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

NCT04505553 | Completed Phase 2 Results FDA Device

• 4 other identifiers: RG1121095NCI-2020-05455P30CA01570410559
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months

  Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.

  At 3 months

Secondary Outcomes (5)

• Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy

  3 months

• Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure

  3 months

• Severity of CIPN: Tuning Fork Vibration Sensation Testing

  3 months

• Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments

  3 months

• Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months

  3 months

Study Arms (2)

Arm I (acupuncture, acupressure, cryotherapy)

EXPERIMENTAL

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.

Procedure: Acupuncture Therapy; Procedure: Acupressure Therapy; Procedure: Oral Cryotherapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Arm II (cryotherapy)

ACTIVE COMPARATOR

Patients undergo standard of care oral cryotherapy.

Procedure: Oral Cryotherapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (acupuncture, acupressure, cryotherapy); Arm II (cryotherapy)

Acupuncture Therapy PROCEDURE

Undergo acupuncture

Also known as: Acupuncture

Arm I (acupuncture, acupressure, cryotherapy)

Acupressure Therapy PROCEDURE

Undergo acupressure

Also known as: acupressure, Ischemic Compression

Arm I (acupuncture, acupressure, cryotherapy)

Oral Cryotherapy PROCEDURE

Undergo oral cryotherapy

Arm I (acupuncture, acupressure, cryotherapy); Arm II (cryotherapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (acupuncture, acupressure, cryotherapy); Arm II (cryotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator
• The Safeway Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Appendiceal Neoplasms; Colonic Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Carcinoma, Hepatocellular; Gastrointestinal Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms; Anus Neoplasms; Gastro-enteropancreatic neuroendocrine tumor; Adenoma, Islet Cell

Interventions

Acupuncture Therapy; Acupressure; Cryotherapy

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Colorectal Neoplasms; Colonic Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Rectal Diseases; Anus Diseases; Adenoma

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Stacey Cohen, MD
• Organization: University of Washington Medical Center - Montlake

sshovitz@fredhutch.org

2066066405

Study Officials

• Stacey Cohen

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 10, 2020
• Study Start: June 1, 2021
• Primary Completion: March 7, 2024
• Study Completion: March 31, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)