Exercise and Oxaliplatin-induced Peripheral Neuropathy

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Other: Aerobic Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Receiving care at Dartmouth-Hitchcock Medical Center in Lebanon, NH
2. Age >18 years
3. Eastern Cooperative Oncology Group Status 0 to 2;
4. Diagnosed gastrointestinal cancer of any stage
5. Scheduled to receive at least 4 cycles of oxaliplatin
6. Complete the International Physical Activity Questionnaire score equal to or greater than 99 MET minutes/week (equivalent to ~30 minutes of walking)
7. Have mediport access prior to enrollment in the study

Exclusion Criteria:

1. 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;
2. Scheduled major surgery during the study time period;
3. Pre-existing peripheral neuropathy prior to chemotherapy;
4. 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;
5. Prior history of treatment with oxaliplatin, docetaxel, or paclitaxel
6. Pregnant women;
7. Prisoners;
8. Inability to read or speak English/unable to consent;
9. Prognosis of less than six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and Oxaliplatin-induced peripheral neuropathy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: STUDY02001529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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