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

NCT03373032 | Completed DMC

• 1 other identifier: FUSaoPaulo,PT 6
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy Effect

Keywords

Physical Activity; Sensory Neuropathy; Acupuncture; Depression; Anxiety; Skin Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Questionnaires FACT G + TAXANES

  Baseline, Ten Weeks

• Sensitivity changes with peridell

  One day

• Pain MC Gill

  Baseline, Ten Weeks

• Beck Depression Inventory (BDI)

  Baseline, Ten Weeks

Other Outcomes (1)

• Beck Anxiety Inventory (BAI)

  Baseline, Ten Weeks

Study Arms (5)

Stiper - A

EXPERIMENTAL

Stiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks

Other: Stiper

Acupuncture - B

EXPERIMENTAL

Acupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks

Other: Acupuncture

Exercise - C

EXPERIMENTAL

Exercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks

Other: Exercise

Follow Up - D

EXPERIMENTAL

Selected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager

Other: Follow Up

Observation - S

OTHER

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

Interventions

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.

Stiper - A

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.

Acupuncture - B

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.

Exercise - C

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.

Follow Up - D

Observation OTHER

The waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C.

Also known as: Control

Observation - S

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: female breast cancer patients under taxanes based chemotherapy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Brazil Federal University São Paulo

São Paulo, São Paulo, 04020-060, Brazil

Location

MeSH Terms

Conditions

Motor Activity; Depression; Anxiety Disorders

Interventions

Acupuncture Therapy; Exercise; Observation

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Methods; Investigative Techniques

Study Officials

• Gil Facina, PHD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blind ramdomization and blind final evaluation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: 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. 124 envelopes were available where 31 would contain code that allocates the patients in group A, 31 in group B, 31 in group C or 31 group Follow Up .No Intervention Group - S 'Class wait '. This was done in order to avoid influences such as the therapist's or patient's preferences related to the intervention.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: December 14, 2017
• Study Start: December 20, 2017
• Primary Completion: October 25, 2022
• Study Completion: April 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)