Radiodermatitis Skin and Connective Tissue Diseases Radiodermatitis
Conditions
Interventions
The tested Investigational Product HA 0.2% cream, or Ialuset® cream, is a CE-marked medical device, classified as Class IIb, available as 100 g tubes. The neutral comparator (placebo) cream is physic
Sponsors
IBSA, Institut Biochimique S.A
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females aged =18 years 2. Having undergone curative surgery for unilateral stage I-III breast cancer and scheduled for adjuvant LRT with conventional fractionation or hypofractionation according to the site guidelines; performance status ECOG 0-1 having given written informed consent to participate in the study according to Good Clinical Practice (GCP) 3. Able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement 4. Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period; for all females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) the pregnancy test result must be negative at Screening/Enrolment visit of the study
Exclusion criteria
Exclusion criteria: 1. Presence of any dermatologic disease or condition or conditions known to alter skin appearance or physiologic response that might interfere with evaluation of the test site reaction or contraindicate participation 2. Ipsilateral relapsing/second breast tumour or previous LRT on the same volumes 3. Concomitant chemotherapy 4. Patients treated with mastectomy and autologous reconstruction 5. Positioning of “bolus” on chest wall 6. Allergy to the components contained in the IP; history of anaphylaxis or allergic reactions to any other allergens potentially affecting the study outcome 7. Underlying disease (T-lymphocytes impairment) or concomitant treatment with systemic (oral, parenteral) corticosteroids, as well as with any other drugs known to or suspected of compromising the subject's immune system (immunosuppressive therapy) 8. Clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters 9. Major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study 10. Positive or missing pregnancy test at Screening/Enrolment visit, or breastfeeding women 11. Concomitant participation in other clinical trials or participation in the evaluation of any IMDs/IMPs during 3 months before this study or previous participation in the same study 12. Participation in the study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of patients developing skin reactions (radiodermatitis) of Grade = 2, as assessed by the Investigator according to the RTOG score, at the end of the LRT period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion (%) of patients developing skin reactions (radiodermatitis) of Grade = 2, as assessed by the Investigator according to the RTOG score, during the LRT period and in the 2-week follow-up 2. Skin reaction (erythema/inflammation) severity, as assessed by skin reflectance spectrophotometry (SRS) at the Screening/Enrolment visit (baseline assessment), after irradiation on Day 1 (LRT start), and on each of the subsequent weekly Control Visits during LRT, as well as at the end of the 2-week follow-up period (End-of-Study visit) 3. Time (days) to reach a Grade = 2 skin reaction (radiodermatitis), as assessed by the Investigator according to the RTOG score at each post-baseline control visit 4. Total delivered dose (Gy) to reach a Grade = 2 skin reaction (radiodermatitis), as assessed by the Investigator according to the RTOG score at each post-baseline control visit 5. Proportion (%) of patients developing a Grade = 3 skin toxicity at the irradiated site, as assessed by the Investigator according to the RTOG score, at each control visit 6. Patient's self-perceived Level of Discomfort at the irradiated site as assessed on a 0-100 mm Visual Analog Scale (VAS), anchored to 0 = no discomfort at all and 100 = worst possible discomfort, at each control visit 7. Patient’s Quality of Life (QoL), as assessed by the patient using a self-administered QoL questionnaire (Short Form 36 – SF36) at screening/enrolment visit, start of LRT visit and at the follow-up visit 8. The Overall Treatment Performance, judged by the Investigator using a 5-point scale (4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = None) at the end of the study 9. The safety of use of study medication evaluated by means of AEs and Treatment Emergent AEs (TEAEs) (Common Terminology Criteria for Adverse Events v4.03) (incidence, severity, duration, and causal relationship with the IP will be assessed), occurring at any time during the study 10. Overall Treatment Tolerability, independently judged by the In | — |
Countries
Switzerland
Outcome results
None listed