Trial document




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  DRKS00009316

Trial Description

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Title

Non-intervention study to the capture of the quality of life with the adult patients who receive Akynzeo to the prevention from nausea and vomiting caused by highly or moderate emetogenic chemotherapy

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Trial Acronym

AkyPro NIS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Within the scope of this observational study data should be collected to the quality of life by the use of Akynzeo® as an antiemetic (drug that is effective against vomiting and nausea) medication in high or moderate emetogenic (capacity to induce vomiting) chemotherapy. The data to the quality of life will be collected by means of FLIE questionnaire (standardized questionnaire to vomiting and nausea).
The duration of the documentation of each patient will take 3 sequent chemotherapy cycles.
Akynzeo® is a combination of both substances Netupitant and Palonosetron that has demonstrably better prevented or decreased vomiting and nausea in approval studies than available drugs. Palonosetron has been successfully used for a long time. Nevertheless still some of the patients lack prevention of nausea and vomiting caused by chemotherapie. The combination of Palonosetron with the new substance Netupitant can improve the situation of affected patients. There were no significant complications related to the use of Akynzeo® in approval studies.

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Brief Summary in Scientific Language

Rationale: Aim of this non-interventional study is to survey the quality of life when using Akynzeo® to prevention from chemotherapy induced nausea and vomiting (CINV).
Indication: Patients with CINV who receive maximum 2-day high or moderate emetogenic chemotherapy due to different tumor entities, e. g.:
1. 1-day chemotherapy
2. 2-day chemotherapy
Patient Population: In current NIS are to enroll patients with gynaecological cancers and other strong and / or hemotological tumor diseases.
Treatment: Patients will be treated according to the summary of product characteristics Akynzeo®.
The data on quality of life will be collected by means of FLIE questionnaire when administering Akynzeo® at high or moderate emetogenic chemotherapy.
Collecting safety data and information about adverse events related to the administration of Akynzeo®. Furthermore it is to collect in the patient diary the response to the Akynzeo® (complete symptom control) and need for administration of a rescue medication. Medicinal products used as rescue medication are to be collected.
Documentation will be done within 3 sequent chemotherapy cycles.
Statistical aspects: The evaluation of collected parameters will be analysed with descriptive statistics.
The severity level, absolute and relative frequencies of all adverse events will be represented.
Prospective stratification by 1-day-chemotherapy and 2-day-chemotherapy as well as by high or moderate emetogenic chemotherapy

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Organizational Data

  •   DRKS00009316
  •   2015/10/20
  •   [---]*
  •   no
  •   Approved
  •   Eth-43/15, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   R11 -  Nausea and vomiting
  •   chemotherapy induced nausea and vomiting
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Interventions/Observational Groups

  •   The patients will be observed and documented for a period of 3 chemotherapeutic cycles. Data about the quality of life will be collected by using the FLIE-questionnaire (standardised questionnaire about nausea and vomiting) and a patient diary needs to be kept by the patients.

    About the taking of Akynzeo:
    Dosage - each capsule contains 300 mg of Netupitant and 0,5 mg of Palonosetron.
    Application - hard capsule to take oraly; the capsule needs to be swallowed in toto.
    Dosing regimen: one capsule of 300 mg/0,5 mg needs to be taken about one hour before beginning of each chemotherapy cycle (always on day 1 of each cycle).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

quality of life by means of FLIE questionnaires
(The recording of the questionnaires by the study participants is done respectively on day 5 or 6 after medication with Akynzeo(R). The questionnaires will be filled in on three consecutive medications with Akynzeo(R).)

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Secondary Outcome

• complete response (no vomiting, no rescue medication) by eCRF & Patient Diary
• kind of additional medication
• safety data and AE

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2015/10/07
  •   2500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Signed patient consent form
• Age: ≥ 18 Years
• 1- or 2-day chemotherapy, high or moderate emetogen
• anti-emetic prevention with Akynzeo® according to the summary of product characteristics

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Exclusion Criteria

• Patients without chemotherapy
• radiotherapy alone
• brain tumour, symptomatic brain metastases
• anticipatory nausea and vomiting
• not chemotherapy-induced nausea and vomiting on the basis of other disorders or drugs
• chemotherapies that last more than 2 days within a chemotherapy cycle
• pregnancy
• hypersensitivity to the active substances, excipient or other constituent materials of Akynzeo®

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Addresses

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    • RIEMSER Pharma GmbH
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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    • ONKODATAMED GmbH
    • Mr.  Dr. med.  Jörg  Schilling 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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    • ONKODATAMED GmbH
    • Ms.  Anna  Merk 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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    • RIEMSER Pharma GmbH
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.