Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
- Conditions
- Chemotherapy Effect
- Interventions
- Other: StiperOther: ExerciseOther: Follow UpOther: AcupunctureOther: Observation
- Registration Number
- NCT03373032
- Lead Sponsor
- Federal University of São Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 79
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stiper - A Stiper Stiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks Exercise - C Exercise Exercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks Follow Up - D Follow Up Selected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager Acupuncture - B Acupuncture Acupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks Observation - S Observation Group patients who were unable to participate in the intervention group A / B and C. In this group, only the evaluation will be performed.
- Primary Outcome Measures
Name Time Method Measure sensitivity changes 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 painTongue inspection Changes 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.
- Secondary Outcome Measures
Name Time Method Sensitivity changes with peridell One day Intervention session using a massager Peridell®️ therapy, with subsequent reassessment of sensitivity.
Questionnaires FACT G + TAXANES Baseline, Ten Weeks To derive a FACT-Taxane Trial Outcome Index (TOI) Score range: 0-120 To Derive a FACT-G total score Score range: 0-108 To Derive a FACT-Taxane total score Score range: 0-172
Pain MC Gill Baseline, Ten Weeks These four groups are organized into 20 subgroups according to the painful sensation. Subgroups 1 to 10 represent sensitive responses to the painful experience (traction, heat, torsion, among others): the descriptors of subgroups 11 to 15 are affective responses (fear, punishment, neurovegetative responses, etc.). Subgroup 16 is evaluative (assessment of the overall experience) and those from 17 to 20 are miscellaneous.
Beck Depression Inventory (BDI) Baseline, Ten Weeks The higher the total score of the Inventory, the worse the depressive state of the patient. This score is classified according to 4 bands that define the degree of patient's depression (from 0 to 13: No Depression; from 14 to 19: Mild Depression; from 20 to 28: Moderate depression; 29 to 63: Severe Depression).
Trial Locations
- Locations (1)
Brazil Federal University São Paulo
🇧🇷São Paulo, SP, Brazil