Breast Cancer LymphedemaNCT03051750
Comparison of Techniques for Breast Cancer-Related Lymphedema.
A study testing Complex Physical Therapy plus Pressotherapy and Kinesio Taping in people with Breast Cancer Lymphedema, run by Violeta Pajero Otero at 1 site in Spain.
Trial summary
This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy. 2. Kinesio Taping. 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?
- Complex Physical Therapy plus Pressotherapy and Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2016to 21 Dec 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
- Submit BCRL
- Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
- Signing the informed consent.
Who cannot join
- 1) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.
- 7) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.
- Kinesio Taping.
Read the detailed description
Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.
Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.
GOALS:
Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.
Secondary objectives:
To analyze possible changes after each therapy in:
- DASH (Disability Arm, Shoulder and Hand) outcome measure score.
- TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
- Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
- Goniometry of Upper Limb.
METHODOLOGY OF THE STUDY:
Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.
Interventions: The two therapies compared are:
- CPT+ P.
- KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Complex Physical Therapy plus Pressotherapy, Kinesio Taping
- Keywords
- Breast Cancer-Related Lymphedema, Complex Physical Therapy, Pressotherapy, Kinesio Taping, Physiotherapy, Manual Lymph Drainage, Multilayer Bandage, TTDL questionnaire
- 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.
Complex Physical Therapy plus PressotherapyOther
Kinesio TapingOther
| Study group | Role | What they receive |
|---|---|---|
| CPT+P | Active comparator | Complex Physical Therapy plus Pressotherapy during three weeks Receives: Other: Complex Physical Therapy plus Pressotherapy |
| Kinesio Taping | Experimental | Kinesio Taping during three weeks Receives: Other: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
Truncated Cone Formula for Volume from upper limb circumference.
Measured: Four weeks during each treatment phase
Secondary outcomes (6)
Score on the DASH Outcome Measure.
Validated questionnaire about Disability of the Arm,Shoulder and Hand.
Measured: Four weeks during each treatment phase
Score of the TTDL questionnaire.
a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).
Measured: Four weeks during each treatment phase
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
Stage of the lymphedema.
I, IIA, IIB III, IV.
Measured: Four weeks during each treatment phase
Goniometry of Upper Limb.
Goniometry of shoulder, elbow and wrist.
Measured: Four weeks during each treatment phase
Body Mass Index.
The weight in kilograms divided by the square of the height in metres (kg/m2).
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 start1 Feb 2016
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin. Interventions: The two therapies compared are: * CPT+ P. * KT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 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
- NCT03051750
- Sponsor's protocol ID
- InveCuidRh150316
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pajero Otero V, Garcia Delgado E, Martin Cortijo C, Rodriguez Ramos ML, De Carlos Iriarte E, Gil Garcia A, Romay-Barrero H, Avendano-Coy J. Intensive complex physical therapy combined with intermittent pneumatic compression versus Kinesio taping for treating breast cancer-related lymphedema of the upper limb: A randomised cross-over clinical trial. Eur J Cancer Care (Engl). 2022 Sep;31(5):e13625. doi: 10.1111/ecc.13625. Epub 2022 May 31.
PubMed 35642305
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT03051750
- Acronym / sponsor ID
- InveCuidRh150316
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Breast Cancer-Related Lymphedema, Complex Physical Therapy, Pressotherapy, Kinesio Taping, Physiotherapy, Manual Lymph Drainage, Multilayer Bandage, TTDL questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Violeta Pajero OteroUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, University of Castilla-La Mancha
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 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.
This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.
- Kinesio Taping.
Detailed description
Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.
Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.
GOALS:
Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.
Secondary objectives:
To analyze possible changes after each therapy in:
- DASH (Disability Arm, Shoulder and Hand) outcome measure score.
- TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
- Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
- Goniometry of Upper Limb.
METHODOLOGY OF THE STUDY:
Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.
Interventions: The two therapies compared are:
- CPT+ P.
- KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin. Interventions: The two therapies compared are: * CPT+ P. * KT.
| Arm | Type | Receives |
|---|---|---|
| CPT+P | Active comparator | Other: Complex Physical Therapy plus PressotherapyComplex Physical Therapy plus Pressotherapy during three weeks |
| Kinesio Taping | Experimental | Other: Kinesio TapingKinesio Taping during three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Submit BCRL
- Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
- Signing the informed consent.
Key exclusion criteria (2 listed)
- 1) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.
- 7) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).
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 |
|---|---|---|
| Complex Physical Therapy plus Pressotherapy | Other | CPT+P |
| Kinesio Taping | Other | Kinesio Taping |
Primary outcome
Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
Time frame: Four weeks during each treatment phase
Truncated Cone Formula for Volume from upper limb circumference.
6 secondary outcomes
Score on the DASH Outcome Measure.
Time frame: Four weeks during each treatment phase
Score of the TTDL questionnaire.
Time frame: Four weeks during each treatment phase
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
Time frame: Four weeks during each treatment phase
Stage of the lymphedema.
Time frame: Four weeks during each treatment phase
Goniometry of Upper Limb.
Time frame: Four weeks during each treatment phase
Body Mass Index.
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 15 Feb 2019.
- Derived from this study: PubMed 35642305Pajero Otero V, Garcia Delgado E, Martin Cortijo C, Rodriguez Ramos ML, De Carlos Iriarte E, Gil Garcia A, Romay-Barrero H, Avendano-Coy J. Intensive complex physical therapy combined with intermittent pneumatic compression versus Kinesio taping for treating breast cancer-related lymphedema of the upper limb: A randomised cross-over clinical trial. Eur J Cancer Care (Engl). 2022 Sep;31(5):e13625. doi: 10.1111/ecc.13625. Epub 2022 May 31.
- 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 Complex Physical Therapy plus Pressotherapy and Kinesio Taping 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 3 inclusion and 2 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 15 Feb 2019. 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?
Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment. (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?
On the ClinicalTrials.gov record for NCT03051750, 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 15 Feb 2019.