Clinical trial NCT04505553: Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Appendix Carcinoma
Colon Carcinoma
Esophageal Carcinoma
Gastric Carcinoma
Liver and Intrahepatic Bile Duct Carcinoma
Malignant Digestive System Neoplasm
Pancreatic Carcinoma
Rectal Carcinoma
Small Intestinal Carcinoma
Anal Carcinoma
Digestive System Carcinoma
Digestive System Neuroendocrine Tumor
Pancreatic Neuroendocrine Tumor
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The Safeway Foundation
First posted: 2020-08-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Severity of chemotherapy-induced peripheral neuropathy (CIPN)
timeFrame: At 3 months
Secondary outcomes:
measure: Incidence of grade 2 or higher CIPN
timeFrame: 3 months
measure: Severity of CIPN: Neuropen assessment of patients' perceived pain and pressure
timeFrame: 3 months
measure: Severity of CIPN: Tuning fork vibration sensation testing
timeFrame: 3 months
measure: Proportion of patients assigned to the intervention arm who complete 60% of acupuncture treatments
timeFrame: 3 months
measure: Incidence of pain, fatigue, nausea, and anxiety
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Stacey Cohen
role: PRINCIPAL_INVESTIGATOR
References: