Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
Appendix Carcinoma, Colon Carcinoma, Esophageal Carcinoma
About this trial
This is an interventional supportive care trial for Appendix Carcinoma
Eligibility Criteria
Inclusion Criteria:
GI cancer (primary esophagus, gastric, pancreas, biliary, liver, small bowel, appendix, colon, rectal, anal, or gastrointestinal/pancreatic neuroendocrine tumor) scheduled to receive a new start of fluorouracil (5-FU), oxaliplatin, +/- irinotecan (fluorouracil/leucovorin calcium/oxaliplatin [FOLFOX], fluorouracil/irinotecan/leucovorin calcium/oxaliplatin [FOLFIRINOX], leucovorin/fluorouracil/oxaliplatin/irinotecan [FOLFOXIRI] regimens) with plan for >= 3 months of therapy with the regimen. Chemotherapy can be given for neoadjuvant, adjuvant, or palliative intent. 1 dose (cycle) of the intended regimen is permitted prior to study enrollment.
** There is no limitation on the addition of a biologic agent to one of the above chemotherapy regimens, including, but not limited to: bevacizumab, cetuximab, panitumumab, trastuzumab, or the biosimilars of these agents
- Absolute neutrophil count > 0.5 thousand/microL
- Platelet count > 20 thousand/microL
- Not currently pregnant
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Baseline peripheral neuropathy from any cause
- Planned oxaliplatin with capecitabine
- Planned initial dose of oxaliplatin < 100% of the standard regimen-specified dose. For most regimens, this would be 85 mg/m^2 intravenously (IV) dosed every 14 days
- Receipt of acupuncture treatment in the prior 3 months
- Use of concomitant duloxetine for minimization of neuropathy
- Psychiatric illness/social situations that would limit compliance with study requirements
Sites / Locations
- Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (acupuncture, acupressure, cryotherapy)
Arm II (cryotherapy)
Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.
Patients undergo standard of care oral cryotherapy.