Exercise and Oxaliplatin-induced Peripheral Neuropathy

Dartmouth Health

Status: Completed

Conditions: Peripheral Neuropathy

Treatments: Other: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05916118

STUDY02001529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Exercise and Oxaliplatin-induced peripheral neuropathy

Experimental group

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.

Treatment:

Other: Aerobic Exercise