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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||93 participants|
|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 Description:||Blind ramdomization and blind final evaluation|
|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|
Active Comparator: Stiper
Stiper,patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 10 weeks
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
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
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.
- 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
- Changes in FACT G + TAXANES [ Time Frame: Baseline, 10 Weeks ]Changes in Mc Gill Pain Questionnaire
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
|Contact: Roberta Costa Luz, MDemail@example.com|
|Contact: Roberta Costa Luz, MDfirstname.lastname@example.org|
|Federal University of São Paulo||Recruiting|
|São Paulo, Sao Paulo, Brazil|
|Contact: Roberta Costa Luz, MD 5511993037871 email@example.com|
|Principal Investigator:||Gil Facina, PHD||Federal University of Sao Paulo|