AzTrials
AzTrials

Appendix CarcinomaPhase 2NCT04505553

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

A Phase 2 study testing Acupuncture Therapy, Acupressure Therapy and Oral Cryotherapy in people with Appendix Carcinoma and Colon Carcinoma, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acupuncture Therapy, Acupressure Therapy and Oral Cryotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to 31 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Acupuncture Therapy, Acupressure Therapy, Oral Cryotherapy, Questionnaire Administration, Quality-of-Life Assessment
Medical subject headings
Appendiceal Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture TherapyProcedure or surgery

    Also called Acupuncture

    Undergo acupuncture

  • Acupressure TherapyProcedure or surgery

    Also called acupressure, Ischemic Compression

    Undergo acupressure

  • Oral CryotherapyProcedure or surgery

    Undergo oral cryotherapy

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT04505553
Study groupRoleWhat they receive
Arm I (acupuncture, acupressure, cryotherapy)ExperimentalPatients 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.
Receives: Procedure: Acupuncture Therapy; Procedure: Acupressure Therapy; Procedure: Oral Cryotherapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm II (cryotherapy)Active comparatorPatients undergo standard of care oral cryotherapy.
Receives: Procedure: Oral Cryotherapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At 3 months

Secondary outcomes (5)

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

    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.

    Measured: 3 months

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

    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.

    Measured: 3 months

  3. Severity of CIPN: Tuning Fork Vibration Sensation Testing

    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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start1 Jun 2021
  3. Primary completion7 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04505553
Sponsor's protocol ID
RG1121095
Other IDs
NCI-2020-05455, P30CA015704, 10559
Status last verified
Nov 2025
First submitted
31 Jul 2020
Last updated
21 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acupuncture Therapy, Acupressure Therapy and Oral Cryotherapy in people with Appendix Carcinoma and Colon Carcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04505553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in