Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain Clinical Trial
Official title:
Multicenter Randomized Open Trial to Evaluate Efficacy of Fentanyl Pectin Nasal Spray vs Physician Choice-Usual Care in Reducing Predictable Breakthrough Pain at Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy
The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.
Population: In and out patients with head and neck cancer undergoing radiotherapy,
regardless of the day of the radiotherapy treatment, with or without chemotherapy and taking
at least 60 mg of oral morphine daily or an equianalgesic dose of another opioid to control
background pain (background pain controlled is defined as NRS <4) but with uncontrolled pain
at swallowing (moderate/severe intensity: ≥ 4 on a NRS 0-10).
Study design: Patients that have signed the ICF and met inclusion and exclusion criteria are
randomly assigned 1:1 to receive one of the following predictable BTP at swallowing
treatments:
1. Fentanyl pectin nasal spray (FPNS)
2. Physician choice-Usual Care (PC-UC) Each patient will take the drug no more than 3
episode a day (at main meals: breakfast, lunch and dinner) for 15 episodes in total in
6 (-1, +2) consecutive days. At each episode the patients will record the pain at
baseline (before drug administration), and 10, 20 30 minutes after taking FPNS or
PC-UC.
At each meal, if the administered dose of FPNS or PC-UC is not adequately effective on pain
control, the patient is allowed to take a rescue medication of IRMS after 30 min from FPNS
or PC-UC administration.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention