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Cryotherapy + Acupressure + Acupuncture for Gastrointestinal Cancer

Phase 2

Waitlist Available

Led By Stacey Cohen

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Be older than 18 years old

Must not have

Baseline peripheral neuropathy from any cause

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding acupressure and acupuncture to oral cryotherapy helps decrease chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy.

Who is the study for?

This trial is for adults with various gastrointestinal cancers scheduled to receive specific chemotherapy regimens for at least 3 months. Participants must not be pregnant, have a certain level of white blood cells and platelets, and cannot have baseline peripheral neuropathy or recent acupuncture treatment.

What is being tested?

The study compares the effectiveness of oral cryotherapy combined with acupressure and acupuncture versus oral cryotherapy alone in reducing nerve pain caused by oxaliplatin-based chemotherapy in patients with gastrointestinal cancer.

What are the potential side effects?

Potential side effects may include discomfort from cold during oral cryotherapy, soreness or bruising at acupressure points or needle insertion sites from acupuncture, and general risks associated with these complementary therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nerve damage in my hands or feet.

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I am set to receive a lower starting dose of oxaliplatin than the usual.

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I am scheduled for treatment with oxaliplatin and capecitabine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Severity of chemotherapy-induced peripheral neuropathy (CIPN)

Secondary study objectives

Incidence of grade 2 or higher CIPN

Incidence of pain, fatigue, nausea, and anxiety

Proportion of patients assigned to the intervention arm who complete 60% of acupuncture treatments

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (acupuncture, acupressure, cryotherapy)Experimental Treatment5 Interventions

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.

Group II: Arm II (cryotherapy)Active Control3 Interventions

Patients undergo standard of care oral cryotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral Cryotherapy

2021

Completed Phase 2

~80

Acupressure Therapy

2021