Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
Condition: Chemotherapy Effect
MeSH terms: Hypersensitivity
Study type: Interventional

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.
    

Intervention name(s): Stiper; Acupuncture; Exercise; Follow Up; Observation
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 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.; 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.; 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.; 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.; The waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C.
Other intervention name(s): Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A computer program will produce a randomization list, which will generate random sequences for the three groups and will be recorded and placed in sealed, opaque, non-translucent and sequentially numbered envelopes. This intervention should be done by someone else and not by the principal investigator. These envelopes will be opened after the consent of the patient to participate in the research and only then will the researcher know as well as the patient the group that she will be allocated. 124 envelopes were available where 31 would contain code that allocates the patients in group A, 31 in group B, 31 in group C or 31 group Follow Up .No Intervention Group - S 'Class wait '. This was done in order to avoid influences such as the therapist's or patient's preferences related to the intervention.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Physical Activity; Sensory Neuropathy; Acupuncture; Depression; Anxiety; Skin Sensitivity