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

Federal University of São Paulo

Status: Completed

Conditions: Chemotherapy Effect

Treatments: Other: Exercise; Other: Stiper; Other: Observation; Other: Follow Up; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03373032

FUSaoPaulo,PT 6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 5 patient groups

Stiper - A

Experimental group

Description:

Stiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks

Treatment:

Other: Stiper

Acupuncture - B

Experimental group

Description:

Acupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks

Treatment:

Other: Acupuncture

Exercise - C

Experimental group

Description:

Exercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks

Treatment:

Other: Exercise

Follow Up - D

Experimental group

Description:

Selected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager

Treatment:

Other: Follow Up

Observation - S

Other group

Description:

Group patients who were unable to participate in the intervention group A / B and C. In this group, only the evaluation will be performed.

Treatment:

Other: Observation