Exercise and Oxaliplatin-induced Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05916118
• Other study ID #: STUDY02001529
• Status: Completed
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: June 25, 2023

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 25, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth Health	Lebanon	New Hampshire
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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