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Peripheral Neuropathy Due to ChemotherapyNCT07203066

Effects of Oxaliplatin-Induced Peripheral Neuropathy on Hand Function, Grip Strength and Quality of Life in Colorectal Cancer Patients

An observational study of Peripheral Neuropathy Due to Chemotherapy and Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, run by Fenerbahce University 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

The aim of this study is to investigate the effects of oxaliplatin-induced peripheral neuropathy on hand function, grip strength, and quality of life in colorectal cancer patients. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
observational only
How many people
103 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Apr 2025to 27 Jan 2026
Phase
Observational
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: colorectal cancer patients who received oxaliplatin based chemotherapy

Who may be able to join

  • Receiving chemotherapy due to a diagnosis of locally advanced or metastatic colorectal cancer,
  • Having received at least 3 cycles of single or combined oxaliplatin-based chemotherapy,
  • Aged 20 years or older,
  • No speech or hearing impairments,
  • Voluntary participation in the study.

Who cannot join

  • Development of peripheral neuropathy due to causes other than chemotherapy (e.g., tumor compression, nutritional disorders, infections, or major systemic diseases such as diabetes mellitus),
  • Presence of mental or cooperation problems.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Cemil Tascioglu City Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to investigate the effects of oxaliplatin-induced peripheral neuropathy on hand function, grip strength, and quality of life in colorectal cancer patients. Assessing the motor symptoms of CIPN and sharing the results in clinical settings will help guide evidence-based practices and interventions.

Read the detailed description

Oxaliplatin is a chemotherapy drug frequently used in the treatment of colorectal cancers, the third most common type of cancer. However, oxaliplatin is associated with long-term neurotoxicity, the most common dose-limiting side effect. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of platinum-based chemotherapy agents, such as oxaliplatin. CIPN limits patients' ability to tolerate treatment and adversely affects long-term quality of life and physical functionality. In individuals undergoing colorectal cancer treatment, the prevalence of CIPN has been reported as 58% at 6 months, 45% at 12 months, 32% at 24 months, and 24% at 36 months post-treatment. Additionally, oxaliplatin exhibits a "coasting phenomenon," in which CIPN symptoms continue to worsen for approximately 3 months after treatment. Although the incidence and sensory symptoms of oxaliplatin-induced CIPN during chemotherapy have been well documented, the chronic-phase motor symptom burden of oxaliplatin-induced CIPN has not been reported. Studies investigating the motor aspects of CIPN are insufficient, and further research is needed to determine its prevalence, progression, and impact on functional outcomes.

Being tested
observational only
Keywords
Colorectal Cancer, Oxaliplatin, Chemotherapy-Induced Peripheral Neuropathy, Hand Function
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • observational onlyOther

    observational only

What is being measured

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

  1. Hand Grip Strength Assessment

    Participants' hand grip strength will be evaluated using the Saehan Hydraulic Hand Dynamometer (SAEHAN Corporation, Yangdeok-Dong, Masan, South Korea) to assess the functional status of the upper extremity and clinical outcomes.

    Measured: baseline only

  2. Finger Grip Strengths (Tip, Key, and Palmar Grip)

    A hydraulic pinch gauge will be used to measure finger grip strengths.

    Measured: baseline only

  3. Hand Function Assessment (Duruöz Hand Index)

    Hand function related to daily activities will be assessed using the Duruöz Hand Index questionnaire. This questionnaire consists of 18 items covering five domains: kitchen tasks, dressing, personal hygiene, work activities, and other activities. Each item is scored on a scale from 0 to 5.

    Measured: baseline

  4. Hand Function Assessment (Michigan Hand Outcomes Questionnaire)

    Overall hand function, including parameters such as pain, aesthetic perception, and patient satisfaction, will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The MHQ was developed in 1998 by hand surgeon Chung and colleagues Pillsbury, Walters, Hayward, and Arbor. The questionnaire consists of six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, and patient-reported hand function. Scores range from 0 to 100. Responses are rated on a scale of 1 to 5 and then normalized to obtain scores for each subdomain.

    Measured: baseline

  5. Fine Motor Skill Assessment (Minnesota Manual Dexterity Test)

    Fine motor skills will be assessed using the Minnesota Manual Dexterity Test (MMDT), which evaluates unilateral and bilateral manual performance of the upper extremities through placement and turning tasks. In the placement test, participants are required to place 60 cylinders one by one into holes on a board as quickly as possible using one hand. The dominant and non-dominant hands are evaluated separately. In the turning test, at the start of the test, all 60 cylinders are placed in the holes. Participants are asked to pick up each cylinder with one hand, rotate it, and return it to the hole using the other hand, repeating this process for all 60 cylinders individually.

    Measured: baseline

  6. Nine-Hole Peg Test (NHPT)

    The Nine-Hole Peg Test is a standardized, well-established, and reliable tool for assessing hand function.

    Measured: Baseline

Secondary outcomes (2)

  1. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Developed in 1987, the EORTC QLQ-C30 is the most widely used quality of life questionnaire in cancer research and clinical practice. It consists of three subdimensions: overall well-being, functional performance, and symptoms. The questionnaire includes five functional scales (physical, social, role, emotional, and cognitive functioning), nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, sleep disturbances, appetite loss, diarrhea, constipation, and financial difficulties), and a global health status scale, totaling 30 items.

    Measured: baseline

  2. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20)

    The EORTC QLQ-CIPN20 is a 20-item quality of life questionnaire designed to assess symptoms and impairments related to sensory, motor, and autonomic neuropathy. It has been widely used in oncology studies. Each item is rated on a 4-point scale, and the questionnaire has been validated for clinical and research use.

    Measured: baseline

Timeline

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

  1. First posted2 Oct 2025
  2. Study start24 Apr 2025
  3. Primary completion20 Jan 2026
  4. Study completion27 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07203066
Sponsor's protocol ID
TY-2025-2260
Status last verified
May 2026
First submitted
24 Sep 2025
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kannarkat G, Lasher EE, Schiff D. Neurologic complications of chemotherapy agents. Curr Opin Neurol. 2007 Dec;20(6):719-25. doi: 10.1097/WCO.0b013e3282f1a06e.

    PubMed 17992096

  • Wild CP, Weiderpass E, Stewart BW, editors. World Cancer Report: Cancer research for cancer prevention. Lyon (FR): International Agency for Research on Cancer; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK606505/

    PubMed 39432694

  • Koseoglu O, Dincer S, Gurdal N, Celik E, Feyzioglu O. Impact of neuropathy severity on hand function, strength, and dexterity in patients with oxaliplatin-induced peripheral neuropathy. BMC Cancer. 2026 Jul 30;26(1):1317. doi: 10.1186/s12885-026-16621-y.

    PubMed 42958115

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Neuropathy Due to Chemotherapy and Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, run by Fenerbahce University 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 5 inclusion and 2 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 1 Jun 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 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?

Hand Grip Strength Assessment (time frame: baseline only). The study lists 6 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 NCT07203066, which also lists 3 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 1 Jun 2026.

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