NCT07321236

Brief Summary

The goal of this clinical trial is to determine whether hand and foot exercises can reduce the severity of Taxane-based chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients aged 20-60 years who have Grade 1I neuropathy as defined by the NCI-CTCAE criteria. The main questions it aims to answer are:

  • Do hand and foot exercises reduce the severity of sensory and motor neuropathic symptoms in patients receiving Taxane based chemotherapy?
  • Is the severity of peripheral neuropathy lower in the exercise group compared to patients receiving standard care alone? Researchers will compare patients receiving standard care (control group) with those receiving standard care plus a structured hand and foot exercise program (experimental group) to see if the exercises lead to greater improvement in neuropathy severity scores. Participants will:
  • Receive baseline assessment using the EORTC QLQ-CIPN20 questionnaire.
  • In the experimental group, learn and perform a 15-minute hand and foot exercise routine on chemotherapy day and continue it at home using a provided brochure.
  • Participate in telephonic follow-ups to support compliance and monitor symptoms.
  • Undergo a follow-up assessment at alternate week to measure changes in neuropathy severity.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 21, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

Peripheral neuropathyTaxaneChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Severity of peripheral neuropathy

    The primary outcome of this study is the severity of chemotherapy-induced peripheral neuropathy in cancer patients receiving Taxane-based chemotherapy. Severity will be measured using the EORTC QLQ-CIPN20 questionnaire, which assesses sensory symptoms (tingling, numbness, burning), motor symptoms (difficulty gripping or walking), and autonomic symptoms (such as dizziness). Each item is scored from 1 (not at all) to 4 (very much), with higher scores indicating more severe neuropathy. Assessments will be conducted at baseline (week 1) and week 8 to determine whether the hand and foot exercise program reduces symptom severity compared to standard care alone.

    6 Months

Study Arms (2)

Standard Care (Control)

NO INTERVENTION

Standard care

Hand and Foot Exercise Program + Standard Care (Experimental)

EXPERIMENTAL

Structured Hand and Foot Exercises and standard care

Other: Structured Hand and Foot Exercises

Interventions

The intervention consists of a structured hand and foot exercise program specifically designed for patients experiencing chemotherapy-induced peripheral neuropathy during Taxane-based treatment. It is distinct from general physiotherapy or mobility exercises because it targets peripheral nerve function, joint mobility, and circulation in the hands and feet, aiming to reduce the severity of neuropathic symptoms.

Hand and Foot Exercise Program + Standard Care (Experimental)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cancer patients receiving taxane-based chemotherapy on alternate week.
  • Age 20-60 years, both male and female.
  • Patients having Grade I neuropathy by NCI-CTCEA criteria.

You may not qualify if:

  • Patients with peripheral neuropathy not caused by chemotherapy.
  • Patient with type-1 and type- 2 diabetes.
  • Patients with neuropsychiatric disorders.
  • Patients having any skin ulcer.
  • Individuals having hand foot fracture and varicose veins.
  • Individuals with paraplegia.
  • Patients receiving radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yeo F, Ng CC, Loh KWJ, Molassiotis A, Cheng HL, Au JSK, Leung KT, Li YC, Wong KH, Suen L, Chan CW, Yorke J, Farrell C, Bandla A, Ang E, Lopez V, Sundar R, Chan A. Minimal clinically important difference of the EORTC QLQ-CIPN20 for worsening peripheral neuropathy in patients receiving neurotoxic chemotherapy. Support Care Cancer. 2019 Dec;27(12):4753-4762. doi: 10.1007/s00520-019-04771-8. Epub 2019 Apr 10.

    PMID: 30972646BACKGROUND

Related Links

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

  • Kausar Bano, MBBS, FCPS

    Jinnah Hospital,Lahore.

    STUDY CHAIR

Central Study Contacts

N Hussain, Generic BSN

CONTACT

D Khan, Generic BSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel arms and will remain in that assigned arm for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (MSN student)

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access