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Cryotherapy + Acupressure + Acupuncture for Gastrointestinal Cancer
Phase 2
Waitlist Available
Led By Stacey Cohen
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >=18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing whether adding acupressure and acupuncture to oral cryotherapy helps decrease chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy.
Who is the study for?
This trial is for adults with various gastrointestinal cancers scheduled to receive specific chemotherapy regimens for at least 3 months. Participants must not be pregnant, have a certain level of white blood cells and platelets, and cannot have baseline peripheral neuropathy or recent acupuncture treatment.Check my eligibility
What is being tested?
The study compares the effectiveness of oral cryotherapy combined with acupressure and acupuncture versus oral cryotherapy alone in reducing nerve pain caused by oxaliplatin-based chemotherapy in patients with gastrointestinal cancer.See study design
What are the potential side effects?
Potential side effects may include discomfort from cold during oral cryotherapy, soreness or bruising at acupressure points or needle insertion sites from acupuncture, and general risks associated with these complementary therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Severity of chemotherapy-induced peripheral neuropathy (CIPN)
Secondary outcome measures
Incidence of grade 2 or higher CIPN
Incidence of pain, fatigue, nausea, and anxiety
Proportion of patients assigned to the intervention arm who complete 60% of acupuncture treatments
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (acupuncture, acupressure, cryotherapy)Experimental Treatment5 Interventions
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.
Group II: Arm II (cryotherapy)Active Control3 Interventions
Patients undergo standard of care oral cryotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture Therapy
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,076 Total Patients Enrolled
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,274 Total Patients Enrolled
The Safeway FoundationUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have GI cancer and am starting a specific chemotherapy plan for 3+ months.I can receive additional biological treatments with my chemotherapy.I have nerve damage in my hands or feet.I am set to receive a lower starting dose of oxaliplatin than the usual.Your platelet count is more than 20,000 per microliter.I am scheduled for treatment with oxaliplatin and capecitabine.I am taking duloxetine to help with nerve pain.I am 18 years old or older.I have received acupuncture in the last 3 months.You need to have a certain amount of a type of white blood cell called neutrophils.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (acupuncture, acupressure, cryotherapy)
- Group 2: Arm II (cryotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Oral Cryotherapy for use?
"The safety profile of Oral Cryotherapy has been evaluated and given a score of 2, since there is evidence to support it as safe but no data showing its efficacy yet."
Answered by AI
To what extent is the current research recruiting participants?
"Indeed, the study is currently open for participant enrollment. This trial was first listed on June 1st 2021 and has since been updated as recently as October 13th 2022 with a goal of recruiting 56 patients from one medical centre."
Answered by AI
Is enrollment for this trial currently open to the public?
"According to records on clinicaltrials.gov, this medical trial remains open for patient recruitment and has recently been updated as of October 13th 2022. It was initially posted on June 1st 2021."
Answered by AI
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