Out of time and study resources

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

Inclusion criteria (subjects must…)

1. Have a diagnosis of cancer
2. Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy
3. Be able to read English
4. Be ≥18 years

Exclusion criteria (subjects must not…)

1. Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat.
2. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
3. Have planned surgery or radiation treatment in the 12 weeks after baseline.

Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not…)

1. Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
2. Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)

• First, we will conduct our primary analyses (Aims 1-4) on the data collected and publish our results with a group of researchers determined by the PI: Dr. Kleckner. Our team has already worked together to develop our study design, analysis plan, dissemination plan, etc. and we want to be the ones to publish our findings.
• Second, after the primary analyses (Aims 1-4) have been published (or at the discretion of the PI), we welcome collaboration with others who want to analyze our data as long as we are offered an opportunity for co-authorship and collaboration (not simply passing the data off to another research group). We may or may not accept the invitation for co-authorship depending on the timing and nature of the research.
• Third, if there are questions about the validity of our published findings and other research groups want to perform an independent analysis that they feel would be compromised by our co-authorship or collaboration, then we are open to that possibility.

See above plan

Researchers analyzing our data must adhere to the following agreement (or similar), which will be presented in writing and signed and dated:

• They will not transfer the data to another party (i.e., all data requests come to the study PI, Dr. Kleckner)
• They will maintain the security and privacy of the data (secure data servers, password-protected computers, secure data transfer methods, etc.).
• They will acknowledge our funding sources that supported collection of the data (including this R21)
• They will offer collaboration and co-authorship unless that would be deemed inappropriate for ethical reasons (e.g., conducting an independent analysis)
• They will notify the study PI, Dr. Kleckner of dissemination (abstracts, manuscripts, etc.)
• They will provide regular updates to Dr. Kleckner on progress analyzing the data