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

Pilot Study of Oral Cryotherapy vs. Oral Cryotherapy Plus Acupuncture and Acupressure to Decrease Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy for GI Cancers

Sponsors

Lead Sponsor: University of Washington

Collaborator: National Cancer Institute (NCI)
The Safeway Foundation

Source University of Washington
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.

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: 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. ARM II: Patients undergo standard of care oral cryotherapy.

Overall Status Recruiting
Start Date 2021-06-01
Completion Date 2022-02-25
Primary Completion Date 2022-02-25
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Severity of chemotherapy-induced peripheral neuropathy (CIPN) At 3 months
Secondary Outcome
Measure Time Frame
Incidence of grade 2 or higher CIPN 3 months
Severity of CIPN: Neuropen assessment of patients' perceived pain and 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
Incidence of pain, fatigue, nausea, and anxiety 3 months
Enrollment 56
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Acupuncture Therapy

Description: Undergo acupuncture

Arm Group Label: Arm I (acupuncture, acupressure, cryotherapy)

Other Name: Acupuncture

Intervention Type: Procedure

Intervention Name: Acupressure Therapy

Description: Undergo acupressure

Arm Group Label: Arm I (acupuncture, acupressure, cryotherapy)

Intervention Type: Procedure

Intervention Name: Oral Cryotherapy

Description: Undergo oral cryotherapy

Intervention Type: Other

Intervention Name: Questionnaire Administration

Description: Ancillary studies

Intervention Type: Other

Intervention Name: Quality-of-Life Assessment

Description: Ancillary studies

Other Name: Quality of Life Assessment

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 - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Stacey Cohen Principal Investigator Fred Hutch/University of Washington Cancer Consortium
Overall Contact

Last Name: Taylor Vlaming

Phone: 206-606-2004

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Fred Hutch/University of Washington Cancer Consortium Taylor Vlaming 206-606-2004 [email protected] Stacey Cohen Principal Investigator
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm I (acupuncture, acupressure, cryotherapy)

Type: Experimental

Description: 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.

Label: Arm II (cryotherapy)

Type: Active Comparator

Description: Patients undergo standard of care oral cryotherapy.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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