Clinical trial NCT02406794: Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors
Official title: Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Neoplasms
Keywords: Breast cancer
Hormonal therapy
Aromatase inhibitors
Estrogen deprivation
Myalgia
Arthralgia
Carpal tunnel syndrome
Pressure pain threshold
Neuromuscular taping
Kinesio taping
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Medical questionnaire
timeFrame: 10 minutes
Secondary outcomes:
measure: Sociodemographic and anthropometric questionnaire
timeFrame: 10 minutes
measure: Plasma proteins (or proteomic analysis)
timeFrame: 10 minutes
measure: PPT
timeFrame: 10 minutes
measure: Grip strength as measured by a Dynamometer
timeFrame: 5 minutes
measure: POMS
timeFrame: 10 minutes
measure: quality of life as assessed by QuickPIPER questionnaire
timeFrame: 10 minutes
measure: EORTC QLQ-C30
timeFrame: 10 minutes
measure: pain as measured by VAS
timeFrame: 10 minutes
measure: SFI-Sp
timeFrame: 10 minutes
measure: ULFI-Sp
timeFrame: 10 minutes
measure: BADIX
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Regional University Hospital Virgen de la Victoria
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta-Vargas, PhD
role: STUDY_DIRECTOR
affiliation: University of Malaga
name: Inmaculada Conejo-Tirado
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.