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

Primary Purpose

Appendix Carcinoma, Colon Carcinoma, Esophageal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture Therapy
Acupressure Therapy
Oral Cryotherapy
Questionnaire Administration
Quality-of-Life Assessment
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Appendix Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

  • 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

Sites / Locations

  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (acupuncture, acupressure, cryotherapy)

Arm II (cryotherapy)

Arm 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.

Patients undergo standard of care oral cryotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
July 31, 2020
Last Updated
May 4, 2023
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI), The Safeway Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04505553
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
August 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI), The Safeway Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (acupuncture, acupressure, cryotherapy)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (cryotherapy)
Arm Type
Active Comparator
Arm Description
Patients undergo standard of care oral cryotherapy.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture Therapy
Other Intervention Name(s)
Acupuncture
Intervention Description
Undergo acupuncture
Intervention Type
Procedure
Intervention Name(s)
Acupressure Therapy
Other Intervention Name(s)
acupressure, Ischemic Compression
Intervention Description
Undergo acupressure
Intervention Type
Procedure
Intervention Name(s)
Oral Cryotherapy
Intervention Description
Undergo oral cryotherapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Severity of chemotherapy-induced peripheral neuropathy (CIPN)
Description
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.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Incidence of grade 2 or higher CIPN
Description
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.
Time Frame
3 months
Title
Severity of CIPN: Neuropen assessment of patients' perceived pain and pressure
Description
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.
Time Frame
3 months
Title
Severity of CIPN: Tuning fork vibration sensation testing
Description
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.
Time Frame
3 months
Title
Proportion of patients assigned to the intervention arm who complete 60% of acupuncture treatments
Description
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.
Time Frame
3 months
Title
Incidence of pain, fatigue, nausea, and anxiety
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Daniels
Phone
206-606-6347
Email
giresearch@seattlecca.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Jones
Phone
206-606-7350
Email
giresearch@seattlecca.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Cohen
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Daniels
Phone
206-606-6347
Email
giresearch@seattlecca.org
First Name & Middle Initial & Last Name & Degree
Kate Jones
Phone
206-606-7350
Email
giresearch@seattlecca.org
First Name & Middle Initial & Last Name & Degree
Stacey Cohen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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