NCT03329131

Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

Completed NA Results posted Last updated 16 October 2024

What this trial tests

NA trial testing Cryotherapy in Peripheral Neuropathies in 12 participants. Completed in 21 September 2020.

Timeline

13 November 2017

Primary endpoint
21 September 2020

21 September 2020

Quick facts

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	12
Start date	13 November 2017
Primary completion	21 September 2020
Estimated completion	21 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Cryotherapy (CRYOTHERAPY) — full drug profile →

Conditions studied

• Peripheral Neuropathies — all drugs for Peripheral Neuropathies →

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

18 and older, any sex, with Peripheral Neuropathies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Prevention of Peripheral Neuropathy During Taxane Chemotherapy Primary · Change from baseline to 6 months post chemo (up to 14 months)

A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score ind

Group	Value	95% CI
Cryotherapy	7.28	0 – 29

Evaluate Safety of Cryotherapy Use Primary · Baseline to 6 months post Cryotherapy (up to 14 months)

Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes

Group	Value	95% CI
Cryotherapy	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cryotherapy

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (12 terms — click to expand)

Reaction	System	Cryotherapy
Peripheral neuropathy	Nervous system disorders	—
Fever	General disorders	—
Fatigue	General disorders	—
Myalgia	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Rash on hands	Skin and subcutaneous tissue disorders	—
Bone pain	General disorders	—
Dry skin on feet	Skin and subcutaneous tissue disorders	—
Anxiety	General disorders	—
Nail bed changes	Skin and subcutaneous tissue disorders	—
Rectal bleeding	Gastrointestinal disorders	—
Nail bed loss	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03329131 adverse events section.

Sponsor's own description

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-Analgesic Symptomatic or Disease-Modifying Potential of TRPA1.
   Heber S, Fischer MJM. · · 2019 · cited 9× · PMID 31547502 · DOI 10.3390/medsci7100099