Breast Cancer LymphedemaNCT03401086
Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy
A study testing Kinesio Taping in people with Breast Cancer Lymphedema, run by Ahlia University at 2 sites in Egypt.
Trial summary
Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems This study aimed to… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Feb 2017to 1 Nov 2017
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side.
Who cannot join
- The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparison of Kinesiotaping and Pressure Garment on Old Adult Women With Secondary Upper Extremity Lymphedema Following Mastectomy: A Randomized Controlled Trial
Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems
This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer.
Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.
Read the detailed description
66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. The participants were randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio taping (KT) and pressure garment (PG) included 33 patients.
The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Kinesio Taping
- 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
Kinesio Taping
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Kinesio Taping Receives: Other: Kinesio Taping |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb circumference
The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.
Measured: 1 month
Secondary outcomes (3)
Shoulder Pain and Disability Index
Shoulder Pain and Disability Index (SPADI) survey was created to assess the shoulder pain and disability. It incorporates of 13 items that assess two domains: a 5 items that assess pain and an 8 items that evaluate disability.
Measured: 1 month
Hand grip strength
Hand grip strength was evaluated by Dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, United Kingdom). The grip strength was measured while the patient was in a standing position with adducted shoulder, flexed elbow 90 degrees and forearm in mid position.
Measured: 1 month
Quality of life
The quality of life was assessed by utilizing cancer-specific questionnaire (EORTC) QLQ-C30 before and after intervention. QLQ-C30 comprised of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start4 Feb 2017
- Primary completion7 Jun 2017
- Study completion1 Nov 2017
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahlia University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Dr Sayed Tantawy, Ahlia University
- Investigators
- Sayed A Tantawy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401086
- Sponsor's protocol ID
- Cairo University
- Status last verified
- Jan 2018
- First submitted
- 25 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tantawy SA, Abdelbasset WK, Nambi G, Kamel DM. Comparative Study Between the Effects of Kinesio Taping and Pressure Garment on Secondary Upper Extremity Lymphedema and Quality of Life Following Mastectomy: A Randomized Controlled Trial. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419847276. doi: 10.1177/1534735419847276.
PubMed 31068019
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kinesiotaping and Pressure Garment on Old Adult Women With Secondary Upper Extremity Lymphedema Following Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03401086
- Acronym / sponsor ID
- Cairo University
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ahlia UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 17 Jan 2018 (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 is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems
This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer.
Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.
Detailed description
66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. The participants were randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio taping (KT) and pressure garment (PG) included 33 patients.
The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Kinesio TapingKinesio Taping |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side.
Key exclusion criteria (1 listed)
- The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
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 TapingKinesio Taping | Other | Study group |
Primary outcome
Limb circumference
Time frame: 1 month
The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.
3 secondary outcomes
Shoulder Pain and Disability Index
Time frame: 1 month
Hand grip strength
Time frame: 1 month
Quality of life
Time frame: 1 month
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 17 Jan 2018.
- Derived from this study: PubMed 31068019Tantawy SA, Abdelbasset WK, Nambi G, Kamel DM. Comparative Study Between the Effects of Kinesio Taping and Pressure Garment on Secondary Upper Extremity Lymphedema and Quality of Life Following Mastectomy: A Randomized Controlled Trial. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419847276. doi: 10.1177/1534735419847276.
- 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.
Sayed A Tantawy study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping in people with Breast Cancer Lymphedema, run by Ahlia University at 2 sites in Egypt.
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 1 inclusion and 1 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Limb circumference (time frame: 1 month). 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 NCT03401086, 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 17 Jan 2018.