Clinical trial NCT03373032: Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
Official title: Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy Effect
Keywords: Physical Activity
Sensory Neuropathy
Acupuncture
Depression
Anxiety
Skin Sensitivity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure sensitivity changes
timeFrame: One day, Two weeks, Ten weeks
measure: Tongue inspection Changes
timeFrame: Baseline, Ten Weeks
Secondary outcomes:
measure: Questionnaires FACT G + TAXANES
timeFrame: Baseline, Ten Weeks
measure: Sensitivity changes with peridell
timeFrame: One day
measure: Pain MC Gill
timeFrame: Baseline, Ten Weeks
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, Ten Weeks
Other outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline, Ten Weeks
Locations:
city: São Paulo
country: Brazil
facility: Brazil Federal University São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Gil Facina, PHD
role: PRINCIPAL_INVESTIGATOR
References: