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Comparison of Techniques for Breast Cancer-Related Lymphedema.

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ClinicalTrials.gov Identifier: NCT03051750
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Information provided by (Responsible Party):
Violeta Pajero Otero, Hospital Universitario 12 de Octubre

Brief Summary:

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.

2. Kinesio Taping.


Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Other: Complex Physical Therapy plus Pressotherapy Other: Kinesio Taping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.
Primary Purpose: Treatment
Official Title: Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 21, 2016
Actual Study Completion Date : December 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CPT+P
Complex Physical Therapy plus Pressotherapy during three weeks
Other: Complex Physical Therapy plus Pressotherapy
Experimental: Kinesio Taping
Kinesio Taping during three weeks
Other: Kinesio Taping



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Score on the DASH Outcome Measure. [ Time Frame: Four weeks during each treatment phase ]
    Validated questionnaire about Disability of the Arm,Shoulder and Hand.

  2. Score of the TTDL questionnaire. [ Time Frame: Four weeks during each treatment phase ]
    a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).

  3. Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS). [ Time Frame: Four weeks during each treatment phase ]
    Wong-Baker faces pain rating scale.

  4. Stage of the lymphedema. [ Time Frame: Four weeks during each treatment phase ]
    I, IIA, IIB III, IV.

  5. Goniometry of Upper Limb. [ Time Frame: Four weeks during each treatment phase ]
    Goniometry of shoulder, elbow and wrist.

  6. Body Mass Index. [ Time Frame: Four weeks during each treatment phase ]
    The weight in kilograms divided by the square of the height in metres (kg/m2).


Other Outcome Measures:
  1. Age. [ Time Frame: First day of treatment of the first phase. ]
    Years old at the beginning of the study.

  2. Time since axillary surgery. [ Time Frame: First day of treatment of the first phase. ]
    Time since axillary surgery in years at the beginning of the study.

  3. Type of axillary surgery. [ Time Frame: First day of treatment of the first phase. ]
    Lymphadenectomy or Sentinel Lymph Node Biopsy.

  4. Type of breast surgery. [ Time Frame: First day of treatment of the first phase. ]
    Lumpectomy or mastectomy.

  5. Radiotherapy for Breast Cancer. [ Time Frame: First day of treatment of the first phase. ]
    Yes or not.

  6. Time since the appearance of the BCRL. [ Time Frame: First day of treatment of the first phase. ]
    Years since the BCRL appeared.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Submit BCRL
  2. Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.
  3. Signing the informed consent.

Exclusion Criteria:

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051750


Locations
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Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Violeta Pajero Otero
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Investigators
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Principal Investigator: Violeta Pajero Otero, MRes Hospital Universitario 12 de Octubre

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Responsible Party: Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT03051750     History of Changes
Other Study ID Numbers: InveCuidRh150316
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Violeta Pajero Otero, Hospital Universitario 12 de Octubre:
Breast Cancer-Related Lymphedema
Complex Physical Therapy
Pressotherapy
Kinesio Taping
Physiotherapy
Manual Lymph Drainage
Multilayer Bandage
TTDL questionnaire

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes