NeuropathyNCT07635901
Exercise Intervention for Chemotherapy-Induced Peripheral Neuropathy
A study testing Structured exercise program for CIPN in people with Neuropathy and Oncology, run by Sri Ramachandra Institute of Higher Education and Research at 1 site in India.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that can negatively impact patients' functional status and quality of life. This study was conducted in two phases among oncology patients receiving chemotherapy at a tertiary care teaching hospital in Chennai, India. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Neuropathy, Oncology, Exercise
- What is being tested?
- Structured exercise program for CIPN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Receiving chemotherapy
- Diagnosed with mild or moderate chemotherapy-induced peripheral neuropathy
- Willing to participate and provide informed consent
Who cannot join
- Pre-existing peripheral neuropathy unrelated to chemotherapy (e.g., diabetic neuropathy).
- Uncontrolled diabetes mellitus.
- Significant cardiovascular disease.
- Severe musculoskeletal disorders.
- Contraindications to exercise, including recent surgery, bone metastases, or severe anemia.
- Severe mobility limitations.
- Severe mental health conditions affecting participation.
Trial locations and contacts
1 site in 1 country.
India1 site
Sri Ramachandra Institute of Higher Education and Research
Chennai, Tamil Nadu, 600116
About this study
Official title: Prevalence and Effectiveness of Exercise on Chemotherapy-induced Peripheral Neuropathy Among Oncology Patients
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that can negatively impact patients' functional status and quality of life. This study was conducted in two phases among oncology patients receiving chemotherapy at a tertiary care teaching hospital in Chennai, India. Phase I used a descriptive survey design to determine the prevalence of CIPN. Phase II employed a randomized controlled experimental design to evaluate the effectiveness of a structured exercise program in reducing CIPN symptoms among patients with mild to moderate CIPN. Eligible participants were randomly assigned to intervention and control groups. The intervention group received education and supervised exercises involving lower and upper extremity movements, while the control group received routine care. Outcomes were assessed using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale before and after a 21-day intervention period.
Read the detailed description
This quantitative study was conducted in two phases. Phase I assessed the prevalence of chemotherapy-induced peripheral neuropathy among oncology patients receiving chemotherapy. A total of 282 participants were enrolled.
Based on the prevalence findings, Phase II was conducted to determine the effectiveness of a structured exercise program. One hundred and twenty patients with mild or moderate CIPN were randomly allocated into intervention (n=60) and control (n=60) groups using a lottery method. The intervention consisted of education regarding CIPN and a structured exercise program including toe flexion and extension, ankle circles, toe spreading, heel raises, finger extension stretches, pinch grips, and finger circles. Exercises were performed 10-15 repetitions per extremity, 2-3 times daily, for 21 days.
Participants in the control group received routine oncology care. CIPN severity was measured before and after the intervention using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale. Statistical analyses included descriptive statistics, paired t-tests, independent t-tests, and chi-square tests.
- Conditions
- Neuropathy, Oncology, Exercise, Effectiveness, Patients on Chemotherapy
- Being tested
- Structured exercise program for CIPN
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Exercise Therapy, Oncology Patients, Randomized Controlled Trial
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise program for CIPNBehavioural
Patients in the intervention group receive structured education about CIPN, which included its definition, risk factors, signs and symptoms, and management through exercises. The exercises were demonstrated by the researcher and involved leg toe flexion and extension, ankle circles, toe spreading, heel raises, as well as hand exercises such as finger extension stretches, pinch grips, and finger circles. Participants were asked to return demonstrate the exercises, continue practicing them under supervision for one to two days during hospitalization for chemotherapy and after discharge for a period of 21 days when they came for their subsequent cycle of chemotherapy. This was then reinforced using a pamphlet which was provided to the patients, and patients were encouraged to maintain a daily practice
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Structured Exercise Program | Experimental | Participants received structured education regarding chemotherapy-induced peripheral neuropathy and performed a supervised exercise program involving lower and upper extremity exercises for 21 days in addition to routine care. Receives: Behavioral: Structured exercise program for CIPN |
| Control Arm: Routine Care | No intervention | Participants received standard oncology care including consultation and medication management according to institutional protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Chemotherapy-Induced Peripheral Neuropathy
Change in CIPN severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
Measured: Baseline and Day 21
Secondary outcomes (1)
Prevalence of Chemotherapy-Induced Peripheral Neuropathy among oncology patients receiving chemotherapy.
Prescence of CIPN and its severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
Measured: At baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Oct 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study employed a randomized, parallel-assignment intervention model with an open-label design, and its primary purpose was treatment. Phase I consisted of a prevalence survey involving 282 oncology patients to determine the prevalence of chemotherapy-induced peripheral neuropathy (CIPN). Phase II included 120 patients with mild to moderate CIPN who were randomly assigned to either the study group or the control group to evaluate the effectiveness of an exercise intervention on CIPN symptoms.
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Ramachandra Institute of Higher Education and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seethalakshmi Avudaiappan, Sri Ramachandra Institute of Higher Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635901
- Sponsor's protocol ID
- 05/185
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. De-identified data may be available from the corresponding investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Effectiveness of Exercise on Chemotherapy-induced Peripheral Neuropathy Among Oncology Patients
- ClinicalTrials.gov ID
- NCT07635901
- Acronym / sponsor ID
- 05/185
- Conditions
- Neuropathy, Oncology, Exercise, Effectiveness, Patients on Chemotherapy
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Exercise Therapy, Oncology Patients, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Sri Ramachandra Institute of Higher Education and ResearchUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Jun 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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that can negatively impact patients' functional status and quality of life. This study was conducted in two phases among oncology patients receiving chemotherapy at a tertiary care teaching hospital in Chennai, India. Phase I used a descriptive survey design to determine the prevalence of CIPN. Phase II employed a randomized controlled experimental design to evaluate the effectiveness of a structured exercise program in reducing CIPN symptoms among patients with mild to moderate CIPN. Eligible participants were randomly assigned to intervention and control groups. The intervention group received education and supervised exercises involving lower and upper extremity movements, while the control group received routine care. Outcomes were assessed using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale before and after a 21-day intervention period.
Detailed description
This quantitative study was conducted in two phases. Phase I assessed the prevalence of chemotherapy-induced peripheral neuropathy among oncology patients receiving chemotherapy. A total of 282 participants were enrolled.
Based on the prevalence findings, Phase II was conducted to determine the effectiveness of a structured exercise program. One hundred and twenty patients with mild or moderate CIPN were randomly allocated into intervention (n=60) and control (n=60) groups using a lottery method. The intervention consisted of education regarding CIPN and a structured exercise program including toe flexion and extension, ankle circles, toe spreading, heel raises, finger extension stretches, pinch grips, and finger circles. Exercises were performed 10-15 repetitions per extremity, 2-3 times daily, for 21 days.
Participants in the control group received routine oncology care. CIPN severity was measured before and after the intervention using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale. Statistical analyses included descriptive statistics, paired t-tests, independent t-tests, and chi-square tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study employed a randomized, parallel-assignment intervention model with an open-label design, and its primary purpose was treatment. Phase I consisted of a prevalence survey involving 282 oncology patients to determine the prevalence of chemotherapy-induced peripheral neuropathy (CIPN). Phase II included 120 patients with mild to moderate CIPN who were randomly assigned to either the study group or the control group to evaluate the effectiveness of an exercise intervention on CIPN symptoms.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Structured Exercise Program | Experimental | Behavioral: Structured exercise program for CIPNParticipants received structured education regarding chemotherapy-induced peripheral neuropathy and performed a supervised exercise program involving lower and upper extremity exercises for 21 days in addition to routine care. |
| Control Arm: Routine Care | No intervention | –Participants received standard oncology care including consultation and medication management according to institutional protocols. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Receiving chemotherapy
- Diagnosed with mild or moderate chemotherapy-induced peripheral neuropathy
- Willing to participate and provide informed consent
Key exclusion criteria (7 listed)
- Pre-existing peripheral neuropathy unrelated to chemotherapy (e.g., diabetic neuropathy).
- Uncontrolled diabetes mellitus.
- Significant cardiovascular disease.
- Severe musculoskeletal disorders.
- Contraindications to exercise, including recent surgery, bone metastases, or severe anemia.
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 |
|---|---|---|
| Structured exercise program for CIPNPatients in the intervention group receive structured education about CIPN, which included its definition, risk factors, signs and symptoms, and management through exercises. The exercises were demonstrated by the researcher and involved leg toe flexion and extension, ankle circles, toe spreading, heel raises, as well as hand exercises such as finger extension stretches, pinch grips, and finger circles. Participants were asked to return demonstrate the exercises, continue practicing them under supervision for one to two days during hospitalization for chemotherapy and after discharge for a period of 21 days when they came for their subsequent cycle of chemotherapy. This was then reinforced using a pamphlet which was provided to the patients, and patients were encouraged to maintain a daily practice | Behavioural | Experimental Arm: Structured Exercise Program |
Primary outcome
Severity of Chemotherapy-Induced Peripheral Neuropathy
Time frame: Baseline and Day 21
Change in CIPN severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
1 secondary outcome
Prevalence of Chemotherapy-Induced Peripheral Neuropathy among oncology patients receiving chemotherapy.
Time frame: At baseline assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. De-identified data may be available from the corresponding investigator upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise program for CIPN in people with Neuropathy and Oncology, run by Sri Ramachandra Institute of Higher Education and Research at 1 site in India.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Chemotherapy-Induced Peripheral Neuropathy (time frame: Baseline and Day 21). 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 9 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.