Phase 2 N=78 Randomized Supportive Care

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

Appendix Carcinoma · Colon Carcinoma · Esophageal Carcinoma · Gastric Carcinoma · Liver and Intrahepatic Bile Duct Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT04505553 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months — 5.9; 9.1; 1.9; 5.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acupuncture Therapy (Procedure); Acupressure Therapy (Procedure); Oral Cryotherapy (Procedure); Questionnaire Administration (Other); Quality-of-Life Assessment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months	5.9; 9.1; 1.9; 5.7; 0.6; 0.8	—
SECONDARY Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy	28; 33; 5; 3	—
SECONDARY Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure	-1.0; -0.7	—
SECONDARY Severity of CIPN: Tuning Fork Vibration Sensation Testing	-5.0; 0.1	—
SECONDARY Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments	23; 10	—
SECONDARY Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months	-0.3; -0.3; -0.1; 0.4; -0.3; 0.3	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04505553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.