Exercise and Oxaliplatin-induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I, Pilot Study, Single-group Investigating the Feasibility of Exercise During Oxaliplatin Infusions.

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Other: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and Oxaliplatin-induced peripheral neuropathy<br>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. | Other: Aerobic Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 weeks | 
| 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 | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 weeks | 
| 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. | 14 weeks |