Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 93
Summary
- Conditions
- Chemotherapy Effect
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention 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 (Investigator)Masking Description: Blind ramdomization and blind final evaluationPrimary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT03373032
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gil Facina, PHD Federal University of Sao Paulo
Get Well Soon