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Completed

NCT Number: NCT03373032

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

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.

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Key information

Conditions

Chemotherapy Effect Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Motor Activity

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brazil Federal University São Paulo

São Paulo, 04020-060, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stiper

Other

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.

Acupuncture

Other

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.

Exercise

Other

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.

Follow up

Other

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.

observation

Other

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

Primary outcomes

  1. Measure sensitivity changes

    Time frame: 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

  2. Tongue inspection Changes

    Time frame: 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 outcomes

  1. Questionnaires FACT G + TAXANES

    Time frame: 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

  2. Sensitivity changes with peridell

    Time frame: One day

    Intervention session using a massager Peridell®️ therapy, with subsequent reassessment of sensitivity.

  3. Pain MC Gill

    Time frame: 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.

  4. Beck Depression Inventory (BDI)

    Time frame: 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).

Other outcomes

  1. Beck Anxiety Inventory (BAI)

    Time frame: Baseline, Ten Weeks

    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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Acronym: Acupuncture

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2017
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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