Clinical trial NCT05916118: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluating the feasibility (adherence) of the intervention by patients
timeFrame: 14 weeks
measure: Evaluating the acceptability of the intervention by patients
timeFrame: 14 weeks
Secondary outcomes:
measure: Observe trends of exercise via questionnaires at various time points
timeFrame: 14 weeks
measure: Describe changes in quality of life via questionnaires
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
Study officials:
References: