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PolyneuropathiesRCTNCT07842237

Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy.

A study testing mechanical compression therapy and Exercises in people with Polyneuropathies and Regional Blood Flow, run by Damanhour University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Chemotherapy-induced peripheral neuropathy (CIPN) and impaired lower-limb circulation are common adverse effects that can compromise patients' mobility, comfort, balance, functional independence, and quality of life and may increase the risk of falls. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
mechanical compression therapy and Exercises
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
6 Sep 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult male and female patients aged 20-60 years who have been receiving chemotherapy for at least six months and who are willing to participate will be eligible for inclusion.

Who cannot join

  • Patients with uncontrolled diabetes mellitus or other medical conditions that may affect lower-limb perfusion or peripheral nerve function will be excluded.
  • Patients with burns or extensive wounds of the lower limbs will be excluded.
  • Patients with a lower-limb amputation will be excluded.
  • Patients receiving another physical, pharmacological, or mechanical treatment regimen directed at the lower limbs will be excluded.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Damanhour University

    Damanhūr, Damanhur

Other trials in Egypt

About this study

Official title: Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy

Chemotherapy-induced peripheral neuropathy (CIPN) and impaired lower-limb circulation are common adverse effects that can compromise patients' mobility, comfort, balance, functional independence, and quality of life and may increase the risk of falls. Although Buerger-Allen exercises and mechanical compression therapy are non-pharmacological approaches that may improve peripheral circulation and alleviate neuropathic symptoms, evidence directly comparing these interventions among patients receiving chemotherapy remains limited, particularly in Egypt. This study will address this gap and may inform feasible, nurse-led strategies for supportive oncology care.

Aim of the study:

Read more

This study will aim to compare the effects of Buerger-Allen exercises and mechanical compression therapy on lower-limb perfusion and peripheral neuropathy among patients undergoing chemotherapy.

Randomized control trail research design will be used. Setting The study will be conducted in the inpatient chemotherapy department at Ayady Almostakbal Cancer Treatment Hospital, Alexandria Governorate, Egypt. The hospital is a specialized, non-governmental, charitable medical center that provides cancer treatment services to residents of Alexandria Governorate and surrounding areas.

Subjects:

A purposive sample of 100 eligible patients will be recruited and allocated equally to two intervention groups: the Buerger-Allen exercise group (n = 50) and the mechanical compression therapy group (n = 50).

Inclusion criteria:

  • Adult male and female patients aged 20-60 years who have been receiving chemotherapy for at least six months and who are willing to participate will be eligible for inclusion.

Exclusion criteria:

  • Patients with uncontrolled diabetes mellitus or other medical conditions that may affect lower-limb perfusion or peripheral nerve function will be excluded.
  • Patients with burns or extensive wounds of the lower limbs will be excluded.
  • Patients with a lower-limb amputation will be excluded.
  • Patients receiving another physical, pharmacological, or mechanical treatment regimen directed at the lower limbs will be excluded.

Tools for data collection:

Two principal assessment tools will be used for data collection.

Tool 1: Lower-Limb Perfusion Assessment. This tool will be developed by the researchers following a comprehensive review of the relevant literature and will consist of three parts:

  • Part I: Patient Demographic Profile. This part will be used to collect data on age, gender, educational level, marital status, and occupation.
  • Part II: Clinical Data. This part will be used to assess the patient's past and current health history.
  • Part III: Lower-Limb Perfusion Assessment. This part will be adapted from Abouelala et al. (2022) Tool 2: Peripheral Neuropathy Assessment. This tool will be adapted from Abouelala et al. (2022) Proposed Study Procedures
  • The tools will be evaluated for content validity and relevance by a panel of five experts in medical-surgical nursing and oncology. Their recommendations will be considered when preparing the final versions.
  • A pilot study will be conducted with 10% of the calculated sample to assess the clarity, feasibility, and applicability of the study tools and procedures. Necessary modifications will be made accordingly. Participants included in the pilot study will be excluded from the main study sample and analyses.
  • Patients who meet the eligibility criteria will be allocated equally to the Buerger-Allen exercise group (n = 50) and the mechanical compression therapy group (n = 50).
  • Written informed consent will be obtained from each participant after the study purpose, intervention procedures, potential risks, and expected
Being tested
mechanical compression therapy, Exercises
Keywords
lower limb perfusion, peripheral Neuropathy, Chemotherapy
Medical subject headings
Polyneuropathies, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mechanical compression therapyDevice

    • Participants in Group 2 will receive mechanical compression therapy once during each chemotherapy session for one month, for a total of three sessions, with each session lasting 20 minutes.
  • ExercisesOther

    Buerger-Allen exercises. The researchers will explain and demonstrate the exercise and will ask each participant to return-demonstrate the following three steps:

    • Step 1-Elevation: The participant's lower extremities will be elevated to approximately 45° and supported in this position until blanching occurs, for approximately three minutes.
    • Step 2-Dependency: The participant's feet and legs will then be lowered below the level of the body until redness appears, for approximately 10 minutes.
    • Step 3-Horizontal rest: The participant's legs will be placed flat on the bed for 10 minutes.
    • The three-step Buerger-Allen exercise cycle will be repeated three times per session. Participants will be instructed to complete three sessions per day for five consecutive days, with performance monitored and reinforced by the researchers.
Study groups in NCT07842237
Study groupRoleWhat they receive
Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.ExperimentalBuerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.
Receives: Other: Exercises
Mechanical Compression TherapyExperimentalDevise
Receives: Device: mechanical compression therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lower-limb circumference measured using a non-stretch measuring tape

    Lower-limb circumference will be measured in centimeters using a non-stretch measuring tape at the mid-thigh, calf, and above the ankle of each lower limb. The same anatomical landmark and procedure will be used at every assessment. A lower circumference may indicate reduced swelling or edema. Right- and left-limb measurements will be recorded separately.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  2. Change in lower-limb skin temperature assessment by palpation using the back of the fingers

    Lower-limb skin temperature will be assessed by palpation using the back of the fingers. Measurements will be recorded separately for the right and left lower limbs.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  3. Change in lower-limb capillary refill time assessed by the blanching test

    Capillary refill time will be assessed by applying pressure to the distal toe until blanching occurs and measuring the time required for normal color to return after pressure is released. The result will be recorded in seconds. A shorter capillary refill time indicates better peripheral perfusion. Each lower limb will be assessed separately.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  4. Change in distal pedal pulse strength assessed using a standardized pulse-grading scale

    Dorsalis pedis and posterior tibial pulse strength will be assessed by palpation and graded as 0 = absent, 1 = weak, 2 = normal, and 3 = bounding. Higher scores indicate stronger palpable distal pulses. Each pulse site and lower limb will be documented separately.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  5. Change in lower-limb edema assessed using the pitting-edema grading scale

    Pitting edema will be assessed by applying standardized pressure over the lower limb and grading the resulting indentation using a 0-4+ scale, where 0 indicates no pitting edema and 1+ to 4+ indicate increasing severity. Higher scores indicate more severe edema. Each lower limb will be assessed separately.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  6. Change in active ankle dorsiflexion measured using a goniometer

    Active ankle dorsiflexion will be measured using a standard goniometer while the participant actively moves the ankle through the available range. The angle will be recorded separately for the right and left ankles. A greater angle indicates a greater active range of motion.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  7. Change in passive ankle dorsiflexion measured using a goniometer

    Passive ankle dorsiflexion will be measured using a standard goniometer while the assessor moves the participant's ankle through the available range without active effort from the participant. The angle will be recorded separately for the right and left ankles. A greater angle indicates a greater passive range of motion.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

Secondary outcomes (3)
  1. lower-limb sensation assessed using the adapted Peripheral Neuropathy Assessment Tool

    Lower-limb sensation will be assessed using the sensation component of the researcher-adapted Peripheral Neuropathy Assessment Tool based on Abouelala et al. (2022) including light touch, pinprick, vibration. Each lower limb will be assessed separately at prespecified anatomical sites using the standardized procedures and response categories defined in the finalized assessment tool. Sensation will be classified as intact or impaired. The outcome will be reported as the number of participants with impaired lower-limb sensation.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  2. lower-limb pain intensity assessed using the Numeric Rating Scale

    Participants will rate lower-limb pain intensity on a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain. If both limbs are painful, pain will be assessed separately for each limb or according to a prespecified rule identifying the most symptomatic limb.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

  3. lower-limb skin color assessed by standardized clinical inspection

    Lower-limb skin color will be assessed by standardized clinical inspection and classified using prespecified categories in the Lower-Limb Perfusion Assessment, such as normal color, pallor, cyanosis, or dependent rubor. The outcome will be reported as the number of participants in each category.

    Measured: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start6 Sep 2026
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07842237
Sponsor's protocol ID
University of Damanhour, Egypt
Acronym
RCT
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 1. Rao RD, Michalak JC. Chemotherapy-related toxicity in oncology practice. J Oncol Pract. 2018;14(2):89-96. 2. National Cancer Institute. Chemotherapy and you: support for people with cancer [Internet]. Bethesda (MD): National Institutes of Health; 2021 [cited 2026 Jun 18]. Available at: https://www.cancer.gov/ 3. Rahman N, Sukumar J, Maryam B. Chronic chemotherapy-induced peripheral neuropathy: living with neuropathy during and after cancer treatments. Ann Palliat Med. 2025;14(2). 4. Kruger-Genge A, Blocki A, Franke RP, Jung F. Vascular endothelial cell biology. Int J Mol Sci. 2019;20:4411. doi: 10.3390/ijms20184411 5. Starobova H, Vetter I. Pathophysiology of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2017;10:174. 6. Iorga RA, Bratu OG, Marcu RD, Constantin T, Mischianu DLD, Socea B, et al. Thromboembolism in cancer patients treated with chemotherapy-still a clinical concern. Cancers. 2019;18(6):5026-5032. doi: 10.3892/etm.2019.8019. 7. Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, et al. Long-term peripheral neuropathy in breast cancer patients treated with adjuvant chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018;110(2):djx162. 8. Zajączkowska R, Kocot-Kępska M, Leppert W, Wrzosek A, Mika J, Wordliczek J. Mechanisms of chemotherapy-induced peripheral neuropathy. Int J Mol Sci. 2019;20(6):1451. doi:10.3390/ijms20061451. 9. Gaballah A, Shafik A, Elhusseiny K, Ashraf M. Chemotherapy-induced peripheral neuropathy in Egyptian patients: single institution retrospective analysis. Asian Pac J Cancer Prev. 2018;19(8):2223-2227. doi: 10.22034/APJCP.2018.19.8.2223. 10. Health Promotion Administration, Ministry of Health and Welfare. Cancer Registry Annual Report 2020 [Internet]. 2020 [cited 2026 Jun 18]. Available at: https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=13498 11. Sarezky J, Sachs G, Elinzano H, Stavros K. Cancer and peripheral nerve disease. Clin Geriatr Med. 2021;37(2):289-300. 12. Sidhu D,

Questions about this trial

What is this clinical trial studying?

A study testing mechanical compression therapy and Exercises in people with Polyneuropathies and Regional Blood Flow, run by Damanhour University at 1 site 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 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in lower-limb circumference measured using a non-stretch measuring tape (time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion). The study lists 7 primary outcomes in all. 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 NCT07842237, 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 30 Sep 2026.

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