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

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ClinicalTrials.gov Identifier: NCT03373032
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gil Facina, Federal University of São Paulo

Brief Summary:

Objective.To compare different therapies that employ acupuncture needles, silicon pellets and kinesiotherapy in patients with breast cancer submitted to taxane chemotherapy cycles. Methods. study will be carried out at the Oncomastology outpatient clinic of the Discipline of Mastology of the Department of Gynecology of the Federal University of São Paulo (UNIFESP) - 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 or Group C: Kinesiotherapy) who will receive treatment once a week for eight consecutive weeks. 93 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. will be evaluated in the first and tenth sessions.

Keywords: Acupuncture, Breast Neoplasm, Chemotherapy.


Condition or disease Intervention/treatment Phase
Chemotherapy Effect Other: Stiper Other: acupuncture Other: Control Not Applicable

Detailed Description:
Will recruited be women at the Oncomastology outpatient clinic of the Discipline of Mastology of the Department of Gynecology of the Federal University of São Paulo (UNIFESP) - Escola Paulista de Medicina (EPM) and Clínica de Oncologistas Associados Centro Integrado de Oncologia, located at Rua Gabriel Monteiro da Silva, 454. will be consecutively selected by order of entry in the chemotherapy recorded in the book ata and randomized in one of three intervention groups. Accomplishing all the ethical aspects of the research the following procedures: 1º will be clarified as to the objectives of the study; 2º sign the Term of Free and Informed Consent, signed in two ways, because one stays with the patient; 3º will respond 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; 4º will do physical exams. Completed the FACT-TAXANE questionnaire. evaluated in the first and tenth sessions

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A computer program will produce a randomization list, which will generate random sequences for the three groups and will be recorded and placed in sealed, opaque, non-translucent and sequentially numbered envelopes. This intervention should be done by someone else and not by the principal investigator. These envelopes will be opened after the consent of the patient to participate in the research and only then will the researcher know as well as the patient the group that she will be allocated. 93 envelopes were available where 31 would contain code that allocates the patients in group A, 31 in group B and 31 in group C. This choice was chosen to avoid influences of the preference of the therapist or patient in relation to the intervention
Masking: Single (Investigator)
Masking Description: Blind ramdomization and blind final evaluation
Primary Purpose: Prevention
Official Title: Acupuncture and Kinesiotherapy on Skin Sensitivity of Patients With Breast Cancer Subject to Chemotherapy With Taxans: Ramdomized Clinical Trials
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : July 10, 2021
Estimated Study Completion Date : January 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Stiper
Stiper,patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 10 weeks
Other: Stiper
Stiper silicon tablets, for stimulation of meridian points of acupuncture, the chemical composition of the Stiper 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.

Active Comparator: Acupuncture
Acupuncture with needles, patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 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.

Placebo Comparator: Control
Control Exercise,patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 10 weeks
Other: Control
Will perform pre-defined kinesiotherapy based on stretching of the 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.




Primary Outcome Measures :
  1. Measure sensitivity changes [ Time Frame: One day, Two months, Ten weeks ]

    It will be evaluated with an ossiometer 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 to pink color.

    Visual Scale 0-10 0 without pain and 10 unbearable pain



Secondary Outcome Measures :
  1. Changes in FACT G + TAXANES [ Time Frame: Baseline, 10 Weeks ]
    Changes in Mc Gill Pain Questionnaire



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients with breast cancerin cycles of taxans chemotherapy
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373032


Contacts
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Contact: Roberta Costa Luz, MD 551139926082 roberta_pitta@hotmail.com
Contact: Roberta Costa Luz, MD 5511993037871 roberta_pitta@hotmail.com

Locations
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Brazil
Federal University of São Paulo Recruiting
São Paulo, Sao Paulo, Brazil
Contact: Roberta Costa Luz, MD    5511993037871    roberta_pitta@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Gil Facina, PHD Federal University of Sao Paulo

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Responsible Party: Gil Facina, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03373032     History of Changes
Other Study ID Numbers: FUSaoPaulo,PT 6
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gil Facina, Federal University of São Paulo:
Physical Activity
Sensory Neuropathy
Acupuncture
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases