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

Acupuncture and Kinesiotherapy on Skin Sensitivity of Patients With Breast Cancer Subject to Chemotherapy With Taxans: Ramdomized Clinical Trials

Sponsors

Lead Sponsor: Federal University of São Paulo

Source 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.

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

Overall Status Recruiting
Start Date December 20, 2017
Completion Date January 20, 2023
Primary Completion Date July 10, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Measure sensitivity changes One day, Two months, Ten weeks
Secondary Outcome
Measure Time Frame
Changes in FACT G + TAXANES Baseline, 10 Weeks
Changes in Beck Depression Inventory (BDI) Baseline, 10 Weeks
Changes in Peridell (Finished group) One day
Enrollment 118
Condition
Intervention

Intervention Type: Other

Intervention Name: Stiper

Description: 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, duration of 05 minutes

Arm Group Label: Stiper

Intervention Type: Other

Intervention Name: acupuncture

Description: 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.

Arm Group Label: Acupuncture

Intervention Type: Other

Intervention Name: Control

Description: 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.

Arm Group Label: Control

Intervention Type: Other

Intervention Name: Finished

Description: Use of the therapeutic massager, in hands and feet, to stimulate sensitivity in the region, women who were submitted to treatment with chemotherapy with Taxane and continued with changes in sensitivity. Once in each dermatome, adding a time of, on average, 05 minutes of application.

Arm Group Label: Finished

Eligibility

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.

Gender: Female

Gender Based: Yes

Gender Description: female patients with breast cancerin cycles of taxans chemotherapy

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Gil Facina, PHD Principal Investigator Federal University of Sao Paulo
Overall Contact

Last Name: Roberta Costa Luz, MD

Phone: 551139926082

Email: [email protected]

Location
Facility: Status: Contact: Federal University of São Paulo Roberta Pitta Costa Luz, MD 5511993037871 [email protected]
Location Countries

Brazil

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Federal University of São Paulo

Investigator Full Name: Gil Facina

Investigator Title: PHD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Stiper

Type: Active Comparator

Description: Stiper,patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 10 weeks

Label: Acupuncture

Type: Active Comparator

Description: Acupuncture with needles, patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 10 weeks

Label: Control

Type: Placebo Comparator

Description: Control Exercise,patients with breast cancer diagnosis during chemotherapy cycles, 1 a week, 10 weeks

Label: Finished

Type: Other

Description: All finished, of the 3 groups Stiper / Acupuncture / Control. 1session with a Peridell Massager ( hotflowers)

Acronym acupuncture
Patient Data No
Study Design Info

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

Primary Purpose: Prevention

Masking: Single (Investigator)

Masking Description: Blind ramdomization and blind final evaluation

Source: ClinicalTrials.gov