Exercise and Nutrition Interventions During Chemotherapy

NCT03021174 | Completed DMC

• 1 other identifier: RSRB00066046
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuropathy;Peripheral

Keywords

CIPN; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (4)

• Percent of patients screened who are eligible

  Number of patients eligible divided by number of patients screened

  12 weeks

• Percent of patients eligible who are consented

  Number of patients consented divided by number of patients approached

  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

  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)

  12 weeks

Study Arms (2)

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.

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.

Behavioral: Nutrition Education Control

Interventions

EXCAP Exercise BEHAVIORAL

12 weeks of at-home walking and resistance exercise

Exercise

Nutrition Education Control BEHAVIORAL

12 weeks of implementing eating tips

Nutrition Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 39304604 DERIVED

• 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. Res Sq [Preprint]. 2024 Mar 13:rs.3.rs-4022351. doi: 10.21203/rs.3.rs-4022351/v1.

  PMID: 38559210 DERIVED

MeSH Terms

Conditions

Neuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: June 28, 2017
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)