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Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

EXCAP Exercise

Nutrition Education

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Chemotherapy, Brain, Exercise, Nutrition

Eligibility Criteria

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

Inclusion criteria (subjects must…)

Have a diagnosis of gastrointestinal cancer
Be scheduled to receive platinum chemotherapy (specifically oxaliplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide)
Be able to read English
Be ≥18 years

Exclusion criteria (subjects must not…)

Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
Apparent 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)
Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat.
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.
Be pregnant or become pregnant in the next 8 weeks (for MRI safety)
Have planned surgery or radiation treatment in the 12 weeks after baseline.

Sites / Locations

University of Maryland Medical SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EXCAP 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

CIPN-20 sensory subscale

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

CIPN-20 sensory subscale

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).

Sensory loss

Finger and toe tactile sensitivity using monofilaments

Cold-induced pain

Finger cold sensitivity using thermode

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).

Full Information

NCT ID

NCT05452902

First Posted

July 6, 2022

Last Updated

September 21, 2023

Sponsor

University of Maryland, Baltimore

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05452902

Brief Title

Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

Official Title

The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2023 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. 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

Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy, Brain, Exercise, Nutrition

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EXCAP 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

CIPN-20 sensory subscale

Description

Time Frame

Time point 2 (approximately 6 weeks), controlling for baseline value

Secondary Outcome Measure Information:

Title

CIPN-20 sensory subscale

Description

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

Sensory, motor, and autonomic symptoms of CIPN

Description

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

Sensory loss

Description

Finger and toe tactile sensitivity using monofilaments

Time Frame

Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

Title

Cold-induced pain

Description

Finger cold sensitivity using thermode

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

Other Pre-specified Outcome Measures:

Title

Neuropsychological function

Description

Brain connectivity via functional magnetic resonance imaging

Time Frame

Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 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

Title

Musculoskeletal function

Description

Strength via handgrip 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria (subjects must…) Have a diagnosis of gastrointestinal cancer Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy Be able to read English Be ≥18 years Exclusion criteria (subjects must not…) Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat. 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. Have planned surgery or radiation treatment in the 12 weeks after baseline. Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not…) Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis) Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, 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

ian.kleckner@umaryland.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Javier Rosales, BS, MS

Phone

410-706-7391

jrosales@umaryland.edu

Facility Information:

Facility Name

University of Maryland Medical System

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

ian.kleckner@umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

First, we will conduct our primary analyses (Aims 1-4) on the data collected and publish our results with a group of researchers determined by the PI: Dr. Kleckner. Our team has already worked together to develop our study design, analysis plan, dissemination plan, etc. and we want to be the ones to publish our findings. Second, after the primary analyses (Aims 1-4) have been published (or at the discretion of the PI), we welcome collaboration with others who want to analyze our data as long as we are offered an opportunity for co-authorship and collaboration (not simply passing the data off to another research group). We may or may not accept the invitation for co-authorship depending on the timing and nature of the research. Third, if there are questions about the validity of our published findings and other research groups want to perform an independent analysis that they feel would be compromised by our co-authorship or collaboration, then we are open to that possibility.

IPD Sharing Time Frame

See above plan

IPD Sharing Access Criteria

Researchers analyzing our data must adhere to the following agreement (or similar), which will be presented in writing and signed and dated: They will not transfer the data to another party (i.e., all data requests come to the study PI, Dr. Kleckner) They will maintain the security and privacy of the data (secure data servers, password-protected computers, secure data transfer methods, etc.). They will acknowledge our funding sources that supported collection of the data (including this R21) They will offer collaboration and co-authorship unless that would be deemed inappropriate for ethical reasons (e.g., conducting an independent analysis) They will notify the study PI, Dr. Kleckner of dissemination (abstracts, manuscripts, etc.) They will provide regular updates to Dr. Kleckner on progress analyzing the data

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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