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

Conditions

Head and neck cancer

Brief summary

The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.

Detailed description

For the sensitivity analysis, the endpoint will be defined as the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. Pain will be assessed using a numerical scale. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures., Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014)., Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5., Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.

Related papers

No related papers found yet.

Interventions

DRUGLaroxyl 40 mg/mL

DRUGsolution buvable

DRUGQutenza 179 mg cutaneous patch

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.	—

Secondary

Measure	Time frame
For the sensitivity analysis, the endpoint will be defined as the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. Pain will be assessed using a numerical scale. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures., Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014)., Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5., Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.	—

Measure

Time frame

For the sensitivity analysis, the endpoint will be defined as the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. Pain will be assessed using a numerical scale. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures., Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014)., Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5., Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.

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Countries

France

Outcome results

None listed