Breast Cancer LymphedemaNCT03051776
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema
A study testing Kinesio Taping and Compression Garment in people with Breast Cancer Lymphedema, run by Violeta Pajero Otero at 1 site in Spain.
Trial summary
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Kinesio Taping and Compression Garment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jan 2016to 30 Mar 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.
- Having a Compression Garment suitable for the lymphedema arm
Who cannot join
- Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
- Metastasis breast cancer or other tumour.
- Treated with systemic chemotherapy and /or radiotherapy at that time
- Heart Failure or Renal Failure.
- Using Diuretics.
- Bilateral axillary lymphadenectomy.
- Cognitive impairment or delay that impedes understanding the study's instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.
Read the detailed description
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.
Research design:
Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.
Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.
Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Kinesio Taping, Compression Garment
- Keywords
- Compression garments, Kinesio Taping, Breast Cancer-Related Lymphedema
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
Compression GarmentOther
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping | Experimental | It was done a four week phase with Kinesio Taping in the arm affected with lymphedema. Receives: Other: Kinesio Taping |
| Compression garment | Active comparator | It was done a four week phase with Compression garment in the arm affected with lymphedema. Receives: Other: Compression Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated volumen of the upper limb.
Truncated Cone Formula.
Measured: Four weeks during each treatment phase
Secondary outcomes (2)
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
Wong-Baker faces pain rating scale.
Measured: Four weeks during each treatment phase
Goniometry of Upper Limb.
Goniometry of shoulder, elbow, wrist and hand.
Measured: Four weeks during each treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start3 Jan 2016
- Primary completion30 Mar 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two treatmet phases, with a four week wash out period bewtween them: * A four week phase with Kinesio Taping * A four week phase with compression garments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Violeta Pajero Otero
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, University of Castilla-La Mancha
- Responsible party
- Sponsor-investigator, Violeta Pajero Otero, Hospital Universitario 12 de Octubre
- Investigators
- Violeta Pajero Otero, MRes, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051776
- Sponsor's protocol ID
- InveCuidRhKM
- Status last verified
- Oct 2017
- First submitted
- 8 Feb 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT03051776
- Acronym / sponsor ID
- InveCuidRhKM
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Compression garments, Kinesio Taping, Breast Cancer-Related Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Violeta Pajero OteroUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, University of Castilla-La Mancha
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 14 Feb 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.
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.
Detailed description
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.
Research design:
Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.
Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.
Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two treatmet phases, with a four week wash out period bewtween them: * A four week phase with Kinesio Taping * A four week phase with compression garments.
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Experimental | Other: Kinesio TapingIt was done a four week phase with Kinesio Taping in the arm affected with lymphedema. |
| Compression garment | Active comparator | Other: Compression GarmentIt was done a four week phase with Compression garment in the arm affected with lymphedema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.
- Having a Compression Garment suitable for the lymphedema arm
Key exclusion criteria (7 listed)
- Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
- Metastasis breast cancer or other tumour.
- Treated with systemic chemotherapy and /or radiotherapy at that time
- Heart Failure or Renal Failure.
- Using Diuretics.
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 |
|---|---|---|
| Kinesio Taping | Other | Kinesio Taping |
| Compression Garment | Other | Compression garment |
Primary outcome
Estimated volumen of the upper limb.
Time frame: Four weeks during each treatment phase
Truncated Cone Formula.
2 secondary outcomes
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
Time frame: Four weeks during each treatment phase
Goniometry of Upper Limb.
Time frame: Four weeks during each treatment phase
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 Oct 2017.
- 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.
Violeta Pajero Otero, MRes principal investigator
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping and Compression Garment in people with Breast Cancer Lymphedema, run by Violeta Pajero Otero 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 2 inclusion and 7 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 Oct 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.
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?
Estimated volumen of the upper limb. (time frame: Four weeks during each treatment phase). 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 Oct 2017.