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    Summary
    EudraCT Number:2015-000658-39
    Sponsor's Protocol Code Number:AkupresSNP
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-03-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2015-000658-39
    A.3Full title of the trial
    Randomized multicenter study of Acupressure combined with personalized antiemetics based on genetic variations (SNPs) in women undergoing neoadjuvant or adjuvant chemotherapy EC / FEC against breast cancer.
    Randomiserad multicenterstudie om Akupressur i kombination med individanpassad antiemetika baserat på genetiska variationer (SNP) hos kvinnor som genomgår neoadjuvant eller adjuvant kemoterapi EC/FEC mot bröstcancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anti nausea treatment based on individual genetic alterations (SNP) and simultaneous test of the validity of acupressure in conjuction with chemotherapy in women with breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    AkupresSNP
    A.4.1Sponsor's protocol code numberAkupresSNP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegion Jönköpings län
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCounty of Jönköping
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Jönköpings län
    B.5.2Functional name of contact pointDelmy Oliva
    B.5.3 Address:
    B.5.3.1Street AddressOnkologiska kliniken, Länssjukhuset Ryhov
    B.5.3.2Town/ cityJönköping
    B.5.3.3Post code55185
    B.5.3.4CountrySweden
    B.5.6E-maildelmy.oliva@rjl.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetamethasone
    D.3.9.1CAS number 378-44-9
    D.3.9.3Other descriptive nameBETAMETHASONE
    D.3.9.4EV Substance CodeSUB05797MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetamethasone
    D.3.9.1CAS number 378-44-9
    D.3.9.3Other descriptive nameBETAMETHASONE
    D.3.9.4EV Substance CodeSUB05797MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nausea in conjuction with neoadjuvant or adjuvant chemotherapy (FEC/EC) for patients with breast cancer.
    E.1.1.1Medical condition in easily understood language
    Nausea in conjuction with neoadjuvant or adjuvant chemotherapy (after surgery) for patients with breast cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The part study SNP based personalised antiemetic treatment (stopped 31 dec 2020):
    To study if patients, risk classified by SNP based risk assessment for chemotherapy induced nausea, treated with two different doses of corticosteroid (betamethasone) as part of the antiemetic treatment, receive the same antiemetic effect compared to patients treated with standard antiemetic treatment.

    The part study Acupressure (continues in 2021):
    To study if there is any difference in the antiemetic effect in patient’s treatment with acupressure compared to patients treated with placebo acupressure.
    E.2.2Secondary objectives of the trial
    In the part study SNP based personalised antiemetic treatment (stopped 31 dec 2020):

    Nausea in the acute and delayed time period.
    Intensity of nausea
    Frequency of vomiting.
    To compare a structured anamnesis on previous nausea experience to the SNP decided risk in terms of actual nausea
    To verify earlier found results, on relevant SNPs for the risk of nausea in a larger patient cohort.

    Secondary objectives part study acupressure (continues in 2021):.
    Nausea in the acute and delayed time period.
    Intensity of nausea
    Frequency of vomiting in the acute and delayed time period.
    Objective of both part studies. Differences in wellbeing and quality of life between the different treatment arms before and after 10 days after treatment with chemotherapy (according to the diary and EORTC QLQ-30)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Until 31 Dec 2020: Women with verified breast cancer planed for first neoadjuvant or adjuvant FEC/EC chemotherapy an
    Age ≥ 18 years
    From 2021:
    Patients with a cancer diagnosis that are planned for potentially emetogenic chemotherapy
    Knowledge of the Swedish language
    Informed consent in writing
    E.4Principal exclusion criteria
    ● Distant metastases in patients treated in an adjuvant setting
    ● Previous treatment with chemotherapy
    ● Unable to understand information about the study
    Only until 31 Dec 2020: Contra indication against betamethasone
    E.5 End points
    E.5.1Primary end point(s)
    Patient reported nausea defined as at least one occasion of nausea (light, medium or severe) according to the patient diary at any time during 10 days following chemotherapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During 10 days after initiation of treatment
    E.5.2Secondary end point(s)
    In both part studies:
    Acute nausea: Occurrence of at least one occasion of nausea (any grade) during the first 24 hours after chemotherapy
    Delayed nausea: Occurrence of at least one occasion of nausea (any grade) during 24 hours until 10 days after chemotherapy.
    Intensity of nausea: Occurrence of at least one occasion of intense nausea (VAS >/=5) during 10 days after chemotherapy.
    Vomiting frequency: Number of days with vomiting during 10 days after chemotherapy
    Well-being: According to the diary classified as very bad, bad, good or very good.
    Quality of Life: According to EORTC's scoring manual
    E.5.2.1Timepoint(s) of evaluation of this end point
    Acute nausea: during the first 24 hours after chemotherapy
    Delayed nausea: 24 hours until 10 days after chemotherapy.
    Intensity of nausea: At any time during 10 days after chemotherapy.
    Vomiting frequency: During 10 days after chemotherapy
    Well-being and quality of life will be evaluated before start of treatment and after 10 Days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The pharmaceutical part of the study is open but the acupressure is single blind.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 590
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state640
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 840
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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