Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
Completed · Phase 2
Conditions studied: Appendix Carcinoma, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Malignant Digestive System Neoplasm, Pancreatic Carcinoma, Rectal Carcinoma, Small Intestinal Carcinoma, Anal Carcinoma, Digestive System Carcinoma, Digestive System Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor
In brief
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 patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.
Key facts
- Study ID
- NCT04505553
- Run by
- University of Washington
- People needed
- 78
- Starts
- 2021-06-01
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.