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Breast NeoplasmsPhase 1/2KITMYCANNCT02406794

Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors

A Phase 1/2 study testing Neuromuscular taping in people with Breast Neoplasms, run by University of Malaga at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Neuromuscular taping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteSpain
Study dates
May 2016to Mar 2017
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be of legal age
  • Having suffered from primary breast cancer with histological confirmation (I-IIIA)
  • Completion of primary carcinoma treatment (surgery, chemotherapy, radiotherapy)
  • To be receiving hormone therapy as an adjunct to the process by aromatase inhibitors (exemestane, anastrozole, letrozole)
  • To present a functional status according to WHO from 0 (asymptomatic, complete and ambulatory activity) or 1 (symptomatic but completely ambulatory, strenuous physical activity restricted but able to perform sedentary gentle activities)
  • To understand correctly Spanish
  • To show their approval by signing the informed consent
  • Having had musculoskeletal disorders attributable to IA.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Regional University Hospital Virgen de la Victoria

    Málaga, Malaga

Other trials in Spain

About this study

Official title: Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women: Randomised Controlled Trial

Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence.

Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.

Being tested
Neuromuscular taping
Keywords
Breast cancer, Hormonal therapy, Aromatase inhibitors, Estrogen deprivation, Myalgia, Arthralgia, Carpal tunnel syndrome, Pressure pain threshold, Neuromuscular taping, Kinesio taping
Medical subject headings
Breast Neoplasms, Myalgia, Arthralgia, Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular tapingDrug

    Also called Kinesio taping

    The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).

Study groups in NCT02406794
Study groupRoleWhat they receive
Neuromuscular tapingExperimentalThe first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).
Receives: Drug: Neuromuscular taping
No Kinesio tapingNo interventionNo Kinesio taping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical questionnaire

    A record will be kept of some medical data such as tumor grade, types carried, complementary treatments and end date, and the type of hormone therapy received and start date. The possible presence of comorbidities will also be collected.

    Genetic determinants. Analyze genetic determinants due to the importance of genetic background on AIA and abandonment of therapy (Garcia-Giralt N., 2013). Estrogen receptor 1 (ESR1), aromatase (CYP19A1) and steroid, 17-alpha-hydroxylase / 17,20 lyase (CYP17A1) (Garcia-Giralt N., 2013), (Henry NL, 2012) and (Mao JJ, 2011) have been selected as candidate genes.

    Samples for extracting genes will be collected in both cases with controls on the baseline and the end of it. The DNA is extracted from whole blood using the DNA Blood Maxi Qiafilter (Qiagen, Inc., Valencia, CA) (Henry NL, 2013) kit.

    Measured: 10 minutes

Secondary outcomes (11)
  1. Sociodemographic and anthropometric questionnaire

    This questionnaire will contain information on the following variables: gender and date of birth, marital status... Add basic anthropometric data such as weight, height, BMI, waist circumference and hip.

    Measured: 10 minutes

  2. Plasma proteins (or proteomic analysis)

    For our analysis investigators use four plasma proteins: serum amyloid A, collectin, immunoglobulin G (IgG) light chain kappa and add C1Q (Minton O., 2013).

    Measured: 10 minutes

  3. PPT

    The pain threshold pressure is defined as the minimum amount of pressure with which an initial feeling of pressure switches to pain. (Vanderweeën L. 1996). PPT measurements were performed on:

    • Cervical Musculature in space interapofisario C5-C6.
    • Lumbosacral Musculature: an L4 level on the erector spinae muscle.
    • Median nerve as it passes through the carpal bones.

    Measured: 10 minutes

  4. Grip strength as measured by a Dynamometer

    This instrument will be used to measure grip strength of both upper limbs. This test of strength has been previously used to measure the loss of strength in breast cancer survivors (Kaya T, 2010), even in cases where patients were treated with IAs (Lintermans A., 2011) . The dynamometer has proven to be the safest [ICC = 0.98] and most valid [ICC = 0.99] method to measure grip strength of the hand. (Bellace JV, 2000).

    Measured: 5 minutes

  5. POMS

    This is a scale to measure the profile of mood states. It consists of 65 items with five possible answers. The questionnaire delivered to patients is frequently used for study of breast cancer survivors (Cantarero-Villanueva, 2011). The reliability of the Spanish version of the POMS is high (Cronbach's α ranging from .76 to 0.91).

    Measured: 10 minutes

  6. quality of life as assessed by QuickPIPER questionnaire

    Tool used to determine the degree of perception that cancer patients have of their feelings of fatigue and how it alters their quality of life.

    This short version of the questionnaire proved to be adequate, with values of Kaiser-Meyer-Oklin (0.89) and Bartlett's sphericity test (P <0.001) index. The goodness of fit indices of confirmatory factor analysis are (normed fit index = 0.91 and = 0.92 comparative rate setting) satisfactory. The test-retest reliability of this questionnaire is very good (r = 0.947, P <0.001). (AI Cuesta-Vargas, 2013).

    Measured: 10 minutes

  7. EORTC QLQ-C30

    This is a specific questionnaire for cancer, "core", created by the EORTC Group. It consists of 30 items to assess HRQOL and physical, emotional, social status and overall functioning of patients diagnosed with cancer. The questions refer to the last week from the date on which the respondent completed the form. It is organised in several multi-item scales and some independent items. The reliability of the QLQ-C30 is adequate, with Cronbach Alpha values between 0.52 and 0.89 in different scales. (Moro D.,2011)

    Measured: 10 minutes

  8. pain as measured by VAS

    The Visual Analogue Scale (VAS) was designed to allow a subjective assessment of pain. A VAS is usually a horizontal line of 10 cm. with perpendicular lines at the ends, which are defined as the extreme limits of the painful experience. Previous studies have shown that the VAS has adequate psychometric properties, including test-retest reliability (r = 0.78) and convergent validity with other measures of pain such as the McGill Pain Questionnaire (r = 0.49 to 0.65) (Sriwatanakul K ., 1983).

    Measured: 10 minutes

  9. SFI-Sp

    For this study we will use the Spanish version (SFI-Sp), since it has proven to be a valid and reliable measure of the spinal region result. This regional tool reflects the status and any change in the kinetic chain of the spine. This questionnaire has demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96) (AI Cuesta-Vargas, 2014).

    Measured: 10 minutes

  10. ULFI-Sp

    This study uses the Spanish version (ULFI-Sp). This questionnaire has demonstrated high internal consistency (α = 0.94) and reliability (r = 0.93), making it a very useful tool for the evaluation of patients with disorders of the upper limbs, in both the clinical and research fields (AI Cuesta-Vargas, 2013).

    Measured: 10 minutes

  11. BADIX

    This Index includes a score for five movements of the trunk upright that result in Back Pain Index (BAI) and a record of "Morning Stiffness in the Back" (MBS). The sum of the BAI and MBS gives the BADIX (max. 20 points) (Kovacs FM, 2002).

    The BADIX appears to be a valid and reliable tool for the evaluation of morning stiffness restricting the mobility of the back, and discriminates whether the result of a treatment has been successful or not. (Farasyn A., 2013).

    This new Back Pain Disability index seems reliable (test-retest after 3 days) and is valid in the case of significant clinical change; it has also been shown to have discriminatory power and effect size comparable to other indices in assessing disability of patients with low back pain sensitivity. (Farasyn A., 2013).

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startMay 2016
  3. Primary completionSep 2016
  4. Study completionMar 2017

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406794
Sponsor's protocol ID
FCCSS-UMA_01-13
Acronym
KITMYCAN
Status last verified
Oct 2016
First submitted
30 Mar 2015
Last updated
31 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Conejo I, Pajares B, Alba E, Cuesta-Vargas AI. Effect of neuromuscular taping on musculoskeletal disorders secondary to the use of aromatase inhibitors in breast cancer survivors: a pragmatic randomised clinical trial. BMC Complement Altern Med. 2018 Jun 11;18(1):180. doi: 10.1186/s12906-018-2236-3.

    PubMed 29890985

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Neuromuscular taping in people with Breast Neoplasms, run by University of Malaga at 1 site in Spain.

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 8 inclusion and 0 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 31 Mar 2017. 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 Spain. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Medical questionnaire (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406794, which also lists 1 linked publication.

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 31 Mar 2017.

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