Breast Cancer Clinical Trial
— CLODISOfficial title:
Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective
This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing. - Patient with a second seroma puncture with a volume greater than or equal to 250 ml. - Neo adjuvant chemotherapy authorized. - Absence of known metastases. - Patient has given written consent. Exclusion Criteria: - Mastectomy with immediate reconstruction. - Partial mastectomy. - Concurrent bilateral mastectomy. - Delay in healing observed at inclusion. - Patient under legal protection. - Chronic respiratory failure. - Patient with a pacemaker. - Personality disorders and known progressive psychiatric pathology. - Inability to submit to trial follow-up |
Country | Name | City | State |
---|---|---|---|
France | Centre Françis Baclesse | Caen | |
France | TANQUEREL Julie | Caen |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of puncture(s) after inclusion in both patient groups | In each group, we will count the number of punctures performed after the 2nd puncture with a volume > 250ml (inclusion). | 180 days | |
Secondary | The time required to take charge of adjuvant treatments | Deferral of adjuvant therapy related to seroma: Treatment regimen and adjuvant appointments will be collected at inclusion. Each deviation will be analyzed and attributed or not to the presence or complications of seroma. | 180 days | |
Secondary | Volume punctured after inclusion in both patient groups. | For each new puncture, the volume of serolymphatic fluid will be measured and the time between two punctures analyzed | 180 days | |
Secondary | comparison of the average change Quality of life scores between each arm | Quality of life is assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer (study inclusion and exit). The EORTC QLQ-C30 questionnaire, resulting in a score for the quality of life between 0 to 100. | 180 days | |
Secondary | comparison of the average change anxiety scores between each arm | Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale (study inclusion and exit) | 180 days | |
Secondary | comparison of the average change Pain scores between each arm | Numerical rating scale for pain (EN) The EN evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation", 3 "pain threshold", 10 "pain as bad as could be.(at each visit), Neuropathic Pain (DN4) (inclusion and study exit) |
180 days | |
Secondary | The aesthetic impact on the puncture site. | The evaluation of the aesthetic impact on the puncture zone will be carried out by comparing the photographs taken at the inclusion, during the visit to the consultation at 10-15 days after the last puncture (for the standard arm) and at 10-15 days after the removal of the bandage device and finally during the consultation with the oncologist. | 180 days | |
Secondary | Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture | Based on the observation grids carried out by the 2 professionals during a separate evaluation, we compare the 4 items defined to the indication chosen for the puncture as well as the volume of puncture when it is carried out. | 180 days |
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