A multicenter randomized open trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in reducing uncontrolled pain at swallowing (moderate/severe intensity) in patients with head and neck cancer undergoing radiotherapy.

Phase 1

Conditions: Patients with head and neck cancer undergoing radiotherapy with uncontrolled pain at swallowing (moderate/severe intensity).
MedDRA version: 16.0Level: LLTClassification code 10042648Term: Swallowing painfulSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-001271-20-IT

Lead Sponsor: . Molteni & C dei F.lli Alitti Società di Esercizio S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 158

Inclusion Criteria

1.Male and female aged 18 years or over
2.Diagnosis of stage III-IV cancer of oral cavity, oropharynx, hypopharynx, larynx, salivary gland cancer
3.Receiving radiation therapy (RT) with or without concurrent platinum based chemotherapy or cetuximab as first line treatment or as postoperative adjuvant treatment
4.Background pain managed with a stable fixed dose of opioid equivalent to 60mg oral morphine daily
5.Uncontrolled pain (IP-BTP) during swallowing with an intensity =4 on an 11-point numeric scale (0=no pain; 10=worst possible pain). This pain will have to be measured with the ingestion of a solid/liquid food (depending on the ability to swallow or less solid foods of the patient at moment)
6.Patients able to receive a nasal spray therapy
7.Willing and able to sign an informed consent form
8.Females with childbearing potential must provide a negative pregnancy test and both males and females must be using adequate contraception during the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

1.Patients with known metastatic disease.
2.Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications’ formulation ingredients.
3.Patients with impaired chemistry laboratory exams, assessed as routine clinical practice before radiotherapy start:
a.Hepatic function:
i.Total bilirubin > 2 times the upper-normal limit (ULN)
ii.Serum transaminase > 5 times ULN
b.Renal function:
i.Serum creatinine concentration > 2 times ULN
4.Pregnant or breastfeeding women.
5.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
6.Patients planned to receive other investigational treatments during study period
7.Patients with moderate to severe respiratory impairment