NCT03373032

Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Women will be recruited 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 Clínica de Oncologistas Associados Centro Integrado de Oncologia, located at Rua Gabriel Monteiro da Silva, 454. Patients will consecutively be selected by order of entry in the chemotherapy recorded in the log and randomized in one of three intervention groups. Complying with all the research's ethical aspects, the following procedures will apply: 1st clarify the study's objectives;2nd sign the Term of Free and Informed Consent, signed in two ways, as one stays with the patient; 3rd espond to the evaluation form in the following items: socioeconomic aspects, main complaint, family history, personal history, surgical data, pathological anatomy, radiotherapy, chemotherapy, hormone therapy, sensitivity and perimetry;4 th physical exams. Completed the FACT-TAXANE questionnaire. Patients will be evaluated in the first and tenth sessions.

Conditions

• Chemotherapy Effect

Interventions

Type	Name	Description
OTHER	Stiper	Stiper silicon tablets, for acupunture's stimulation of meridian points, the Stiper's chemical composition is nothing more than SiO 2 - (silicon dioxide) the shape of the quartz stone (silicon rich).They will perform the treatment with the "Stiper" silicon inserts, which will be applied and fixed by plasters at the acupuncture points, duration of 05 minutes.
OTHER	Acupuncture	Treatment with a systemic needle to stimulate meridian acupuncture points, treatment begins with asepsis with 70% alcohol-soaked cotton in the region of the acupoints and then sterile and disposable needles (0.25 mm x 30 mm) will be inserted in both limbs, will be placed in the following regions: shoulders, thorax, legs and feet with the puncture order from bottom to top,duration of 30 minutes.
OTHER	Exercise	Will perform pre-defined kinesiotherapy based on the stretching of cervical musculature and scapular waist, lumbar spine and lower limbs with exercises for WM and upper limb (MS) and lower limb (MI) strength with a duration of 30 minutes.
OTHER	Follow Up	Use of the therapeutic massager, in hands and feet, to stimulate region's sensitivity, women who were submitted to the chemotherapy treatment with Taxane and continued with changes in sensitivity. Once in each dermatome, adding time of 5 minutes of application on average.
OTHER	Observation	The waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C.

Timeline

• Start date: 2017-12-20
• Primary completion: 2022-10-25
• Completion: 2023-04-30
• First posted: 2017-12-14
• Last updated: 2023-05-06

Locations

1 site across 1 country: Brazil