Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Measure sensitivity changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Blind ramdomization and blind final evaluation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Stiper - A
Stiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks
干预措施: Stiper (Other)
Acupuncture - B
Acupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks
干预措施: Acupuncture (Other)
Exercise - C
Exercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks
干预措施: Exercise (Other)
Follow Up - D
Selected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager
干预措施: Follow Up (Other)
Observation - S
Group patients who were unable to participate in the intervention group A / B and C. In this group, only the evaluation will be performed.
干预措施: Observation (Other)
结局指标
主要结局
Measure sensitivity changes
时间窗: One day, Two weeks, Ten weeks
It will be evaluated with an estiometer for sensitivity changes (green, blue, violet, red, orange, pink) the lighter color green represents a better sensitivity and as this color becomes darker it represents a worsening of sensitivity reaching the pink color. Visual Scale 0-10 0 no pain and 10 unbearable pain
Tongue inspection Changes
时间窗: Baseline, Ten Weeks
Tongue assessments will be recorded by photograph before and after treatment and the following characteristics will be observed: Humidity, Color, Coating, Size, Movement, Other findings.
次要结局
- Sensitivity changes with peridell(One day)
- Questionnaires FACT G + TAXANES(Baseline, Ten Weeks)
- Pain MC Gill(Baseline, Ten Weeks)
- Beck Depression Inventory (BDI)(Baseline, Ten Weeks)
研究者
Gil Facina
Professor Doctor
Federal University of São Paulo