Chemotherapy EffectAcupunctureNCT03373032
Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
A study testing Stiper, Acupuncture and Exercise in people with Chemotherapy Effect, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Stiper, Acupuncture and Exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2017to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Brazil Federal University São Paulo
São Paulo, São Paulo, 04020-060
About this study
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.
Read the detailed description
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.
- Conditions
- Chemotherapy Effect
- Being tested
- Stiper, Acupuncture, Exercise, Follow Up, Observation
- Keywords
- Physical Activity, Sensory Neuropathy, Acupuncture, Depression, Anxiety, Skin Sensitivity
- Medical subject headings
- Motor Activity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StiperOther
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.
AcupunctureOther
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.
ExerciseOther
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 UpOther
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.
ObservationOther
Also called Control
The waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C.
| Study group | Role | What they receive |
|---|---|---|
| Stiper - A | Experimental | Stiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks Receives: Other: Stiper |
| Acupuncture - B | Experimental | Acupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks Receives: Other: Acupuncture |
| Exercise - C | Experimental | Exercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks Receives: Other: Exercise |
| Follow Up - D | Experimental | Selected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager Receives: 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, Ten Weeks
Secondary outcomes (4)
Questionnaires FACT G + TAXANES
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
Measured: Baseline, Ten Weeks
Sensitivity changes with peridell
Intervention session using a massager Peridell®️ therapy, with subsequent reassessment of sensitivity.
Measured: One day
Pain MC Gill
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.
Measured: Baseline, Ten Weeks
Beck Depression Inventory (BDI)
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).
Measured: Baseline, Ten Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start20 Dec 2017
- Primary completion25 Oct 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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. 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Facina, Federal University of São Paulo
- Investigators
- Gil Facina, PHD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373032
- Sponsor's protocol ID
- FUSaoPaulo,PT 6
- Acronym
- Acupuncture
- Status last verified
- May 2023
- First submitted
- 9 Nov 2017
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans
- ClinicalTrials.gov ID
- NCT03373032
- Acronym / sponsor ID
- Acupuncture / FUSaoPaulo,PT 6
- Conditions
- Chemotherapy Effect
- Keywords
- Physical Activity, Sensory Neuropathy, Acupuncture, Depression, Anxiety, Skin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- 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. 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.
| Arm | Type | Receives |
|---|---|---|
| Stiper - A | Experimental | Other: StiperStiper, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks |
| Acupuncture - B | Experimental | Other: AcupunctureAcupuncture with needles, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks |
| Exercise - C | Experimental | Other: ExerciseExercise, breast cancer patients during chemotherapy cycles, once a week, during 10 weeks |
| Follow Up - D | Experimental | Other: Follow UpSelected patients from the 3 groups Stiper / Acupuncture / Exercise. One session with a Peridell Massager |
| Observation - S | Other | Other: ObservationGroup patients who were unable to participate in the intervention group A / B and C. In this group, only the evaluation will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StiperStiper 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. | Other | Stiper - A |
| AcupunctureTreatment 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. | Other | Acupuncture - B |
| ExerciseWill 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. | Other | Exercise - C |
| Follow UpUse 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. | Other | Follow Up - D |
| ObservationAlso: ControlThe waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C. | Other | Observation - S |
Primary outcome
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
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.
4 secondary outcomes
Questionnaires FACT G + TAXANES
Time frame: Baseline, Ten Weeks
Sensitivity changes with peridell
Time frame: One day
Pain MC Gill
Time frame: Baseline, Ten Weeks
Beck Depression Inventory (BDI)
Time frame: Baseline, Ten Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Facina, PHD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stiper, Acupuncture and Exercise in people with Chemotherapy Effect, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure sensitivity changes (time frame: One day, Two weeks, Ten weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.