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

University of Washington

Status and phase: Completed; Phase 2

Conditions: Digestive System Carcinoma; Colon Carcinoma; Anal Carcinoma; Small Intestinal Carcinoma; Malignant Digestive System Neoplasm; Liver and Intrahepatic Bile Duct Carcinoma; Rectal Carcinoma; Digestive System Neuroendocrine Tumor; Esophageal Carcinoma; Gastric Carcinoma; Appendix Carcinoma; Pancreatic Neuroendocrine Tumor; Pancreatic Carcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04505553

RG1121095

NCI-2020-05455 (Registry Identifier)

10559 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Arm I (acupuncture, acupressure, cryotherapy)

Experimental group

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.

Treatment:

Procedure: Oral Cryotherapy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Acupuncture Therapy

Procedure: Acupressure Therapy

Arm II (cryotherapy)

Active Comparator group

Description:

Patients undergo standard of care oral cryotherapy.

Treatment:

Procedure: Oral Cryotherapy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment