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

Pancreatic Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04505553
• Other study ID #: RG1121095
• Secondary ID: NCI-2020-05455P3
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Carcinoma
• Appendix Carcinoma
• Carcinoma
• Colon Carcinoma
• Digestive System Carcinoma
• Digestive System Neoplasms
• Digestive System Neuroendocrine Tumor
• Esophageal Carcinoma
• Esophageal Neoplasms
• Gastric Carcinoma
• Gastrointestinal Neoplasms
• Liver and Intrahepatic Bile Duct Carcinoma
• Malignant Digestive System Neoplasm
• Neuroendocrine Tumors
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Pancreatic Neuroendocrine Tumor
• Peripheral Nervous System Diseases
• Rectal Carcinoma
• Small Intestinal Carcinoma
• Stomach Neoplasms

Intervention

Procedure:
• Acupuncture Therapy
Undergo acupuncture
• Acupressure Therapy
Undergo acupressure
• Oral Cryotherapy
Undergo oral cryotherapy

Other:
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI), The Safeway Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of chemotherapy-induced peripheral neuropathy (CIPN)	Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.	At 3 months
Secondary	Incidence of grade 2 or higher CIPN	Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate.	3 months
Secondary	Severity of CIPN: Neuropen assessment of patients' perceived pain and pressure	The Neuropen is used to assess touch and pressure perception as well as protective pain and sharpness sensation. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the 40-g Neurotip on the dominant foot. Loss of pain and pressure sensation are associated with increased CIPN.	3 months
Secondary	Severity of CIPN: Tuning fork vibration sensation testing	A study-specific 128-Hz tuning fork will be used to assess vibration sensation on dominant lower extremity and dominant upper extremity sites. If the patient feels the vibration for 15 seconds or longer, this is defined as normal. If the patient feels the vibration less than 15 seconds, this is defined as absent or decreased vibration sensation. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN.	3 months
Secondary	Proportion of patients assigned to the intervention arm who complete 60% of acupuncture treatments	Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted.	3 months
Secondary	Incidence of pain, fatigue, nausea, and anxiety	Measured by patient-reported (National Cancer Institute [NCI] Patient Reported Outcomes [PRO]-CTCAE, Brief Pain Inventory [BPI], oral dysesthesia) and provider-assessed (CTCAE version 5) grading scales.	3 months