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Clinical Trial 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 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.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms

  • Anal Carcinoma
  • Appendix Carcinoma
  • Carcinoma
  • Colon Carcinoma
  • Digestive System Carcinoma
  • Digestive System Neoplasms
  • Digestive System Neuroendocrine Tumor
  • Esophageal Carcinoma
  • Esophageal Neoplasms
  • Gastric Carcinoma
  • Gastrointestinal Neoplasms
  • Liver and Intrahepatic Bile Duct Carcinoma
  • Malignant Digestive System Neoplasm
  • Neuroendocrine Tumors
  • Pancreatic Carcinoma
  • Pancreatic Neoplasms
  • Pancreatic Neuroendocrine Tumor
  • Peripheral Nervous System Diseases
  • Rectal Carcinoma
  • Small Intestinal Carcinoma
  • Stomach Neoplasms

NCT number NCT04505553
Study type Interventional
Source University of Washington
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 1, 2021
Completion date September 30, 2024

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