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

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.

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• The Safeway Foundation

  collaborator UNKNOWN

• University of Washington

  lead OTHER

Principal Investigators

• Stacey Cohen · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2024-03-07

Completion

2024-03-31

FDA Device

Yes

Countries

• United States

Study Locations