Exercise and Nutrition Interventions During Chemotherapy

Neuropathy;Peripheral Clinical Trial

Official title:

A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021174
• Other study ID #: RSRB00066046
• Status: Completed
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: October 11, 2018

Study information

• Verified date: July 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• EXCAP Exercise
12 weeks of at-home walking and resistance exercise
• Nutrition Education Control
12 weeks of implementing eating tips

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients screened who are eligible	Number of patients eligible divided by number of patients screened	12 weeks
Primary	Percent of patients eligible who are consented	Number of patients consented divided by number of patients approached	12 weeks
Primary	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	12 weeks
Primary	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)	12 weeks