antoine BODEN, MD

This study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with head and neck cancer in remission and with sequelae neuropathic pain.

In this phase II trial, patients will be assigned in one of the two treatment arms:

* Arm A (Experimental arm): Capsaïcin patch (Qutenza®)
* Arm B (standard arm): Amitriptyline (Laroxyl®)

  130 patients will be included and will be followed during 9 months.

Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

Pain will be assessed using a numerical scale from 0 to 10.

Institut Claudius Regaud

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer	NCT00740571	Cancer Neuralgia	amitriptyline pregabalin	18 Years -	Radboud University Medical Center
Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.	NCT04704453	Head and Neck C...	Capsaïcin patch... Amitriptyline (...	18 Years -	Institut Claudius Regaud

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