NCT02406794

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 31, 2017

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

March 30, 2015

Last Update Submit

March 30, 2017

Conditions

Breast Neoplasms

Keywords

Breast cancerHormonal therapyAromatase inhibitorsEstrogen deprivationMyalgiaArthralgiaCarpal tunnel syndromePressure pain thresholdNeuromuscular tapingKinesio taping

Outcome Measures

Primary Outcomes (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.

    10 minutes

Secondary Outcomes (11)

  • Sociodemographic and anthropometric questionnaire

    10 minutes

  • Plasma proteins (or proteomic analysis)

    10 minutes

  • PPT

    10 minutes

  • Grip strength as measured by a Dynamometer

    5 minutes

  • POMS

    10 minutes

  • +6 more secondary outcomes

Study Arms (2)

Neuromuscular taping

EXPERIMENTAL

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).

Drug: Neuromuscular taping

No Kinesio taping

NO INTERVENTION

No Kinesio taping

Interventions

Neuromuscular tapingDRUG

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).

Also known as: Kinesio taping
Neuromuscular taping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional University Hospital Virgen de la Victoria

Málaga, Malaga, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29890985DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMyalgiaArthralgiaCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Antonio I Cuesta-Vargas, PhD

    University of Malaga

    STUDY DIRECTOR

  • Inmaculada Conejo-Tirado

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Faculty of Health Sciences

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

March 31, 2017

Record last verified: 2016-10

Locations

ES(1)