Breast Cancer Female Clinical Trial
Official title:
Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | June 2026 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: Patients must meet ALL of the following criteria to be included in the study: 1. Patients over 18 years of age 2. Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy. 3. That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index<ó=15). 4. That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points). 5. Who have not received any treatment for vulvo-vaginal atrophy in at least the previous 6 months. Purely moisturizing or emollient treatments that do not contain any regenerating substance (hyaluronic acid, gotu kola, vitamin E or rosehip oil) are not considered exclusive. 6. That they agree to participate and give their written I consent. Exclusion Criteria: Patients who present ANY of the following criteria may not be selected to participate in this study: 1. Medical or surgical history that at the discretion of the researcher does not allow participation in the study. 2. Refusal to participate in the study and to sign consent. 3. Be on chemotherapy treatment at the time of inclusion in the study. 4. Have completely completed the adjuvant hormonal treatment. 5. Have a history of vulvar, vaginal and/or cervical malignancy. 6. Have received radiation therapy to the pelvic and/or genital region. 7. Sjögren's syndrome and other pathologies that occur with mucosal involvement. 8. Present any type of disease that occurs with alteration of collagenogenesis. 9. Intake of other cytotoxic drugs that lead to mucositis and alterations of tissue regeneration in the last 6 months. 10. Have previously received laser and/or radiofrequency treatment for the treatment of genital atrophy or other pelvic floor dysfunctions. 11. Active urinary and/or genital tract infection. 12. Diagnosis of gestation at the time of recruitment. 13. History of malignant neoplasm of the urinary tract. 14. Have severe stress urinary incontinence (Sandvik test with a score equal to or greater than 8) 15. Diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification. 16. Any other condition which, in the opinion of the investigator, means that the patient is not in a position to understand the implication of participating in the study and/or of following the established procedures. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Lumenis Be Ltd., Mucosa Innovations, S.L. |
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* Note: There are 67 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of symptoms at the vulvovaginal level and their intensity | This group will include the following items:
Pain with sexual intercourse (dyspareunia). Feeling of vaginal stiffness. Dryness. Vulvar itching. Vulvar and/or vaginal burning. Urinary frequency (more than 8 times a day). Burning when urinating (dysuria). The way to measure the intensity of these symptoms will be through Visual Analog Scale Of Symptom Intensity, with absolute values ranging from 0 to 10. We will consider improvement a reduction of 2 or more points in at least 50% of the items. Meeting only this item is already considered an efficacy criterion. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Impact in the quality of life of vulvo-vaginal symptoms. | The tool used will be the Sexual Function-Vaginal Changes Questionnaire. Scores equal to or less than 24 points will result in an impact on quality of life. A rise of 3 or more points is considered a significant improvement.
The severity levels of quality of life impairment will be as follows: Mild (scores between 24 and 17) Moderate (scores between 16 and 8) Severe (scores between 7 and 1) |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Changes in vulvar physical examination | We will use the following measurement system:
Vulvar Health Index Score. It is based on the macroscopic inspection of the vulva performed through a colposcope. The scores range from 0 to 24, being higher to greater atrophy. It is considered a diagnosis of atrophy scores greater than 8 or having obtained 3 points in any of the items. The degrees of gravity are set as follows: Between 9 and 14 points, mild Between 15 and 20 points, moderate Between 21 and 24 points, severe. A reduction of 3 or more points in the overall score or at least one point will be considered a favorable response if there has been an item with a score of 3. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Changes in vaginal physical examination | We will use the following measurement systems:
Vaginal Health Index Score. It is based on the macroscopic inspection of the vagina performed through a colposcope. Scores range from 5 to 25 points (scores equal to or less than 15 are considered diagnostic of atrophy). It is carried out by assessing different items related to exploratory findings. We can categorize the scores into different degrees of severity of vulvo-vaginal atrophy objectified to the examination: >from 15 points, absence of atrophy Between 15 and 13 points, mild Between 12 and 9 points, moderate Between 8 and 5 points, severe An increase of 2 or more points in the overall score will be considered a favourable response. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Thickness of the vaginal epithelium | The collection of the sample will consist of taking biopsy of vaginal mucosa using a 4 mm punch as an instrument.
Once obtained, the sample will be stained with hematoxylin-eosin and subjected to microscopic assessment. The unit of measurement shall be in nanometers. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Quantification of cellular glycogen | The collection of the samples will consist of taking biopsies of vaginal mucosa using a 4 mm punch as an instrument.
The sample will undergo the Schiff technique (PAS) and the number of stained cells will be determined. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Number of capillaries in vaginal mucosa | The collection of samples will consist of taking biopsies of vaginal mucosa using a 4 mm punch as an instrument.
The immunohistochemical technique will be applied with antibodies against CD31 and a quantitative assessment of the number of capillaries / field of 40 increases will be carried out. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Amount of Lactobacillus in vaginal microbiota | It will be measured through microbiological study. Samples shall be obtained by vaginal exudate.
The measurements will be made by WERFEN system and PCR technique. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Amount of Candida spp in vaginal microbiota | It will be measured through microbiological study. Samples shall be obtained by vaginal exudate.
The measurements will be made by WERFEN system and PCR technique. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Amount of Gardnerella vaginalis in vaginal microbiota | It will be measured through microbiological study. Samples shall be obtained by vaginal exudate.
The measurements will be made by WERFEN system and PCR technique. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Free glycogen detection in vaginal discharge | It will be measured through microbiological study. Samples shall be obtained by vaginal exudate.
Free glycogen detection will be performed using a commercial kit. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Vaginal pH | It will be measured through microbiological study. Samples shall be obtained by vaginal exudate. | From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Skin elasticity | It will be performed with the Dual cutometer MPA 580 ® and will determine different characteristics of the vulvar skin.
The value will be given in the unit of measurement N / m². |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Amount of transdermal water in the skin | It will be performed with the Dual cutometer MPA 580 ® and will determine different characteristics of the vulvar skin.
The value will be given in the unit of measurement g/h/m². |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Skin pigmentation | It will be performed with the Dual cutometer MPA 580 ® and will determine different characteristics of the vulvar skin.
The degree of pigmentation of the skin will be determined based on the concentration of melanin. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Primary | Degree of vascularization of the skin | It will be performed with the Dual cutometer MPA 580 ® and will determine different characteristics of the vulvar skin.
To determine the degree of vascularization of the skin, specific wavelengths will be used, corresponding to the maximum level of spectral absorption of hemoglobin and avoiding other color influences (for example, bilirubin). The result corresponding will be immediately displayed in the form of index figures, on a scale of 0 - 999. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Secondary | Presence of bladder hyperactivity clinic | The following questionnaires will be used:
Bladder control self-assessment questionnaire. This scale measures 2 items: Presence of symptoms and discomfort generated by them. The range of values for each of them goes from 0 to 12, with the severity levels being the following in both cases: 0-->Absence of symptoms/discomfort. 1-3-->Mild symptoms/discomfort. 4-6-->Moderate symptoms/discomfort. 7-9-->Severe symptoms/discomfort. 10-12-->Very serious symptoms/discomfort. |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Secondary | Presence of urge urinary incontinence | The Sandvik Test will be used. It consists of 2 sections whose scores are multiplied. The range of scores goes from 0 to 12, with the only possible values being 0, 1, 2, 3, 4, 6, 8, 9 and 12. The degree of urinary incontinence shall be classified as follows:
0-->Absence of incontinence 1-2-->Mild urinary incontinence 3-6-->Moderate urinary incontinence 8-9-->Severe urinary incontinence 12-->Very severe urinary incontinence |
From prior consultation at the beginning of treatment to 24 months after it ends. | |
Secondary | Impact of urinary incontinence on quality of life | We will use the International Consultation on Incontinence Questionnaire-Short Form.
Of this scale we will only use in section that measures the degree of discomfort caused by incontinence and that reaches the values of 1 to 10. |
From prior consultation at the beginning of treatment to 24 months after it ends. |
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