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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Effect
• Intervention / Treatment: Other: Stiper; Other: Acupuncture; Other: Exercise; Other: Follow Up; Other: Observation

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04020-060
      • Brazil Federal University São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stiper - A; Stiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks	Other: Stiper; Stiper silicon tablets, for acupunture's stimulation of meridian points, the Stiper's chemical composition is nothing more than SiO 2 - (silicon dioxide) the shape of the quartz stone (silicon rich).They will perform the treatment with the "Stiper" silicon inserts, which will be applied and fixed by plasters at the acupuncture points, duration of 05 minutes.
Experimental: Acupuncture - B; Acupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks	Other: Acupuncture; Treatment with a systemic needle to stimulate meridian acupuncture points, treatment begins with asepsis with 70% alcohol-soaked cotton in the region of the acupoints and then sterile and disposable needles (0.25 mm x 30 mm) will be inserted in both limbs, will be placed in the following regions: shoulders, thorax, legs and feet with the puncture order from bottom to top,duration of 30 minutes.
Experimental: Exercise - C; Exercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks	Other: Exercise; Will perform pre-defined kinesiotherapy based on the stretching of cervical musculature and scapular waist, lumbar spine and lower limbs with exercises for WM and upper limb (MS) and lower limb (MI) strength with a duration of 30 minutes.
Experimental: Follow Up - D; Selected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager	Other: Follow Up; Use of the therapeutic massager, in hands and feet, to stimulate region's sensitivity, women who were submitted to the chemotherapy treatment with Taxane and continued with changes in sensitivity. Once in each dermatome, adding time of 5 minutes of application on average.
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.	Other: Observation; The waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure sensitivity changes	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	One day, Two weeks, Ten weeks
Tongue inspection Changes	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.	Baseline, Ten Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaires FACT G + TAXANES	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	Baseline, Ten Weeks
Sensitivity changes with peridell	Intervention session using a massager Peridell®️ therapy, with subsequent reassessment of sensitivity.	One day
Pain MC Gill	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.	Baseline, Ten Weeks
Beck Depression Inventory (BDI)	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).	Baseline, Ten Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Anxiety Inventory (BAI)	The score is classified according to 4 ranges that define the patient's degree of anxiety (from 0 to 7: Minimum Anxiety; from 8 to 15: Mild Anxiety; from 16 to 25: Moderate Anxiety; 26 to 63: Severe Anxiety).	Baseline, Ten Weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Physical Activity; Anxiety; Acupuncture; Sensory Neuropathy; Skin Sensitivity
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: FUSaoPaulo,PT 6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No