Chemotherapy Effect Clinical Trial
— AcupunctureOfficial title:
Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
Verified date | May 2023 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: to compare different therapies employing acupuncture needles, silicon pellets and kinesiotherapy in breast cancer patients to taxane chemotherapy cycles. Methods:The present study will be carried out at the Oncomastology outpatient clinic of the UNIFESP (Federal University of São Paulo) Gynecology Department's Discipline of Mastology - Escola Paulista de Medicina (EPM) and the Oncology Clinic Associated Center of Oncology, located at Rua Gabriel Monteiro da Silva, 454. randomized clinical trial will be conducted to define the treatment. Patients will be allocated into three groups (Group A: Stiper, Group B: Acupuncture, Group C: Kinesiotherapy and Group D After treatment ) who will receive treatment once a week for eight consecutive weeks. Group - S-observation.124 patients will be randomized in one of the three groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be evaluated in the first and tenth sessions. Keywords: Acupuncture, Breast Neoplasm, Chemotherapy.
Status | Completed |
Enrollment | 79 |
Est. completion date | April 30, 2023 |
Est. primary completion date | October 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - women over 18 years old - women submitted to chemotherapy with taxanes - the 1th cycle both neoadjuvant and adjuvant with staging from I to III no mental changes Exclusion Criteria: - Women with preexisting diseases such as locoregional or distant cancer, previous joint pain, - rheumatic disease, - who are not undergoing chemotherapy with Anthracyclics and / or Cisplatin - acupuncture in another service in the last three will be excluded. |
Country | Name | City | State |
---|---|---|---|
Brazil | Brazil Federal University São Paulo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Beck Anxiety Inventory (BAI) | The score is classified according to 4 ranges that define the patient's degree of anxiety (from 0 to 7: Minimum Anxiety; from 8 to 15: Mild Anxiety; from 16 to 25: Moderate Anxiety; 26 to 63:
Severe Anxiety). |
Baseline, Ten Weeks | |
Primary | Measure sensitivity changes | It will be evaluated with an estiometer for sensitivity changes (green, blue, violet, red, orange, pink) the lighter color green represents a better sensitivity and as this color becomes darker it represents a worsening of sensitivity reaching the pink color.
Visual Scale 0-10 0 no pain and 10 unbearable pain |
One day, Two weeks, Ten weeks | |
Primary | Tongue inspection Changes | Tongue assessments will be recorded by photograph before and after treatment and the following characteristics will be observed: Humidity, Color, Coating, Size, Movement, Other findings. | Baseline, Ten Weeks | |
Secondary | Questionnaires FACT G + TAXANES | To derive a FACT-Taxane Trial Outcome Index (TOI) Score range: 0-120 To Derive a FACT-G total score Score range: 0-108 To Derive a FACT-Taxane total score Score range: 0-172 | Baseline, Ten Weeks | |
Secondary | Sensitivity changes with peridell | Intervention session using a massager Peridell®? therapy, with subsequent reassessment of sensitivity. | One day | |
Secondary | Pain MC Gill | These four groups are organized into 20 subgroups according to the painful sensation. Subgroups 1 to 10 represent sensitive responses to the painful experience (traction, heat, torsion, among others): the descriptors of subgroups 11 to 15 are affective responses (fear, punishment, neurovegetative responses, etc.). Subgroup 16 is evaluative (assessment of the overall experience) and those from 17 to 20 are miscellaneous. | Baseline, Ten Weeks | |
Secondary | Beck Depression Inventory (BDI) | The higher the total score of the Inventory, the worse the depressive state of the patient. This score is classified according to 4 bands that define the degree of patient's depression (from 0 to 13: No Depression; from 14 to 19: Mild Depression; from 20 to 28: Moderate depression; 29 to 63: Severe Depression). | Baseline, Ten Weeks |
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