Status:
COMPLETED
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
The Safeway Foundation
Conditions:
Appendix Carcinoma
Colon Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patien...
Detailed Description
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 infu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04505553
Start Date
June 1 2021
End Date
March 31 2024
Last Update
October 28 2024
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109