Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome

Breast Carcinoma Clinical Trial

Official title:

Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640053
• Other study ID #: RU221511I
• Secondary ID: NCI-2015-02014RU
• Status: Completed
• Phase: N/A
• Start date: December 23, 2015
• Est. completion date: October 5, 2018

Study information

• Verified date: June 2019
• Source: Academic and Community Cancer Research United
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with ice bags) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy is being studied to see if it can help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.

Description:

PRIMARY OBJECTIVES:

I. To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy.

II. To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain syndrome (P-APS).

III. To examine the possible relative toxicities related to topical cryotherapy in this study situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply bags filled with crushed ice to hands and feet for 15 minutes before, for 60 minutes during administration, and for 15 minutes after finishing administration of paclitaxel.

ARM II: Patients receive paclitaxel intravenously (IV) over 60 minutes on weeks 1-12.

In both arms, courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 30 days for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 5, 2018
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to complete questionnaires by themselves or with assistance

• Planned paclitaxel at a dose of 80 mg/m^2 intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution

• Life expectancy > 6 months

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Patient has score of 0 or 1 on the neurotoxicity evaluation, as determined by the healthcare provider

Exclusion Criteria:

• Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause

• Diagnosis of fibromyalgia

• Any prior exposure to neurotoxic chemotherapy

• History of Raynaud?s disease, cryoglobulinemia

Related Conditions & MeSH terms

• Acute Pain
• Breast Carcinoma
• Breast Neoplasms
• Peripheral Nervous System Diseases

Intervention

Procedure:
• Cryotherapy
Applied topically

Drug:
• Paclitaxel
Given IV

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Bon Secours Saint Francis Hospital	Charleston	South Carolina
United States	Cancer Research Consortium of West Michigan NCORP	Grand Rapids	Michigan
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic	Rochester	Minnesota
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Carle Cancer Center NCI Community Oncology Research Program	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Academic and Community Cancer Research United	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) EORTC CIPN20 Sensory Neuropathy Subscale Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale adjusting for baseline. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline Sensory Neuropathy subscale score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Primary	Area Under the Curve (AUC) EORTC CIPN20 Tingling Fingers or Hands Item Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have tingling fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Primary	Area Under the Curve (AUC) EORTC CIPN20 Tingling Toes or Feet Item Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have tingling toes or feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Primary	Area Under the Curve (AUC) EORTC CIPN20 Numbness Fingers or Hands Item Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have numbness in your fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Primary	Area Under the Curve (AUC) EORTC CIPN20 Numbness Toes or Feet Item Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have numbness in your toes or feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Primary	Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Fingers or Hands Item Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have shooting or burning pain in your fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Primary	Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Toes or Feet Item Adjusting for Baseline	Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have shooting or burning pain in your Toes or Feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.	Up to 12 weeks
Secondary	Area Under the Curve (AUC) Per Assessment (aAUCpa) of Worst Pain (Item 1 on the Daily Post-Paclitaxel Questionnaire)	Average Area Under the Curve (AUC) per assessment (aAUCpa) of worst pain (item 1 on the Daily Post-Paclitaxel Questionnaire; "Please rate any aches/pain that are new since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment, by circling ONE number that best describes your aches/pain at its WORST in the last 24 hours.") over 1 week. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from day 2 through 7 following paclitaxel.	1 week