Clinical study to evaluate the effectiveness of hyaluronic acid 0.2% cream for the prevention of skin toxicity in breast cancer patients treated with post-operative radiotherapy
- Conditions
- RadiodermatitisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN89600912
- Lead Sponsor
- IBSA, Institut Biochimique S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 86
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method