Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years

Study Overview
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Brief Summary
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The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.

Official Title
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A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.

Conditions
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Breakthrough Pain, Cancer

Intervention / Treatment
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* Drug: Instanyl (Intranasal Fentanyl)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: decision to start treatment with intranasal fentanyl spray written informed consent Exclusion criteria: criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GENISIS<br> | Drug: Instanyl (Intranasal Fentanyl)<br>* This was an observational study. Therefore, the physician decided about dosage according to individual needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Instanyl | Initially prescribed dose/ most efficient single dose of Instanyl at study end | during therapy with Instanyl (planned: 28 days) | 
| Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination | Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme | before and after therapy with Instanyl (first/last visit) | 
| Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient | before and after therapy with Instanyl (first/last visit) | 
| Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit) | 5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all | after therapy with Instanyl (planned: 4 weeks) | 
| Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened | after therapy with Instanyl (at last visit) | 
| Physician: What is the Current Treatment Needs of Your Patient Regarding ... | Scale: 0=no, 1=low, 2=medium, 3=high | before and after therapy with Instanyl (first/last visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End | 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete | after therapy with Instanyl (planned: 4 weeks) | 
| Patient: How Many Episodes of Pain You Experience on Average? |  | initial visit (before start of therapy with Instanyl) | 
| Patient: Description of Pain at Initial Visit | 0=no pain, 10= most intense pain imaginable | initial visit (before start of therapy with Instanyl) | 
| Patient: How do You Feel Today? | Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good | before and after therapy with Instanyl (first/last visit) | 
| Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? | Scale: 0=not at all, 10=completely | before and after therapy with Instanyl (first/last visit) | 
| Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) | Scale: 0=no impairment, 70=complete impairment | before and after therapy with Instanyl (first/last visit) | 
| Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) | Scale: 0=complete impairment, 43=no impairment | before and after therapy with Instanyl (first/last visit) | 
| Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 | 0= conspicuous ≤20 1= inconspicuous >20 | before and after therapy with Instanyl (first/last visit) | 
| Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) | Scale: 0=worst, 5=best | before and after therapy with Instanyl (first/last visit) | 
| Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 | conspicuous score <1.5 inconspicuous score ≥1.5 | before and after therapy with Instanyl (first/last visit) | 
| Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End | 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete | after therapy with Instanyl (planned: 4 weeks) | 
| Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) | Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient | before and after therapy with Instanyl (first/last visit) | 
| Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) | 5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all | after therapy with Instanyl (planned: 4 weeks) | 
| Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) | Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened | after therapy with Instanyl (at last visit) | 
| Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End | 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete | after therapy with Instanyl (planned: 4 weeks) | 
| Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) | Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient | after therapy with Instanyl (first/last visit) | 
| Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) | Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened | after therapy with Instanyl (at last visit) | 
| Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... | Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more | after therapy with Instanyl (last visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal fentanyl spray