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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04505553
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Nov 2025
Primary completion
Mar 7, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (acupuncture, acupressure, cryotherapy)
    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.
  • Active Comparator: Arm II (cryotherapy)
    Patients undergo standard of care oral cryotherapy.

Primary Outcome Measure

Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months [ Time Frame: At 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By condition
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By specialty
OncologyGI oncology
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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