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    Summary
    EudraCT Number:2015-000604-25
    Sponsor's Protocol Code Number:R96-A6604-14-S22
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-10
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-000604-25
    A.3Full title of the trial
    HBOT LYCA: Hyperbaric Oxygen Therapy to reduce Lymphoedema after Breast Cancer - an explorative clinical trial
    HBOT LYCA: Hyperbar Oxygen Terapi for at reducere lymfødem efter bryst kræft - en eksplorativ undersøgelse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HBOT LYCA: exploring if pressurechamber treatment can reduce lymphoedema after breast cancer
    HBOT LYCA: kan trykkammer behandling reducere lymfødem efter brystkræft?
    A.3.2Name or abbreviated title of the trial where available
    HBOT LYCA
    A.4.1Sponsor's protocol code numberR96-A6604-14-S22
    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 SponsorDanish Cancer Society Research Center
    B.1.3.4CountryDenmark
    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 supportDanish Cancer Society Research Center
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointOle Hyldegaard
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535453545
    B.5.5Fax number4534454231
    B.5.6E-mailole.hyldegaard@regionh.dk
    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.2.1.1.1Trade name Conoxid 100%, Medicinsk Oxygen, Kryogen
    D.2.1.1.2Name of the Marketing Authorisation holderAGA A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.1Product nameMedicinal Oxygen
    D.3.4Pharmaceutical form Medicinal gas, cryogenic
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRespiratory use (Noncurrent)
    Inhalation use
    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 Yes
    D.3.11.13.1Other medicinal product typeoxygen
    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
    breast cancer related lymphedema
    brystkræftrelateret lymfødem
    E.1.1.1Medical condition in easily understood language
    swelling of the arm after breast cancer surgery
    hævelse i armen efter bryst kræft operation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    We investigate if women who have developed lymphoedema 1 year after surgery for breast ancer benefit from Hyperbaric Oxygen Treatment (HBOT) in terms of reduction of the arm volume.

    Vi undersøger om kvinder der har udviklet lymfødem et år efter operation for brystkræft kan have gavn af Hyperbar oxygen terapi for at reducere arm volumen.
    E.2.2Secondary objectives of the trial
    To examine if HBOT can increase the lymphatic clearance rate measured by lymphoscintigraphy, as well as psychological and physical function.
    At undersøge om Hyperbar Oxygen terapi jan forbedre lymfatisk drænage evne målt ved lymfesintigrafi, samt om det kan forbedre psykisk og fysisk funktion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants in LYCA EXERCISE with lymphoedema 12 months after surgery for breast cancer will be invited to participate. Lymphedema is present if a swelling of the arm on the operated side has persisted more than 4 weeks with a combined score of 2 points or more on NRS for symptoms, and a clinical exam reveals 2 or more of the following criteria to be present (i-iii are compared with the unaffected side):
    i. decreased visibility of subcutaneous veins on the ventral lower arm or dorsal hand
    ii. loss of normal contours in the region of the medial side of the elbow/distal end of the upper arm
    iii. thicker skin and subcutis on palpation
    iv. pitting oedema
    They must also be declared cancer free (before clinical mammography)
    Participants with lymphoedema 12 months after surgery for breast cancer will be invited to participate. Lymfødem er tilstede hvis en hævelse af armen i opererede side har varet i mere end 4 uiger med en kombineret score på mere end 2 på NRS for symptomer, og en klinisk undersøgelse afdækker 2 elelr flere af nedenstående kriterier som opfyldt: (i-iii sammenlignes med modsatte side):
    i. nedsat synlighed af subkutane vener på ventrale underarm eller dorsum af hånden
    ii. tab af normale konturer i mediale side af albue regionen/distale ende af overam
    iii. tykkere hud og subkutis ved palpation
    iv. pitting ødem
    I øvrigt skal de være erklæret cancer fri (inden klinisk mammografi)
    E.4Principal exclusion criteria
    Completed chemotherapy and radiotherapy less than 4 weeks ago
    pregnancy
    untreated severe heart failure detected during pre-examination for HBOT
    Undrained pneumothorax
    Unability to equalize pressure in the ears in spite of drain treatment by Ear- Nose- and Throat specialist.
    Intractable Claustrophobia non-responsive of standard pre-medication.
    Fuldført kemoterapi og/eller stråleterapi mindre end 4 uger siden
    graviditet
    ubehandlet svær hjertesvigt fundet ved forundersøgelse til HBOT
    udrænet pneumothorax
    ude af stand til at trykudligne i ørene trods drænanlæggelse ved øre-næse-hals specialist
    Klaustrofobi som ikke responderer til på normal pre-medicinering.
    E.5 End points
    E.5.1Primary end point(s)
    arm volume (perometry) and presence of lymphoedema by definiton of clinical criteria (2 of 4 clinical criteria fulfilled)
    Arm volumen (perometer) og tilstedeværelse af lymfødem med 2 ud af 4 kliniske kriterier opfyldt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    pre treatment day 1
    mid treatment day 20
    end treatment day 40
    3 month follow-up
    6 months follow-up
    opstart HBOT dag 1
    midt HBOT dag 20
    slut HBOT dag 40
    3 måneders follow-up
    6 måneders follow-up
    E.5.2Secondary end point(s)
    lymphatic clearance rate (lymphoscintigraphy)
    Bodycomposition and arm volume by Dual Energy X ray scan
    plasma Inflammatory biomarkers measured by blod samples (for biobank)
    Validated scales for physical and psychological function by self-report in questionnaires
    lymphatisk drænage evne (lymfeskintigrafi)
    kropssammensætning (DXA skanning)
    plasma inflammationsmarkører (blodprøver til biobank)
    validerede skalaer for psykisk og fysisk funktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    pre treatment day 1
    end treatment day 40
    6 months follow-up
    opstart HBOT dag 1
    slut HBOT dag 40
    6 måneders follow-up
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    en gruppe eksplorativ undersøgelse, semi-kontrolleret (kun til blodprøve sammenligning)
    one arm exploratory trial, semi-controlled (only for blood sample outcome)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sedvanlig behandling - lymfødemfrie patienter for normværdier i blodprøver
    usual care - lymphoedema free subjects for comparative norm-values of bloodsamples
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state25
    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
    Ingen
    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 Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-28
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