NCT04505553

Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer

Pilot Study of Oral Cryotherapy vs. Oral Cryotherapy Plus Acupuncture and Acupressure to Decrease Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy for GI Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Acupuncture Therapy	Undergo acupuncture
PROCEDURE	Acupressure Therapy	Undergo acupressure
PROCEDURE	Oral Cryotherapy	Undergo oral cryotherapy
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-03-07
• Completion: 2024-03-31
• First posted: 2020-08-10
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study