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NCT Number: 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

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.

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Key information

Conditions

Appendix Carcinoma Adenocarcinoma Adenoma Adenoma, Islet Cell Anal Carcinoma Anus Diseases Anus Neoplasms Appendiceal Neoplasms Carcinoma Carcinoma, Hepatocellular Cecal Diseases Cecal Neoplasms Colon Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Carcinoma Digestive System Diseases Digestive System Neoplasms Digestive System Neuroendocrine Tumor Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Carcinoma Esophageal Diseases Esophageal Neoplasms Gastric Carcinoma Gastro-enteropancreatic neuroendocrine tumor Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Liver and Intrahepatic Bile Duct Carcinoma Malignant Digestive System Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Pancreatic Neuroendocrine Tumor Rectal Carcinoma Rectal Diseases Rectal Neoplasms Small Intestinal Carcinoma Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture therapy

Procedure

Undergo acupuncture

Other names: Acupuncture

acupressure therapy

Procedure

Undergo acupressure

Other names: acupressure, Ischemic Compression

Oral Cryotherapy

Procedure

Undergo oral cryotherapy

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months

    Time frame: At 3 months

    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. 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. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.

Secondary outcomes

  1. Number of Participants With Grade 2 or Higher Chemotherapy-Induced Peripheral Neuropathy

    Time frame: 3 months

    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.

  2. Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure

    Time frame: 3 months

    The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms.

  3. Severity of CIPN: Tuning Fork Vibration Sensation Testing

    Time frame: 3 months

    A study-specific 128-Hz tuning fork will be used to assess vibration sensation on the great toe at baseline and 3 months. The time in seconds to loss of vibration sensation was measured. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN. The difference from baseline to 3 months in number of seconds to loss of vibration sensation was calculated for each patient. The differences were averaged across patients in each arm. The mean differences were compared between arms.

  4. Proportion of Patients Assigned to the Intervention Arm Who Complete 60% of Acupuncture Treatments

    Time frame: 3 months

    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.

  5. Change in Severity of Pain, Fatigue, Nausea, and Anxiety From Baseline to 3 Months

    Time frame: 3 months

    Measured by patient-reported National Cancer Institute [NCI] Patient Reported Outcomes [PRO]-CTCAE. The change in severity from baseline to 3 months was calculated and it ranged from -3 to 3. The severity was measured on a 0-3 (0=None, 3=Severe) scale with a higher value representing a worse outcome and a lower value representing a better outcome. This was done separately for pain, fatigue, nausea, and anxiety.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)
  • The Safeway Foundation

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2020
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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