Oral Cryotherapy for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma+20 More
Oral Cryotherapy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Carcinoma
  • Colon Carcinoma
  • Esophageal Carcinoma
  • Cancer, Anal
  • Digestive System Neuroendocrine Tumor
  • Malignant Digestive System Neoplasm
  • Rectal Carcinoma
  • Progressive Neuroendocrine Tumors of pancreatic origin
  • Gastric Carcinoma
  • Small Intestinal Carcinoma
  • Digestive System Carcinoma
  • Liver
  • Appendix

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 3 months

3 months
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
Severity of CIPN: Neuropen assessment of patients' perceived pain and pressure
Severity of CIPN: Tuning fork vibration sensation testing
At 3 months
Severity of chemotherapy-induced peripheral neuropathy (CIPN)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma

Trial Design

2 Treatment Groups

Arm II (cryotherapy)
1 of 2
Arm I (acupuncture, acupressure, cryotherapy)
1 of 2
Active Control
Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: Oral Cryotherapy · No Placebo Group · Phase 2

Arm I (acupuncture, acupressure, cryotherapy)Experimental Group · 5 Interventions: Oral Cryotherapy, Acupressure Therapy, Acupuncture Therapy, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Procedure, Procedure, Procedure, Other, Other
Arm II (cryotherapy)ActiveComparator Group · 3 Interventions: Oral Cryotherapy, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Procedure, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture Therapy
2018
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,583 Previous Clinical Trials
1,565,930 Total Patients Enrolled
47 Trials studying Carcinoma
4,060 Patients Enrolled for Carcinoma
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,832 Total Patients Enrolled
1,306 Trials studying Carcinoma
389,699 Patients Enrolled for Carcinoma
The Safeway FoundationUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
Stacey CohenPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Carcinoma
27 Patients Enrolled for Carcinoma

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Platelet count This condition is characterized by a platelet count that is greater than or equal to 20 thousand per microliter.
People with GI cancer who are scheduled to start receiving a new regimen of fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOX, FOLFIRINOX, or FOLFOXIRI) may participate in this study
A person has an absolute neutrophil count of more than 0.5 thousand per microliter if they have more than 0.5 thousand neutrophils in every microliter of their blood.
to participate in a human research study indicates that a person understands the risks and benefits of the study
The addition of a biologic agent to one of the chemotherapy regimens listed above is not limited, and can include bevacizumab, cetuximab, panitumumab, trastuzumab, or the biosimilars of these agents.
I am not pregnant.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.