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Chemotherapy-induced Peripheral NeuropathyNCT05873829

Hand-Foot Exercises for Chemotheraphy Induced Peripheral Neuropathy Pain, Falls and Quality of Life in Colorectal Cancer

A study testing Hand-foot exercises in people with Chemotherapy-induced Peripheral Neuropathy and Colorectal Cancer, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Colorectal cancer is the 4th most common cancer in the world among all cancer types. Chemotherapy-induced peripheral neuropathy is a common and serious side effect caused by chemotherapeutic agents, especially platinum analogues, taxanes, vinca alkaloids and bortezomib. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hand-foot exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Apr 2022to 31 Dec 2022
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being 18 years or older.
  • Not having any physical or mental health problems that will prevent communication.
  • Being conscious and cooperative.
  • Being diagnosed with colorectal cancer.
  • Receiving 2, 3, 4, 5, 6 or 7 cycles of platinum-based chemotherapy.
  • Being treated with the FOLFOX regimen.
  • Having chemotherapy-induced peripheral neuropathy according to CIPNAT (Chemotherapy-Induced Peripheral Neuropathy Assessment Tool). (Answering "yes" to the first 4 questions)
  • Agree to participate in the research.

Who cannot join

  • Receiving less than 2 cycles of platinum-based therapy.
  • To be receiving platinum-based treatment at 8th cycle and above.
  • Being diagnosed with a chronic disease (diabetes) that can lead to peripheral neuropathy.
  • Experiencing neuropathic symptoms due to cervical or lumbar hernia.
  • Having a habit of using alcohol constantly.
  • Being on medication that masks neuropathy signs or may develop neuropathy symptoms. (Opioid, beta blocker, anticonvulsant, tricyclic antidepressant etc.)
Show all 15Show fewer
  • Having previously received neurotoxic chemotherapy (such as taxane, vinca alkaloids, bortezomib).
  • To have had major surgery in the last 1 month.
  • Not having the physical and mental ability to complete the research.
  • Refusing to participate in the research. Drop out Criteria
  • Changing the chemotherapy protocol.
  • Not being able to apply the Hand-Foot Exercises Program regularly.
  • Indicate that they want to withdraw from the research while the research is in progress.
  • Not being reached while the research is in progress.
  • Losing life while research is in progress.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gülhane Training and Resarch Hospital

    Ankara, Ankara/Keçiören, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Hand-Foot Exercises on Platinum-Based Chemotheraphy Induced Peripheral Neuropathy Related Pain Severity, Falls and Quality of Life in Colorectal Cancer

Colorectal cancer is the 4th most common cancer in the world among all cancer types. Chemotherapy-induced peripheral neuropathy is a common and serious side effect caused by chemotherapeutic agents, especially platinum analogues, taxanes, vinca alkaloids and bortezomib. The most commonly used chemotherapeutic agents in the treatment of colorectal cancers are platinum analogues It is known that oxaliplatin, one of the platinum analogues, causes 85-96% of chemotherapy-induced peripheral neuropathy. The most common symptoms of chemotherapy-induced peripheral neuropathy are; numbness, paresthesia, dysesthesia, pain, hypersensitivity to cold or heat, tingling, muscle cramps, distal weakness, gait disturbances, balance disorders, and impaired movement. Oxaliplatin, which is frequently used in the treatment of colorectal cancer, causes symptoms of both acute and chronic chemotherapy-induced peripheral neuropathy. There is no proven method in the treatment of chemotherapy-induced peripheral neuropathy. However, various pharmacological and non-pharmacological approaches are applied in its preventive and symptomatic treatment. Exercise and physical therapy interventions; It is stated that it improves strength, balance and other functional disorders in patients, reduces symptoms, and reduces the risk of falling by affecting gross motor dysfunctions such as balance and gait abnormalities. However, the limitations of studies on this subject in the literature draw attention. This situation suggests that new methods that can be applied in the care of cancer patients who develop peripheral neuropathy due to chemotherapy should be developed in the field of nursing. This research is the first study to evaluate the effect of hand-foot exercises on colorectal cancer patients who developed peripheral neuropathy due to platinum-based therapy. Research results; Alleviation of KBPN-induced pain and prevention of falls are important in terms of increasing the quality of life of patients and providing evidence for nursing practices by using it as a new method that can be applied in the care of cancer patients with chemotherapy-induced peripheral neuropathy. The aim of this research was to determine the effect of hand-foot exercises on the severity of pain, falls and quality of life associated with platinum-based therapy-related peripheral neuropathy in patients with colorectal cancer.

Read the detailed description

Aim of the study:This study was conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity, falls and quality of life in patients with colorectal cancer.

Design of the study:The research is a randomized controlled experimental study conducted to determine the effect of hand-foot exercises on platinum-based therapy-related peripheral neuropathy-related pain severity, falls and quality of life in patients with colorectal cancer.

Study place and date:The research was carried out in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit. Research data were collected between 25 April and 31 December 2022.

Sample and setting:The population of the study consists of patients diagnosed with colorectal cancer who received platinum-based treatment in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31, 2022. The sample of the study consists of patients who were diagnosed with colorectal cancer in Gülhane Training and Research Hospital Medical Oncology Outpatient Chemotherapy Unit between April 25 and December 31, 2022, received at least 2 and maximum 7 cycles of platinum-based chemotherapy and accepted to participate in the study.

Measuraments:Research data were collected with Sociodemographic and Clinical Characteristics Form, Exercise Follow-up Form, EORTC QLQ-C30 scale, EORTC QLQ-CR29 scale, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, Numerical Pain Rating Scale, Fall Status Follow-up Form.

Ethical considerations:Ethics committee approval was obtained from Ankara University Ethics Committee for the conduct of the study. Institutional permission was obtained from Gülhane Training and Research Hospital, the institution where the research was conducted.Verbal and written informed consent was obtained from the patients who agreed to participate in the study.

Being tested
Hand-foot exercises
Keywords
Colorectal cancer, Peripheral Neuropathies,Nursing
Medical subject headings
Colorectal Neoplasms, Peripheral Nervous System Diseases

What participants receive

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

  • Hand-foot exercisesOther

    Hand-foot exercise program consists of 5 hand and 5 foot exercises, and a total of 15 minutes of simple hand-foot exercises. The exercise program is applied 3 times a day, 3 days a week. The tennis ball and the towel that used in the exercise program, the booklet which containing the exercise explanations and the video link showing the implementation of the exercises were provided by the researcher.

Study groups in NCT05873829
Study groupRoleWhat they receive
Intervention GroupExperimentalHand-foot exercises were applied to the intervention group.
Receives: Other: Hand-foot exercises
Control GroupNo interventionNo intervention other than standard care was applied to the control group.

What is being measured

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

  1. Chemotheraphy induced peripheral neuropaty related Pain Severity

    Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related pain severtiy- Numeric Pain Rating Scale

    Measured: 0. week (begining of the study) - 8. week (end of the study)

  2. Chemotheraphy induced peripheral neuropaty related Falls

    Hand-foot exercise program effects on platiunum based chemotheraphy induced peripheral neuropathy related falls-Fall Follow-up Form

    Measured: 0. week (begining of the study) - 8. week (end of the study)

  3. Colorectal cancer patient's Quality of Life

    Hand-foot exercise program effects on quality of life of patients-EORTC QLQ-C30, EORTC QLQ-CR29 scales

    Measured: 0. week (begining of the study) - 8. week (end of the study)

  4. Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment

    Hand-foot exercise program effects on chemotheraphy induced peripheral neuropathy symptoms- CIPNAT tool

    Measured: 0. week (begining of the study) - 8. week (end of the study)

Timeline

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

  1. First posted24 May 2023
  2. Study start25 Apr 2022
  3. Primary completion5 Jul 2022
  4. Study completion31 Dec 2022

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
Model description
The patients, whose written and verbal consents were obtained in accordance with the inclusion criteria, were randomly assigned to the intervention and control groups. Hand-foot exercises were applied to the patients in the intervention group. The patients in the control group did not undergo any intervention other than standard care.
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05873829
Sponsor's protocol ID
E-50687469-929-1800
Status last verified
May 2023
First submitted
16 May 2023
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is not a plan to make individual participant data (IPD) available to other researchers.

Publications

  • Carozzi VA, Canta A, Chiorazzi A. Chemotherapy-induced peripheral neuropathy: What do we know about mechanisms? Neurosci Lett. 2015 Jun 2;596:90-107. doi: 10.1016/j.neulet.2014.10.014. Epub 2014 Oct 22.

    PubMed 25459280
  • Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

    PubMed 25261162
  • Tofthagen CS, McMillan SC, Kip KE. Development and psychometric evaluation of the chemotherapy-induced peripheral neuropathy assessment tool. Cancer Nurs. 2011 Jul-Aug;34(4):E10-20. doi: 10.1097/NCC.0b013e31820251de.

    PubMed 21242773
  • Colvin LA. Chemotherapy-induced peripheral neuropathy: where are we now? Pain. 2019 May;160 Suppl 1(Suppl 1):S1-S10. doi: 10.1097/j.pain.0000000000001540.

    PubMed 31008843
  • Burgess J, Ferdousi M, Gosal D, Boon C, Matsumoto K, Marshall A, Mak T, Marshall A, Frank B, Malik RA, Alam U. Chemotherapy-Induced Peripheral Neuropathy: Epidemiology, Pathomechanisms and Treatment. Oncol Ther. 2021 Dec;9(2):385-450. doi: 10.1007/s40487-021-00168-y. Epub 2021 Oct 16.

    PubMed 34655433
  • Addington J, Freimer M. Chemotherapy-induced peripheral neuropathy: an update on the current understanding. F1000Res. 2016 Jun 22;5:F1000 Faculty Rev-1466. doi: 10.12688/f1000research.8053.1. eCollection 2016.

    PubMed 27408692
  • Kaley TJ, Deangelis LM. Therapy of chemotherapy-induced peripheral neuropathy. Br J Haematol. 2009 Apr;145(1):3-14. doi: 10.1111/j.1365-2141.2008.07558.x. Epub 2009 Jan 16.

    PubMed 19170681
  • Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.

    PubMed 27183099
  • Tofthagen C, Overcash J, Kip K. Falls in persons with chemotherapy-induced peripheral neuropathy. Support Care Cancer. 2012 Mar;20(3):583-9. doi: 10.1007/s00520-011-1127-7. Epub 2011 Mar 5.

    PubMed 21380613
  • Tofthagen C, McAllister RD, McMillan SC. Peripheral neuropathy in patients with colorectal cancer receiving oxaliplatin. Clin J Oncol Nurs. 2011 Apr;15(2):182-8. doi: 10.1188/11.CJON.182-188.

    PubMed 21444285
  • Bakitas MA. Background noise: the experience of chemotherapy-induced peripheral neuropathy. Nurs Res. 2007 Sep-Oct;56(5):323-31. doi: 10.1097/01.NNR.0000289503.22414.79.

    PubMed 17846553
  • Dhawan S, Andrews R, Kumar L, Wadhwa S, Shukla G. A Randomized Controlled Trial to Assess the Effectiveness of Muscle Strengthening and Balancing Exercises on Chemotherapy-Induced Peripheral Neuropathic Pain and Quality of Life Among Cancer Patients. Cancer Nurs. 2020 Jul/Aug;43(4):269-280. doi: 10.1097/NCC.0000000000000693.

    PubMed 30888982
  • Duregon F, Vendramin B, Bullo V, Gobbo S, Cugusi L, Di Blasio A, Neunhaeuserer D, Zaccaria M, Bergamin M, Ermolao A. Effects of exercise on cancer patients suffering chemotherapy-induced peripheral neuropathy undergoing treatment: A systematic review. Crit Rev Oncol Hematol. 2018 Jan;121:90-100. doi: 10.1016/j.critrevonc.2017.11.002. Epub 2017 Nov 7.

    PubMed 29198853
  • Win MMTM, Fukai K, Nyunt HH, Linn KZ. Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial. Nurs Health Sci. 2020 Jun;22(2):416-426. doi: 10.1111/nhs.12676. Epub 2019 Dec 26.

    PubMed 31876991
  • Eroglu I, Kutluturkan S. The effect of hand-foot exercises on chemotherapy-induced peripheral neuropathy-related pain, falls, and quality of life in colorectal cancer: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102641. doi: 10.1016/j.ejon.2024.102641. Epub 2024 Jun 15.

    PubMed 38897103

Questions about this trial

What is this clinical trial studying?

A study testing Hand-foot exercises in people with Chemotherapy-induced Peripheral Neuropathy and Colorectal Cancer, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).

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 8 inclusion and 15 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 22 Aug 2025. 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 Turkey (Türkiye). 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?

Chemotheraphy induced peripheral neuropaty related Pain Severity (time frame: 0. week (begining of the study) - 8. week (end of the study)). The study lists 4 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 NCT05873829, which also lists 15 linked publications.

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 22 Aug 2025.

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