Neuropathy;PeripheralPhase 2NCT03858153
Exercise and Nutrition Interventions During Chemotherapy K07
A Phase 2 study testing EXCAP Exercise and Nutrition Education in people with Neuropathy;Peripheral, run by University of Rochester at 2 sites in United States.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- EXCAP Exercise and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2019to 27 Aug 2025
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be female
- Have breast cancer
- Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
- Have at least six months life expectancy according to the patient's oncologist or designee
- Be able to read English
- Be at least 18 years old (no upper limit on age)
- Provide written informed consent
Who cannot join
- Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
- Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
- Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)
- 1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
- Conditions
- Neuropathy;Peripheral
- Being tested
- EXCAP Exercise, Nutrition Education
- Keywords
- chemotherapy
- Medical subject headings
- Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCAP ExerciseBehavioural
12 weeks of at-home walking and resistance exercise.
Nutrition EducationBehavioural
12 weeks of implementing eating tips and tracking food.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. Receives: Behavioral: EXCAP Exercise |
| Nutrition Education | Active comparator | Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription. Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Measured: Time point 2 (approximately 6 weeks), controlling for baseline value
Secondary outcomes (4)
Sensory loss
Finger tactile sensitivity
Measured: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Numbness and tingling
Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Measured: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Sensory, motor, and autonomic symptoms of CIPN
CIPN-20 total score (Postma et al 2005). The score includes 20 questions, each rated 1-4, and the score ranges from 20-80 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Measured: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Patient-reported sensory symptoms of CIPN
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Measured: Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start15 Apr 2019
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathy;PeripheralStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Po-Ju Lin, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858153
- Sponsor's protocol ID
- STUDY00003387
- Other IDs
- K07CA221931
- Status last verified
- Dec 2025
- First submitted
- 15 Feb 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interested researchers may contact the study PI with requests for collaboration.
Publications
Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
PubMed 15911236
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
- ClinicalTrials.gov ID
- NCT03858153
- Acronym / sponsor ID
- STUDY00003387
- Conditions
- Neuropathy;Peripheral
- Keywords
- chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 28 Feb 2019 (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 highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: EXCAP ExerciseExercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. |
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationNutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be female
- Have breast cancer
- Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
- Have at least six months life expectancy according to the patient's oncologist or designee
- Be able to read English
Key exclusion criteria (4 listed)
- Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
- Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
- Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)
- 1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
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 |
|---|---|---|
| EXCAP Exercise12 weeks of at-home walking and resistance exercise. | Behavioural | Exercise |
| Nutrition Education12 weeks of implementing eating tips and tracking food. | Behavioural | Nutrition Education |
Primary outcome
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
Time frame: Time point 2 (approximately 6 weeks), controlling for baseline value
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
4 secondary outcomes
Sensory loss
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Numbness and tingling
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Sensory, motor, and autonomic symptoms of CIPN
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Patient-reported sensory symptoms of CIPN
Time frame: Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline
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 22 Dec 2025.
- Background: PubMed 15911236Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
- Individual participant dataSharing planned: Yes. Interested researchers may contact the study PI with requests for collaboration.
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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 Phase 2 study testing EXCAP Exercise and Nutrition Education in people with Neuropathy;Peripheral, run by University of Rochester at 2 sites in United States.
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 7 inclusion and 4 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 22 Dec 2025. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN) (time frame: Time point 2 (approximately 6 weeks), controlling for baseline value). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858153, which also lists 1 linked publication.
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 22 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.