Exercise and Oxaliplatin-induced Peripheral Neuropathy

NCT05916118 | Completed

• 1 other identifier: STUDY02001529
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Observe trends of exercise via questionnaires at various time points

  14 weeks

• Describe changes in quality of life via questionnaires

  14 weeks

Study Arms (1)

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.

Other: Aerobic Exercise

Interventions

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.

Exercise and Oxaliplatin-induced peripheral neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Scheduled major surgery during the study time period;
• Pre-existing peripheral neuropathy prior to chemotherapy;
• 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;
• Prior history of treatment with oxaliplatin, docetaxel, or paclitaxel
• Pregnant women;
• Prisoners;
• Inability to read or speak English/unable to consent;
• Prognosis of less than six months

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Dartmouth Health

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 23, 2023
• Study Start: October 24, 2022
• Primary Completion: May 19, 2023
• Study Completion: June 25, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

US (2)