N/A
N=42
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02640053 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Oct 2018
Primary outcome: Primary: Area Under the Curve (AUC) EORTC CIPN20 Sensory Neuropathy Subscale Adjusting for Baseline — -1.4; -4.4 Average(subscale value*assessment) — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryotherapy (Procedure); Paclitaxel (Drug); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Academic and Community Cancer Research United
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Sensory Neuropathy Subscale Adjusting for Baseline |
-1.4; -4.4 | 0.26 |
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Tingling Fingers or Hands Item Adjusting for Baseline |
0.0; -2.1 | 0.72 |
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Tingling Toes or Feet Item Adjusting for Baseline |
-1.7; -4.9 | 0.39 |
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Numbness Fingers or Hands Item Adjusting for Baseline |
-5.6; -4.9 | 0.32 |
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Numbness Toes or Feet Item Adjusting for Baseline |
0.0; -3.2 | 0.41 |
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Fingers or Hands Item Adjusting for Baseline |
0.0; 0.0 | 0.76 |
| PRIMARY Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Toes or Feet Item Adjusting for Baseline |
0.0; 0.0 | 0.62 |
| SECONDARY Area Under the Curve (AUC) Per Assessment (aAUCpa) of Worst Pain (Item 1 on the Daily Post-Paclitaxel Questionnaire) |
95.0; 96.0 | 0.67 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02640053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.