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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and Oxaliplatin-induced peripheral neuropathy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the feasibility (adherence) of the intervention by patients |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States | ||
| Dartmouth Health |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
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 |
| Lebanon |
| New Hampshire |
| 03766 |
| United States |