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

NCT05873829 | Completed

• 1 other identifier: E-50687469-929-1800
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Colorectal Cancer

Keywords

Colorectal cancer, Peripheral Neuropathies,Nursing

Outcome Measures

Primary Outcomes (4)

• 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

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

• Chemotheraphy induced peripheral neuropaty related Falls

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

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

• 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

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

• Chemotherapy Induced Peripheral Neuropathy Symptoms Assessment

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

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Hand-foot exercises were applied to the intervention group.

Other: Hand-foot exercises

Control Group

NO INTERVENTION

No intervention other than standard care was applied to the control group.

Interventions

Hand-foot exercises OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)
• 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.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gülhane Training and Resarch Hospital

Ankara, Ankara/Keçiören, 06010, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 25459280 BACKGROUND

• 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.

  PMID: 25261162 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 21444285 BACKGROUND

• 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.

  PMID: 17846553 BACKGROUND

• 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.

  PMID: 30888982 BACKGROUND

• 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.

  PMID: 29198853 BACKGROUND

• 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.

  PMID: 31876991 BACKGROUND

• 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.

  PMID: 38897103 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: April 25, 2022
• Primary Completion: July 5, 2022
• Study Completion: December 31, 2022
• Last Updated: August 22, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: Audiences of the research, pollsters, ethical committees and official authorities, researchers

Locations

TU (1)