{ "FullStudy":{ "Rank":218058, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513278", "OrgStudyIdInfo":{ "OrgStudyId":"APN201-1-01" }, "Organization":{ "OrgFullName":"Apeiron Biologics", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of APN201 (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer", "OfficialTitle":"Randomized, Double-blind, Split-body, Placebo-controlled Phase Ib Study of APN201 (Liposomal Recombinant Human Cu/Zn-superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer" }, "StatusModule":{ "StatusVerifiedDate":"July 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 14, 2011", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 12, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 15, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Apeiron Biologics", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The standard treatment for early-stage breast cancer is breast-conserving surgery followed by adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates with a good cosmesis and provides an effective alternative to mastectomy. However, in most women receiving radiotherapy radiation dermatitis occur to some degree.\n\nRadiation dermatitis generally manifests within a few weeks after the start of radiation therapy. Its onset varies depending on the radiation dose intensity and the normal tissue sensitivity of individuals. As the cumulative dose of radiation increases the transient erythema occurring during the first weeks of radiotherapy may evolve into the more persistent erythema and to dry or even moist desquamation that reflects the damage to the basal cell layer and the sweat and sebaceous glands.\n\nThere is currently no evidence that prophylactic treatments, beyond keeping the irradiated area clean and dry, are effective in reducing the incidence or severity of radiation dermatitis (Bolderston et al. 2006).\n\nHowever, together with other enzymes of the peroxidase pathway, SOD scavenges the superoxide, hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al. 1983). In physiological conditions, the production of free radicals (Monte & Sacerdote 1994) and the action of antiradicals' enzymes is balanced. Following tissue injuries, either pathological or caused by agents such as radiation therapy, an excess production of free radicals is observed (Petkau 1986; Lorette & Machet 2001). Furthermore, basal SOD is increased in breast cancer patients before radiation therapy as compared to controls (Seth et al. 2003), and decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD applied during radiotherapy could be used to prevent the effects of free radicals and thus might protect the patient's skin from radiation-induced skin reactions.\n\nTREATMENT PLAN All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201, the other area is treated with placebo in a double-blind fashion.\n\nStudy treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively) (see schedule of assessments, section 5.1).\n\nStudy treatment is stopped if radiation dermatitis of ≥ grade 2 occurs in one or both treated areas for ≥ 3 days AND a difference in the severity of radiation dermatitis of ≥ 1 grade is seen between the two treated areas. From that point in time the patient only receives the treatment that appeared to be beneficial and this treatment is applied to the whole irradiated region until completion of the 25th, respectively 28th, fraction.\n\nTreatment stops earlier in case of progressive disease or unacceptable toxicity or intolerability." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Radiation Induced Dermatitis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"20", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Control arm", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201, the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: APN201", "Drug: Placebo" ] } },{ "ArmGroupLabel":"APN201", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: APN201" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"APN201", "InterventionDescription":"All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel; 1.6 mg rhSOD per mL), the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.\n\nStudy treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively). Study treatment is applied as a thin film on the irradiated area ≥10 minutes each day before radiation therapy (approximately 1 mL APN201 per 100 cm2 of the radiation field size and approximately 1 ml placebo per 100 cm2 of the radiation field size).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "APN201", "Control arm" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel; 1.6 mg rhSOD per mL), the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.\n\nStudy treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively). Study treatment is applied as a thin film on the irradiated area ≥10 minutes each day before radiation therapy (approximately 1 mL APN201 per 100 cm2 of the radiation field size and approximately 1 ml placebo per 100 cm2 of the radiation field size).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Control arm" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"To evaluate safety and tolerability of APN201", "PrimaryOutcomeDescription":"Adverse events, vital signs and laboratory assessments (hematology, serum chemistry) are used for safety evaluations.", "PrimaryOutcomeTimeFrame":"From baseline until 1 day following the final radiotherapy fraction, assessed for a maximum of 28 radiotherapy fractions." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"To evaluate the efficacy of APN201 in the prevention of radiation-induced dermatitis", "SecondaryOutcomeDescription":"The following parameters are used for efficacy evaluations:\n\nTime to ≥ grade 2 radiation dermatitis\nIncidence of ≥ grade 2 radiation dermatitis\nSeverity of radiation dermatitis\nPain intensity (pain on touching the skin) due to radiation therapy\nIrradiated skin evaluations using the digital wound documentation system W.H.A.T. (wound healing analysing tool) and a spectrophotometer", "SecondaryOutcomeTimeFrame":"From baseline until 1 day after the final radiotherapy fraction, assessed for a maximum of 28 radiotherapy fractions." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWomen ≥ 18 years of age, with breast cancer, treated by breast conserving surgery and scheduled to receive adjuvant radiotherapy to the breast alone\nBra cup size ≤D\nKarnofsky performance status of ≥ 80%\nWomen of childbearing potential must have a negative pregnancy test before study entry and must agree to use a medically acceptable method of birth control throughout the study period\nAbility to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\nBilateral breast cancer\nInflammatory breast cancer\nLymphangiosis carcinomatosa\nMedically significant dermatologic conditions affecting the irradiated area\nPlanned use of other agents with the aim of preventing and/or treating radiation dermatitis\nConcomitant medications which might exacerbate radiation dermatitis\nHistory of previous radiation therapy of the breast\nPregnancy or breastfeeding\nHaving received any other investigational agent within 4 weeks before enrolment\nUncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Medical University Graz; Department of Therapeutic Radiology and Oncology", "LocationCity":"Graz", "LocationZip":"8036", "LocationCountry":"Austria" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003872", "ConditionMeshTerm":"Dermatitis" },{ "ConditionMeshId":"D000011855", "ConditionMeshTerm":"Radiodermatitis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" },{ "ConditionAncestorId":"D000011832", "ConditionAncestorTerm":"Radiation Injuries" },{ "ConditionAncestorId":"D000014947", "ConditionAncestorTerm":"Wounds and Injuries" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3802", "ConditionBrowseLeafName":"Breast Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5650", "ConditionBrowseLeafName":"Dermatitis", "ConditionBrowseLeafAsFound":"Dermatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13284", "ConditionBrowseLeafName":"Radiodermatitis", "ConditionBrowseLeafAsFound":"Radiation-induced Dermatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13262", "ConditionBrowseLeafName":"Radiation Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" } ] } } } } } }