Exercise and Nutrition Interventions During Chemotherapy

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT03021174
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Neuropathy;Peripheral	Behavioral: EXCAP Exercise; Behavioral: Nutrition Education Control	N/A

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

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
• Actual Study Start Date: Jun 28, 2017
• Actual Primary Completion Date: Oct 11, 2018
• Actual Study Completion Date: Oct 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise 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.	Behavioral: EXCAP Exercise; 12 weeks of at-home walking and resistance exercise
Active Comparator: Nutrition Education Control 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.	Behavioral: Nutrition Education Control; 12 weeks of implementing eating tips

Outcome Measures

Primary Outcome Measures

1. Percent of patients screened who are eligible [12 weeks]

   Number of patients eligible divided by number of patients screened

2. Percent of patients eligible who are consented [12 weeks]

   Number of patients consented divided by number of patients approached

3. Percent of patients consented who complete the exercise intervention [12 weeks]

   Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm

4. Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy [12 weeks]

   Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ian Kleckner, Research Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03021174
• Other Study ID Numbers: RSRB00066046
• First Posted: Jan 13, 2017
• Last Update Posted: Jul 18, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ian Kleckner, Research Assistant Professor, University of Rochester: CIPN; Chemotherapy-induced peripheral neuropathy
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

No Results Posted as of Jul 18, 2019