Cancer PatientsNCT07556965
Exercise and Mindfulness Intervention for Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
A study testing Exercise and Mindfulness in people with Cancer Patients and Chemotherapy-Induced Peripheral Neuropathy, run by Nanjing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Patients, Chemotherapy-Induced Peripheral Neuropathy, Exercise Intervention
- What is being tested?
- Exercise and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jul 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Guangzhou Road Campus
Nanjing, Jiangsu, 210029
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Longjiang Campus
Nanjing, Jiangsu, 210036
About this study
Official title: Effect of an Exercise- and Mindfulness-Based Cognitive Therapy Intervention on Physical and Psychological Symptoms in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
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?
Read more
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
- Being tested
- Exercise and Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine nursing. | Experimental | 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. Receives: Behavioral: Exercise and Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Baseline, 6 weeks and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start17 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingchun Geng, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556965
- Sponsor's protocol ID
- 〔2025〕126
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Exercise- and Mindfulness-Based Cognitive Therapy Intervention on Physical and Psychological Symptoms in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07556965
- Acronym / sponsor ID
- 〔2025〕126
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine nursing. | Experimental | Behavioral: Exercise and MindfulnessThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and MindfulnessParticipants 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. | Behavioural | Routine nursing. |
Primary outcome
Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.
Time frame: Baseline, 6 weeks and 3 months.
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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Mindfulness in people with Cancer Patients and Chemotherapy-Induced Peripheral Neuropathy, run by Nanjing Medical University at 2 sites in China.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy. (time frame: Baseline, 6 weeks and 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.