Back to resultsExercise and Oxaliplatin-induced Peripheral Neuropathy
Primary Purpose
Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria: Receiving care at Dartmouth-Hitchcock Medical Center in Lebanon, NH Age >18 years Eastern Cooperative Oncology Group Status 0 to 2; Diagnosed gastrointestinal cancer of any stage Scheduled to receive at least 4 cycles of oxaliplatin Complete the International Physical Activity Questionnaire score equal to or greater than 99 MET minutes/week (equivalent to ~30 minutes of walking) Have mediport access prior to enrollment in the study Exclusion Criteria: Exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the EMR (electronic medical record) past medical history and/or based on consultation with the medical oncologist; Scheduled major surgery during the study time period; Pre-existing peripheral neuropathy prior to chemotherapy; Patient with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator; Prior history of treatment with oxaliplatin, docetaxel, or paclitaxel Pregnant women; Prisoners; Inability to read or speak English/unable to consent; Prognosis of less than six months
Sites / Locations
- Dartmouth-Hitchcock Medical Center
- Dartmouth Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise and Oxaliplatin-induced peripheral neuropathy
Arm Description
A single arm to evaluate the feasibility and acceptability of having patients exercise during oxaliplatin infusions in the infusion center. Arm will enroll patients receiving oxaliplatin-containing chemotherapy for gastrointestinal cancer or for cancer of unknown primary.
Outcomes
Primary Outcome Measures
Evaluating the feasibility (adherence) of the intervention by patients
70% of patients completing >60% of the exercise sessions during all infusion session
60% of patients identifying "agree" or "strongly agree" on the Feasibility of Intervention Measure (FIM), a validated instrument
Evaluating the acceptability of the intervention by patients
≥60% of patients identifying "agree" or "strongly agree" on the Acceptability of Intervention Measure (AIM), a validated instrument
Secondary Outcome Measures
Observe trends of exercise via questionnaires at various time points
Observe trends of exercise on patient-reported chemotherapy-induced peripheral neuropathy (via EORTC-QLQ-CIPN20) over time: at baseline, ~6-8 weeks from treatment initiation, and ~12-14 weeks from treatment initiation
Describe changes in quality of life via questionnaires
Describe changes in quality of life (via PROMIS-29 QOL) over time: at baseline, ~6-8 weeks from treatment initiation, and ~12-14 weeks from treatment initiation.
Full Information
NCT ID
NCT05916118
First Posted
June 13, 2023
Last Updated
July 12, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05916118
Brief Title
Exercise and Oxaliplatin-induced Peripheral Neuropathy
Official Title
A Phase I, Pilot Study, Single-group Investigating the Feasibility of Exercise During Oxaliplatin Infusions.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
June 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single group study was conducted to test the feasibility and acceptability of implementing an exercise intervention during oxaliplatin infusion across three months of oxalipatin-based chemotherapy in patients with gastrointestinal malignancies.10 patients were enrolled onto this study and validated questionnaires were used to evaluate the feasibility and acceptability of the intervention and collect patient-reported outcomes over the course of study enrollment.
Detailed Description
The proposed study is a single arm study to evaluate the feasibility and acceptability of having patients exercise while receiving oxaliplatin infusions in the infusion center. The study will enroll patients receiving oxaliplatin-containing chemotherapy for gastrointestinal cancersor for cancer of unknown primary.
Patients will be provided with a wrist heart rate monitors to be used during the infusions. They will wear the heart monitors during the entirety of the oxaliplatin chemotherapy infusion. Patients will be asked to engage in aerobic exercise using a pedal machine to move their arms and legs while in a seated position. Patients will be asked to exercise for a total of 30 minutes, which will be divided into three, ten minute bouts of exercise, spaced out in 30 minute blocks of time.
The comprehensive surveys including EORTC-QLC-CIPN20 and PROMIS-29 QOL will be completed at baseline, ~6-8 weeks into treatment, and at ~12-14 weeks after treatment initiation. The feasibility and acceptability instruments will be administered ~6-8 weeks into treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise and Oxaliplatin-induced peripheral neuropathy
Arm Type
Experimental
Arm Description
A single arm to evaluate the feasibility and acceptability of having patients exercise during oxaliplatin infusions in the infusion center. Arm will enroll patients receiving oxaliplatin-containing chemotherapy for gastrointestinal cancer or for cancer of unknown primary.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
Patients will be asked to engage in aerobic exercise using a pedal machine to move their arms and legs while in a seated position. Patients will be asked to exercise for a total of 30 minutes, which may be divided in up to three, ten-minute bouts of exercise.
Primary Outcome Measure Information:
Title
Evaluating the feasibility (adherence) of the intervention by patients
Description
70% of patients completing >60% of the exercise sessions during all infusion session
60% of patients identifying "agree" or "strongly agree" on the Feasibility of Intervention Measure (FIM), a validated instrument
Time Frame
14 weeks
Title
Evaluating the acceptability of the intervention by patients
Description
≥60% of patients identifying "agree" or "strongly agree" on the Acceptability of Intervention Measure (AIM), a validated instrument
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Observe trends of exercise via questionnaires at various time points
Description
Observe trends of exercise on patient-reported chemotherapy-induced peripheral neuropathy (via EORTC-QLQ-CIPN20) over time: at baseline, ~6-8 weeks from treatment initiation, and ~12-14 weeks from treatment initiation
Time Frame
14 weeks
Title
Describe changes in quality of life via questionnaires
Description
Describe changes in quality of life (via PROMIS-29 QOL) over time: at baseline, ~6-8 weeks from treatment initiation, and ~12-14 weeks from treatment initiation.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving care at Dartmouth-Hitchcock Medical Center in Lebanon, NH
Age >18 years
Eastern Cooperative Oncology Group Status 0 to 2;
Diagnosed gastrointestinal cancer of any stage
Scheduled to receive at least 4 cycles of oxaliplatin
Complete the International Physical Activity Questionnaire score equal to or greater than 99 MET minutes/week (equivalent to ~30 minutes of walking)
Have mediport access prior to enrollment in the study
Exclusion Criteria:
Exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the EMR (electronic medical record) past medical history and/or based on consultation with the medical oncologist;
Scheduled major surgery during the study time period;
Pre-existing peripheral neuropathy prior to chemotherapy;
Patient with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator;
Prior history of treatment with oxaliplatin, docetaxel, or paclitaxel
Pregnant women;
Prisoners;
Inability to read or speak English/unable to consent;
Prognosis of less than six months
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dartmouth Health
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exercise and Oxaliplatin-induced Peripheral Neuropathy
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