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Trial · NCT07877558

Home-Based Exercise and Vagus Nerve Stimulation for Chemotherapy-Induced Neuropathy

NCT07877558, Not applicable, Not yet recruiting, The Hong Kong Polytechnic University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Home-Based Exercise and Vagus Nerve Stimulation for Chemotherapy-Induced Neuropathy. Trials, record NCT07877558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877558

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Home-Based Exercise and Vagus Nerve Stimulation for Chemotherapy-Induced Neuropathy
NCT number
NCT07877558
Status
Not yet recruiting
Phases
Not applicable
Enrollment
60 participants, estimated
Lead sponsor
The Hong Kong Polytechnic University
Conditions
Chemotherapy-induced Neuropathy
Interventions
Active non-invasive vagus nerve stimulation (nVNS), Sham non-invasive vagus nerve stimulation (nVNS), Home-based aerobic and resistance exercise program
First posted
2026-10-16
Last updated
2026-10-16

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
Patient-Reported Chemotherapy-Induced Neuropathy as Assessed by the Chinese Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20)
From enrollment to the end of treatment at Week 12.
The Chinese version of the EORTC QLQ-CIPN20 will be utilized to assess patient-reported chemotherapy-induced neuropathy. This 20-item questionnaire is an effective tool recommended by the National Cancer Institute for evaluating the CIPN phenotype, which includes sensory, motor, and autonomic symptoms in clinical trials. Both the Chinese and English versions demonstrate good internal consistency (Cronbach's α = 0.78-0.90), test-retest reliability (r = 0.73-0.84), and responsiveness to change (Cohen's d = 0.42-1.42).
SecondaryClinician-Reported Chemotherapy-Induced Neuropathy as Assessed by the Total Neuropathy Score-Nurse (TNSn)At baseline (before intervention), Week 6, and Week 12 after randomization.
The TNSn will be used. This tool includes three symptom-related questions that evaluate sensory symptom distribution, motor symptom impact, and autonomic symptom presence, along with assessments of vibration and pinprick sensations. Each symptom and sign is rated on a scale from 0 to 4, with higher scores indicating more severe conditions. The TNSn has been validated in clinimetric studies, showing a Minimal Clinically Important Difference of 2.79 points.
SecondaryGeneral Symptoms as Assessed by the Symptom Distress Scale (SDS)At baseline (before intervention), Week 6, and Week 12 after randomization.
The SDS will be used to assess general symptoms, including nausea, loss of appetite, insomnia, pain, fatigue, constipation and diarrhea, concentration difficulties, and changes in physical appearance. The scale employs a 5-point Likert-type scoring system, where 1 indicates normal symptom levels and 5 represents the highest degree of distress. Total scores range from 10 to 50, with higher scores reflecting greater symptom distress. Previous studies have shown that the SDS has acceptable internal consistency, with Cronbach's α values between 0.71 and 0.88.
SecondaryTimed Up and Go TestAt baseline (before intervention), Week 6, and Week 12 after randomization.
The TUGT measures dynamic balance and mobility by timing how long it takes a participant to rise from a seated position, walk three meters, turn around, walk back, and sit down. Participants will perform the task twice, and the average time will be recorded.
Secondary6-Minute Walk TestAt baseline (before intervention), Week 6, and Week 12 after randomization.
The 6MWT evaluates endurance and physical performance by measuring the distance participants can walk at their usual speed for six minutes along a flat corridor, with the total distance recorded in meters. This test quantitatively reflects functional performance and exercise capacity, making it relevant for this population.
SecondaryHealth-Related Quality of Life as Assessed by the Chinese Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)At baseline (before intervention), Week 6, and Week 12 after randomization.
The EORTC QLQ-C30 will be used to assess health-related quality of life. Previous studies indicate moderate to good test-retest reliability (r = 0.54-0.86) and person separation reliability (r = 0.47-0.89) for both the English and Chinese versions.
OtherRecruitment rateThrough study completion, an average of 2 years.Defined as the number of eligible participants who provide informed consent and are randomized, divided by the total number of eligible patients identified, multiplied by 100.
OtherRetention rateThrough study completion, an average of 2 years.Defined as the percentage of enrolled patients who complete both the baseline and all follow-up assessments.
OtherAcceptability as Assessed by the Chinese version of the Patients' Global Impression of ChangeAt Week 12 (post-intervention)
The Chinese version of the PGIC is a single-item, 7-point numerical rating scale ranging from 1 to 7 that assesses participants' subjective perceptions of improvement and satisfaction after receiving the study intervention.
OtherAdherence to aerobic exerciseDaily during the 12-week intervention period, from randomization through Week 12.Adherence to the prescribed aerobic exercise, measured by the number of steps taken per day.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers38

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
14739871BACKGROUNDPubMed
23051872BACKGROUNDPubMed
23195919BACKGROUNDPubMed
23947980BACKGROUNDPubMed
26252436BACKGROUNDPubMed
27033012BACKGROUNDPubMed
29243164BACKGROUNDPubMed
29580658BACKGROUNDPubMed
29873180BACKGROUNDPubMed
30217648BACKGROUNDPubMed

1 to 10 of 38

See all 38 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07877558

GET https://conductscience.org/api/trials/v1/NCT07877558/papers?page=2