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Exercise and Nutrition Interventions During Chemotherapy K07

Primary Purpose

Neuropathy;Peripheral

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EXCAP Exercise
Nutrition Education
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathy;Peripheral focused on measuring chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria (subjects must…)

  1. Be female
  2. Have breast cancer
  3. Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
  4. Have at least six months life expectancy according to the patient's oncologist or designee
  5. Be able to read English
  6. Be at least 18 years old (no upper limit on age)
  7. Provide written informed consent

Exclusion criteria (subjects must not…)

  1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
  2. 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)

Sites / Locations

  • University of MarylandRecruiting
  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Nutrition Education

Arm Description

Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.

Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sensory loss
Finger tactile sensitivity
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).
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).
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).

Full Information

First Posted
February 15, 2019
Last Updated
August 10, 2023
Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03858153
Brief Title
Exercise and Nutrition Interventions During Chemotherapy K07
Official Title
The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy;Peripheral
Keywords
chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessor and investigator will be masked of Arms to the extent possible (i.e., for some outcomes e.g., biomarkers but not others e.g. symptom tests).
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
Intervention Type
Behavioral
Intervention Name(s)
EXCAP Exercise
Intervention Description
12 weeks of at-home walking and resistance exercise.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
12 weeks of implementing eating tips and tracking food.
Primary Outcome Measure Information:
Title
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
Description
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).
Time Frame
Time point 2 (approximately 6 weeks), controlling for baseline value
Secondary Outcome Measure Information:
Title
Sensory loss
Description
Finger tactile sensitivity
Time Frame
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Title
Numbness and tingling
Description
Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time Frame
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Title
Sensory, motor, and autonomic symptoms of CIPN
Description
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).
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
Title
Patient-reported sensory symptoms of CIPN
Description
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).
Time Frame
Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline
Other Pre-specified Outcome Measures:
Title
Musculoskeletal function
Description
Leg strength via isokinetic dynamometer test
Time Frame
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Title
Cardiovascular function
Description
Distance walked in six-minute walk test
Time Frame
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Title
Neuropsychological function
Description
Brain connectivity via functional magnetic resonance imaging
Time Frame
Time point 2 (approx. 6 weeks), controlling for baseline
Title
Immunological function
Description
Inflammatory cytokine concentration via ELISA (IL-6, IL-10, etc.)
Time Frame
Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (subjects must…) 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 Exclusion criteria (subjects must not…) 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Kleckner, PhD, MPH
Phone
410-706-5981
Email
ian.kleckner@umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Ju Lin, PhD, RD, MPH
Phone
585-276-6001
Email
po-ju_lin@URMC.Rochester.edu
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Kleckner, PhD, MPH
Phone
410-706-5981
Email
ian.kleckner@umaryland.edu
First Name & Middle Initial & Last Name & Degree
Amelia Wagenknecht, BS
Phone
410-706-6298
Email
awagenknecht@umaryland.edu
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Interested researchers may contact the study PI with requests for collaboration.
Citations:
PubMed Identifier
15911236
Citation
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.
Results Reference
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Exercise and Nutrition Interventions During Chemotherapy K07

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