Evaluation of Quality of Life After Facial Hyaluroic Acid Injections Following Treatment for Breast Cancer.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorInstitut Bergonié
About this trial
Breast cancer, the most common cancer in women, is increasingly managed as a chronic disease thanks to therapeutic advances. However, treatments such as chemotherapy and hormonotherapy often induce premature menopause in younger women, leading to skin aging, atrophy, and distressing symptoms that negatively affect quality of life. These cutaneous effects are frequently overlooked despite their psychological and social impact. Hyaluronic acid injections, already well established in aesthetic and reconstructive medicine, may offer a safe, minimally invasive option to restore skin quality, improve self-esteem, and enhance overall well-being in breast cancer survivors. This study aims to assess their efficacy and safety in this specific population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women ≥ 18 years old and ≤ 50 years old.
Non-menopausal status at time of diagnosis of breast cancer (self-reporting).
treated at the Institut Bergonié by chemotherapy (+/- targeted/immunotherapy) and surgical treatment (conservative or not) and/or hormone therapy and/or radiotherapy
who completed their treatment at least 6 months ago including end of treatment with Herceptin but with the exception for ongoing hormone therapy
Disqualifiers
Patients with a history of or declared autoimmune disease or immune system deficiency or undergoing immunosuppressive treatment. A 6-month washout is required.
Patients undergoing or planning to undergo peeling treatment or laser/ultrasound-based or botox treatment or hyaluronic acid injections during the study or having had one of these treatments in the 6 months preceding the study.
Patients showing cutaneous disorders, inflammation or infection (acne, herpes labialis, scars…) at the treatment site or near to this site.
Patients having a known hypersensibility to lidocaine and/or amide local anaesthetic agents or hyaluronic acid and/or proteins from gram-positive bacteria, or with a history of severe allergy or anaphylactic shock.
Trial design
Design model
Single group
Treatments tested in this trial
Inject of hyaluronic acid in the face
DeviceThe patient may receive up to 1 ml (volume of one syringe) of each of the three HA references (between 1 ml and 3 ml maximum). The HA reference(s) to be injected will be chosen on the basis of the investigator's assessment and the patient's desired correction.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Hyaluronic acid injectionOther 1 intervention
Trial outcomes
Primary outcomes
1
Facial appearance following facial hyaluronic acid injection following breast cancer treatment.
Facial appearance will be measured using the score obtained at the "facial appearance" subdomain of the FACE-Q Aesthetics Questionnaire. The score ranges from 0 (worst outcome) to 100 (best outcome).
Time frame
3 months2
Health-related quality of life followig facial hyaluronic acid injection following breast cancer treatment.
Health-related quality of life will be measured using the score obtained at the "health-related quality of life" subdomain of the FACE-Q Aesthetics Questionnaire. The score ranges from 0 (worst outcome) to 100 (best outcome).
Time frame
3 months3
Adverse effects following facial hyaluronic acid injection following breast cancer treatment.
Adverse effects will be measured using the score obtained at the "Adverse effects" subdomain of the FACE-Q Aesthetics Questionnaire. The score ranges from 0 (worst outcome) to 100 (best outcome).
Time frame
3 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Bergonié
Lead sponsor
Ruban Rose
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: