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Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04888988
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Po-Ju Lin, University of Rochester NCORP Research Base

Study Description
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Brief Summary:
This phase II trial studies whether using exercise is better than the usual approach for treating chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy damages the nerves communicating between the brain, spinal cord, and the rest of the body. The usual approach for treating CIPN is treatment with drugs that help reduce symptoms of other types of neuropathy (for example, from diabetes). However, these drugs do not treat all symptoms of CIPN. Exercise may help to reduce CIPN symptoms.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Peripheral Neuropathy Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Exercise Intervention Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. Assess the preliminary efficacy of exercise versus (vs.) standard care for treating CIPN (via patient-reported CIPN-20 total score).

SECONDARY OBJECTIVES:

I. Assess the preliminary efficacy of exercise vs. standard care on individual symptoms of CIPN (via CIPN Symptom Inventory; i.e., numbness, tingling, burning/shooting pain, and cramping in the hands and feet).

II. Assess the preliminary efficacy of exercise vs. standard care on a clinical test of CIPN symptoms (via the tactile sensitivity in the fingers and toes).

III. Assess the effects of exercise vs. standard care on two possible CIPN mechanisms:

IIIa. Interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire).

IIIb. Inflammation (via serum cytokines IL6, IL-10, and IL-1beta, and prostaglandins PGF2alpha and 6-Keto PGF1 alpha).

EXPLORATORY OBJECTIVES:

I. Assess the effects of exercise vs. standard care on other common symptoms related to cancer, chemotherapy, and CIPN, including:

Ia. Daily Diary of symptoms of CIPN. Ib. An array of cancer and treatment symptoms (MD Anderson Symptom Inventory; MDASI).

Ic. Anxiety and depression (hospital anxiety and depression scale; HADS). Id. Pain catastrophizing (pain catastrophizing scale; PCS). Ie. Cognitive impairment (Functional Assessment of Cancer Therapy-Cognitive [FACT-Cog]).

If. Fatigue (brief fatigue inventory; BFI). Ig. Quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]), and coronavirus epidemic (coronavirus disease [COVID] effects).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1 (EXERCISE): Patients undergo the exercise for cancer patients (EXCAP) intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Patients also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, patients meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5.

ARM 2 (CONTROL): Patients receive usual care for 6 weeks. At the end of the study, patients may receive the exercise kit and complete the EXCAP program as in Arm 1. Patients also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Actual Study Start Date : February 25, 2022
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 (EXCAP exercise)
Patients undergo the EXCAP exercise intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. In addition, patients meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5.
 Other: Exercise Intervention
Participate in the EXCAP exercise program (meeting with a counselor, receive follow-up meetings)
No Intervention: Arm 2 (usual care)
Patients receive usual care for 6 weeks. At the end of the study, patients may receive the exercise kit and complete the EXCAP program as in Arm 1.


Outcome Measures
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Primary Outcome Measures :
  1. Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity [ Time Frame: Week 6 post randomization ]
    Will estimate the effects of exercise versus usual care on CIPN using analysis of covariance (ANCOVA). Will be measured by the mean European Organization for Research and Treatment of Cancer-CIPN20. The model will include CIPN-20 at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest and the pre-intervention CIPN-20 score as a covariate.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of cancer
  • Be receiving neurotoxic chemotherapy or have completed neurotoxic chemotherapy in the past nine months (i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy)
  • Report two or more symptoms of CIPN at a level of >= 4 on the CIPN symptom inventory on the Screening Form
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Have at least six months life expectancy
  • Be at least 18 years of age
  • Be able to read and understand English
  • Be able to provide written informed consent

Exclusion Criteria:

  • Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program, according to the patient's physician (e.g., oncologist, primary care) or physician's designee
  • Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form
  • Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888988


Contacts
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Contact: Alexandra O'Connell 585.275.1067 URCC_19075@URMC.Rochester.edu

Locations
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United States, Illinois
Heartland NCORP Recruiting
Decatur, Illinois, United States, 62526
Contact: Peggy Wisher    217-876-6618    wisher.peggy@mhsil.com   
United States, Ohio
Dayton Clinical Oncology Program Not yet recruiting
Dayton, Ohio, United States, 45459
Contact: Mary Ontko    937-775-1350    mary.ontko@daytonncorp.org   
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ian R Kleckner University of Rochester NCORP Research Base
More Information
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Responsible Party: Po-Ju Lin, Research Assistant Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT04888988    
Other Study ID Numbers: URCC19075
NCI-2020-11456 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC19075 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-19075 ( Other Identifier: DCP )
URCC-19075 ( Other Identifier: CTEP )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases