NCT07203066

Brief 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. Assessing the motor symptoms of CIPN and sharing the results in clinical settings will help guide evidence-based practices and interventions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 24, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

Colorectal CancerOxaliplatinChemotherapy-Induced Peripheral NeuropathyHand Function

Outcome Measures

Primary Outcomes (6)

  • 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.

    baseline only

  • Finger Grip Strengths (Tip, Key, and Palmar Grip)

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

    baseline only

  • 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.

    baseline

  • 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.

    baseline

  • 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.

    baseline

  • Nine-Hole Peg Test (NHPT)

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

    Baseline

Secondary Outcomes (2)

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

    baseline

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

    baseline

Interventions

observational only

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

colorectal cancer patients who received oxaliplatin based chemotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 17992096BACKGROUND
  • 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/

    PMID: 39432694BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Ozge Koseoglu, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assisstant

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

September 24, 2025

Primary Completion

December 24, 2025

Study Completion

February 24, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share