Breast NeoplasmsNCT06327438
Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial
A study testing Complex decongestive therapy, Cryotherapy and Kinesio taping in people with Breast Neoplasms, run by South Valley University at 2 sites in Egypt.
Trial summary
To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Complex decongestive therapy, Cryotherapy and Kinesio taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Mar 2024to 16 Jul 2024
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 40 to 60 years. They were grade 2 and 3 lymphedema. They had more than 2 cm difference at circumference measurement. They had unilateral arm lymphedema post-mastectomy. They had completed chemotherapy and radiotherapy.
Who cannot join
- Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ragaee Saeed Mahmoud
Faisal, Giza Governorate, 002
Reham Saeed, Doctora, 00201223611112, rsm_Pt211@yahoo.com
Rabab Saeed, Doctora, 00201017855222, rababSaeed10@yahoo.com
- Recruiting
Ragaee Saeed Mahmoud
Giza, Faisal
Ragaee Mahmoud, 00201223611112, ragaeesaeedpt10@gmail.com
Reham Mahmoud, 00201015447798, rsm_211pt@yahoo.com
About this study
Official title: Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema
To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema
Read the detailed description
Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B \& C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT
- Conditions
- Breast Neoplasms
- Being tested
- Complex decongestive therapy, Cryotherapy, Kinesio taping
- Keywords
- Complex Decongestive Therapy; Cryotherapy; Kinesio Taping; Lymphedema; Post-mastectomy
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex decongestive therapyOther
- Manual lymphatic drainage (MLD).
- Compression bandage.
- Exercises to enhance lymphatic drainage.
- Skin care.
CryotherapyDevice
It is a mature and safe-to-use system that cools the air to -32°C. Steps of application included: 1) Apply oil or cream to moisture the skin before cryotherapy application; 2) Initialize the mini cryo-air equipment at level 6.
Kinesio tapingOther
It is a new choice in the field of physical therapy. The material used for the KT and the original concept of the taping technique were introduced by Dr Kenso Kase in 1973.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | (n=20) received complex decongestive therapy only Receives: Other: Complex decongestive therapy |
| Group (B) | Experimental | (n=20) received cryotherapy and complex decongestive therapy Receives: Other: Complex decongestive therapy; Device: Cryotherapy |
| Group (C) | Experimental | (n=20) received kinesio taping and complex decongestive therapy Receives: Other: Complex decongestive therapy; Other: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm girth measurement is measured by Circumferential measurements
It is a valid and reliable method, its protocol was used throughout, with measures performed on both arms at the axilla, halfway from the axilla to the cubital fossa, cubital fossa, halfway from the cubital fossa to the wrist, and at the wrist.
Measured: 12 consecutive weeks
Pain severity is measured by VAS
It consisted of a line, often 10 cm long (100 mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be")
Measured: 12 consecutive weeks
Secondary outcomes (2)
The QOL is measured by SF-36
It is widely validated and popularly method that is used to evaluate QOL of the patients. Since then, the reliability and validity of the SF-36 questionnaire have been evaluated in a number of specific population world-wide
Measured: 12 consecutive weeks
Range of motion (ROM) is measured by UG
It is GONIO_PLASTIC_360, China, frequently used for measurement of shoulder ROM (flexion, abduction and external rotation) by physical therapists to assess ROM due to its ease of use, portability, noninvasive nature, and low cost
Measured: 12 consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start16 Mar 2024 (estimated)
- Primary completion16 Jun 2024 (estimated)
- Study completion16 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Model description
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaee Saeed Mahmoud, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327438
- Sponsor's protocol ID
- REC/211/MTI.PT/2401041
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Intervention
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT06327438
- Acronym / sponsor ID
- REC/211/MTI.PT/2401041
- Conditions
- Breast Neoplasms
- Keywords
- Complex Decongestive Therapy; Cryotherapy; Kinesio Taping; Lymphedema; Post-mastectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 16 Mar 2024 (estimated)
- Primary completion
- 16 Jun 2024 (estimated)
- Study completion
- 16 Jul 2024 (estimated)
- First posted
- 25 Mar 2024 (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.
To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema
Detailed description
Sixty women diagnosed clinically by physician as post-mastectomy lymphedema, suffered from grade 2 and 3 lymphedema based on clinical investigations and their ages between 40 and 60 years were randomly assigned in single pre - post measurement study. They divided randomly into three groups of equal size (A, B \& C). The three groups received CDT program, group (A) (n=20) received CDT only, group (B) (n=20) received cryotherapy and group (C) (n=20) received KT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: Complex decongestive therapy(n=20) received complex decongestive therapy only |
| Group (B) | Experimental | Other: Complex decongestive therapy, Device: Cryotherapy(n=20) received cryotherapy and complex decongestive therapy |
| Group (C) | Experimental | Other: Complex decongestive therapy, Other: Kinesio taping(n=20) received kinesio taping and complex decongestive therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged between 40 to 60 years. They were grade 2 and 3 lymphedema. They had more than 2 cm difference at circumference measurement. They had unilateral arm lymphedema post-mastectomy. They had completed chemotherapy and radiotherapy.
Key exclusion criteria (1 listed)
- Skin infection. Current ischemia. Systemic edema due to impaired heart, kidney and liver function. Current metastases. Venous thrombosis.
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 decongestive therapy1. Manual lymphatic drainage (MLD). 2. Compression bandage. 3. Exercises to enhance lymphatic drainage. 4. Skin care. | Other | Group (A), Group (B), Group (C) |
| CryotherapyIt is a mature and safe-to-use system that cools the air to -32°C. Steps of application included: 1) Apply oil or cream to moisture the skin before cryotherapy application; 2) Initialize the mini cryo-air equipment at level 6. | Device | Group (B) |
| Kinesio tapingIt is a new choice in the field of physical therapy. The material used for the KT and the original concept of the taping technique were introduced by Dr Kenso Kase in 1973. | Other | Group (C) |
Primary outcome
Arm girth measurement is measured by Circumferential measurements
Time frame: 12 consecutive weeks
It is a valid and reliable method, its protocol was used throughout, with measures performed on both arms at the axilla, halfway from the axilla to the cubital fossa, cubital fossa, halfway from the cubital fossa to the wrist, and at the wrist.
Pain severity is measured by VAS
Time frame: 12 consecutive weeks
It consisted of a line, often 10 cm long (100 mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be")
2 secondary outcomes
The QOL is measured by SF-36
Time frame: 12 consecutive weeks
Range of motion (ROM) is measured by UG
Time frame: 12 consecutive weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No. Intervention
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex decongestive therapy, Cryotherapy and Kinesio taping in people with Breast Neoplasms, run by South Valley 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm girth measurement is measured by Circumferential measurements (time frame: 12 consecutive weeks). The study lists 2 primary outcomes in all. 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 25 Mar 2024.