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Active, not recruitingNCT07556965Updated Sep 29, 2026

Exercise and Mindfulness Intervention for Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

An interventional study of Exercise and Mindfulness in Cancer Patients, Chemotherapy-Induced Peripheral Neuropathy and Exercise Intervention, sponsored by Nanjing Medical University. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Supportive care

Updated Sep 29, 2026Now Active, not recruitingFirst site in China+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn whether an exercise- and mindfulness-based cognitive therapy intervention can improve physical and psychological symptoms in cancer patients with chemotherapy-induced peripheral neuropathy. It will also examine whether this intervention can improve quality of life. The main questions it aims to answer are:

Can this intervention reduce physical symptoms related to chemotherapy-induced peripheral neuropathy? Can this intervention reduce psychological symptoms in affected patients? Can this intervention improve patients' quality of life?

Participants will:

Follow a structured program of regular exercise and mindfulness practice Undergo weekly assessments of symptom changes Keep records of their symptom changes during the intervention period

02

Conditions studied

  • Cancer Patients
  • Chemotherapy-Induced Peripheral Neuropathy
  • Exercise Intervention
03

In context

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with a pathologically confirmed malignant tumor;
  • Currently receiving neurotoxic chemotherapy and experiencing chemotherapy-induced peripheral neuropathy (CIPN);
  • Cancer stage Tis or stage I-III;
  • Aged 18 years or older, with normal consciousness, mental status, and verbal communication ability; able to understand and judge their own sensations and general condition; and able to complete the questionnaires;
  • Willing to participate in the study and able to provide written informed consent;
  • Patients with NCI-CTCAE grade \<2 who are considered suitable for exercise intervention.

Exclusion criteria

Exclusion Criteria:

  • Presence of other neurological diseases or severe psychiatric disorders;
  • Presence of other serious illnesses, such as severe heart disease or respiratory failure;
  • Inability to understand or complete the questionnaires;
  • Participation in psychological counseling, psychotherapy, or other clinical trials within the past 6 months;
  • Inability or expected inability to complete the full 6-week intervention.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Routine nursing.

    The intervention group will receive an exercise- and mindfulness-based cognitive therapy program. Exercise training will include aerobic exercise and resistance training, conducted 3-5 times per week for 20-30 minutes per session. Mindfulness practice will include mindfulness breathing, body scan, and mindful walking, conducted daily for 10-15 minutes per session.

    Behavioral: Exercise and Mindfulness

Interventions

  • BehavioralExercise and Mindfulness

    Participants in the intervention group will receive a structured exercise- and mindfulness-based cognitive therapy program. This combined behavioral intervention includes two integrated components: (1) exercise training, consisting of aerobic exercise and resistance training, performed 3-5 times per week for 20-30 minutes per session; and (2) mindfulness practice, consisting of mindfulness breathing, body scan, and mindful walking, performed daily for 10-15 minutes per session. Unlike routine care or single-component interventions, this program combines physical exercise with mindfulness practice to target both physical and psychological symptoms associated with chemotherapy-induced peripheral neuropathy. Weekly symptom assessments and symptom change records will be completed during the intervention period.

06

What researchers measure

Primary outcomes

  1. Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.

    The degree of change from baseline after the intervention (using the Treatment-Induced Neuropathy Assessment Scale (TNAS) to assess patients' CIPN-related physical symptom burden. The scale consists of 9 items, each scored from 0 to 10, with higher scores indicating a greater symptom burden. The Kessler Psychological Distress Scale (K10) was used to assess the level of psychological distress. The scale consists of 10 items, rated on a 5-point scale, with higher total scores indicating more severe psychological distress.)

    Time frame: Baseline, 6 weeks and 3 months.

07

Study locations

2 sites
  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Guangzhou Road Campus
    Nanjing, Jiangsu 210029, China
  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Longjiang Campus
    Nanjing, Jiangsu 210036, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Active, not recruiting
changed Sep 29, 2026
Sites
2 sites added — first site in China
Show 2 added (2 China)
  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Guangzhou Road Campus · Nanjing, China
  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Longjiang Campus · Nanjing, China
Sep 29, 2026
Start date
Apr 20, 2026→Jul 17, 2026 (actual)
Sep 29, 2026
Primary completion
Sep 30, 2026→Nov 30, 2026
Sep 29, 2026
Study completion
Jun 30, 2027→Nov 30, 2027
Sep 29, 2026
Enrollment
40 (estimated)→41 (actual)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Not yet recruiting→Active, not recruiting
    2 sites added — first site in China
    Show 2 added (2 China)
    • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Guangzhou Road Campus · Nanjing, China
    • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Longjiang Campus · Nanjing, China
    Start date Apr 20, 2026→Jul 17, 2026 (now actual)
    Primary completion Sep 30, 2026→Nov 30, 2026
    Study completion Jun 30, 2027→Nov 30, 2027
    Enrollment 40 (estimated)→41 (actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07556965
Lead sponsor
Nanjing Medical University
Responsible party
Qingchun Geng (Student, Nanjing Medical University) — Principal investigator
First posted
Apr 29, 2026
Start date
Jul 17, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Sep 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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