Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Washington
With
National Cancer Institute (NCI)
The Safeway Foundation
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: Patients undergo standard of care oral cryotherapy.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Age \>=18 years
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
You may not be if
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
Clareo Health | Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
