Neuropathy;PeripheralNCT03021174
Exercise and Nutrition Interventions During Chemotherapy
A study testing EXCAP Exercise in people with Neuropathy;Peripheral, run by University of Rochester at 1 site in United States.
Trial summary
This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- EXCAP Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 11 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have non-metastatic cancer
- Be chemotherapy naïve
- Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention (12 weeks)
- Report symptoms of peripheral neuropathy at baseline (subject-reported severity of numbness and tingling in hands/feet of at least 1 on a 0-10 scale)
- Be able to perform the exercise intervention
- Be able to read English
Show all 9Show fewer
- Be at least 18 years old (no upper limit on age)
- Be consistently right-handed in daily activities for consistency in reporting any lateralized effects from brain imaging
- Provide written informed consent
Who cannot join
- Receive surgery, radiation, or hormone therapy for their cancer during the study
- Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
- Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. - note that most port-a-caths are safe for MRI scanning)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).
Read the detailed description
This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.
- Conditions
- Neuropathy;Peripheral
- Being tested
- EXCAP Exercise, Nutrition Education Control
- Keywords
- CIPN, Chemotherapy-induced peripheral neuropathy
- 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 Education ControlBehavioural
12 weeks of implementing eating tips
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. Receives: Behavioral: EXCAP Exercise |
| Nutrition Education Control | Active comparator | Nutrition education (control) 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 Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients screened who are eligible
Number of patients eligible divided by number of patients screened
Measured: 12 weeks
Percent of patients eligible who are consented
Number of patients consented divided by number of patients approached
Measured: 12 weeks
Percent of patients consented who complete the exercise intervention
Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm
Measured: 12 weeks
Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy
Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start28 Jun 2017
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Kleckner, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021174
- Sponsor's protocol ID
- RSRB00066046
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested researchers may contact the study PI with requests for collaboration.
Publications
Kleckner IR, Manuweera T, Lin PJ, Chung KH, Kleckner AS, Gewandter JS, Culakova E, Tivarus ME, Dunne RF, Loh KP, Mohile NA, Kesler SR, Mustian KM. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system. Support Care Cancer. 2024 Sep 21;32(10):677. doi: 10.1007/s00520-024-08855-y.
PubMed 39304604Kleckner IR, Manuweera T, Lin PJ, Chung KH, Kleckner AS, Gewandter JS, Culakova E, Tivarus ME, Dunne RF, Loh KP, Mohile NA, Kesler SR, Mustian KM. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system. Res Sq [Preprint]. 2024 Mar 13:rs.3.rs-4022351. doi: 10.21203/rs.3.rs-4022351/v1.
PubMed 38559210
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
- ClinicalTrials.gov ID
- NCT03021174
- Acronym / sponsor ID
- RSRB00066046
- Conditions
- Neuropathy;Peripheral
- Keywords
- CIPN, Chemotherapy-induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- 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.
This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).
Detailed description
This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: EXCAP ExerciseExercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. |
| Nutrition Education Control | Active comparator | Behavioral: Nutrition Education ControlNutrition education (control) 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have non-metastatic cancer
- Be chemotherapy naïve
- Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention (12 weeks)
- Report symptoms of peripheral neuropathy at baseline (subject-reported severity of numbness and tingling in hands/feet of at least 1 on a 0-10 scale)
- Be able to perform the exercise intervention
Key exclusion criteria (4 listed)
- Receive surgery, radiation, or hormone therapy for their cancer during the study
- Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
- Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. - note that most port-a-caths are safe for MRI scanning)
- 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.
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 Education Control12 weeks of implementing eating tips | Behavioural | Nutrition Education Control |
Primary outcome
Percent of patients screened who are eligible
Time frame: 12 weeks
Number of patients eligible divided by number of patients screened
Percent of patients eligible who are consented
Time frame: 12 weeks
Number of patients consented divided by number of patients approached
Percent of patients consented who complete the exercise intervention
Time frame: 12 weeks
Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm
Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy
Time frame: 12 weeks
Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)
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 18 Jul 2019.
- Derived from this study: PubMed 39304604Kleckner IR, Manuweera T, Lin PJ, Chung KH, Kleckner AS, Gewandter JS, Culakova E, Tivarus ME, Dunne RF, Loh KP, Mohile NA, Kesler SR, Mustian KM. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system. Support Care Cancer. 2024 Sep 21;32(10):677. doi: 10.1007/s00520-024-08855-y.
- Derived from this study: PubMed 38559210Kleckner IR, Manuweera T, Lin PJ, Chung KH, Kleckner AS, Gewandter JS, Culakova E, Tivarus ME, Dunne RF, Loh KP, Mohile NA, Kesler SR, Mustian KM. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system. Res Sq [Preprint]. 2024 Mar 13:rs.3.rs-4022351. doi: 10.21203/rs.3.rs-4022351/v1.
- Individual participant dataSharing planned: No. 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXCAP Exercise in people with Neuropathy;Peripheral, run by University of Rochester at 1 site 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 9 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 18 Jul 2019. 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 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.
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?
Percent of patients screened who are eligible (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 NCT03021174, which also lists 2 linked publications.
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 18 Jul 2019.