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Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Concomitant limb cryocompression and scalp cooling
Concomitant limb cryocompression and scalp cooling
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy (CIPN) focused on measuring paclitaxel, neuropathy, hypothermia, cryocompression, alopecia

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The inclusion criterion for the healthy subjects:

  • Age 21-80 years
  • Signed informed consent from patient.
  • No history of neuropathy
  • ECOG 0
  • No history of hospitalization in the past 6 months

The inclusion criteria for the cancer patients:

  • Age 21- 80 years.
  • Signed informed consent from patient
  • Scheduled to receive weekly paclitaxel chemotherapy

For both healthy subjects and cancer patients:

  • Open skin wound or ulcers of the limbs
  • A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (see outcome parameters) (Not applicable for healthy subjects)
  • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes

Sites / Locations

  • National University Hospital SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy subjects

Cancer subjects

Arm Description

To assess safety and tolerability of scalp and limb hypothermia, as well as to determine the optimal temperature and pressure to be used. Establishing the occurrence or lack of core hypothermia will be studied.

Once the optimal temperature and pressure of scalp and limb hypothermia is established in healthy patients, a group of cancer patients will undergo concomitant scalp and limb hypothermia over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.

Outcomes

Primary Outcome Measures

Investigation of safety and tolerability of concomitant scalp cooling and limb cryocompression in healthy subjects: defined as the number of patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales
Investigation of safety and tolerability of concomitant scalp cooling and limb cryocompression in cancer patients: defined as the number of patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales.

Secondary Outcome Measures

Difference in sensory nerve action potential on nerve conduction tests before and at the end of taxane-based chemotherapy with limb cryocompression.
Difference in qualitative symptom scores before and at the end of taxane-based chemotherapy with limb cryocompression.

Full Information

First Posted
August 1, 2017
Last Updated
August 9, 2017
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03248193
Brief Title
Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia
Official Title
Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Paclitaxel is a chemotherapy drug that is used to treat breast cancer, one of the most common cancers. It causes two side effects very often - hair-loss and numbness. Until recently, there have been no known ways to prevent or treat either side effect. Recently, cooling of the scalp to prevent hair loss caused by paclitaxel was approved. Our team is developing a method to prevent numbness caused by paclitaxel by using a device that cools the arms and the legs, while applying mild pressure, and this technique is called cryocompression. As scalp cooling use in day-to-day cancer care increases, future studies involving cryocompression to treat neuropathy must take this into account, lest patients be denied or are required to trade-off one treatment for the other. However, there is concern of causing a reduction in core body temperature, which would not be safe or a general intolerance to this treatment. Both scalp cooling and limb cryocompression individually have not shown to cause this, but simultaneous use has not been studied previously. Clinical safety studies, in healthy subjects and cancer patients would need to be conducted to prove this theory, which is being proposed by currently.
Detailed Description
Paclitaxel is a key chemotherapeutic agent used in the management of common cancers, such as breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) due to paclitaxel is a common dose-limiting toxicity with no effective prevention or treatment. Limb cryocompression is currently being developed as a method to reduce CIPN. Another common toxicity of paclitaxel is chemotherapy induced alopecia (CIA), for which scalp-cooling is currently an approved therapy to reduce the incidence of this adverse effect. As scalp cooling use in day-to-day clinical practice increases, future studies involving hypothermia to treat neuropathy must factor this into the treatment algorithm, lest patients be denied or are required to trade-off one treatment for the other. However, there is concern of causing core hypothermia and/or general intolerance to concomitant therapy. Both scalp-cooling and cryocompression individually have not shown to cause this, but simultaneous use has not been studied previously. Clinical safety studies, in healthy subjects and cancer patients would need to be conducted first, before larger efficacy studies are performed. We propose that we can deliver scalp-cooling and limb cryocompression with a single treatment modality to prevent two toxicities of paclitaxel - CIA and CIPN. This study will consist of two parts: A) Healthy subjects: To assess safety and tolerability of scalp and limb cryocompression, as well as to determine the optimal temperature and pressure to be used, that will contribute to the cryocompression protocol. The occurrence of core hypothermia or intolerance will be closely monitored B) Cancer patients: Once the optimal cryocompression protocol is established in healthy patients, a group of cancer patients will undergo concomitant limb cryocompression and scalp cooling over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Early clinical efficacy signal data will also be collected, to prepare for the subsequent larger randomized efficacy study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Keywords
paclitaxel, neuropathy, hypothermia, cryocompression, alopecia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This study will consist of two parts: A) Healthy subjects: To assess safety and tolerability of scalp and limb hypothermia, as well as to determine the optimal temperature and pressure to be used. Establishing the occurrence or lack of core hypothermia will be studied. B) Cancer patients: Once the optimal temperature and pressure of scalp and limb hypothermia is established in healthy patients, a group of cancer patients will undergo concomitant scalp and limb hypothermia over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
To assess safety and tolerability of scalp and limb hypothermia, as well as to determine the optimal temperature and pressure to be used. Establishing the occurrence or lack of core hypothermia will be studied.
Arm Title
Cancer subjects
Arm Type
Experimental
Arm Description
Once the optimal temperature and pressure of scalp and limb hypothermia is established in healthy patients, a group of cancer patients will undergo concomitant scalp and limb hypothermia over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.
Intervention Type
Device
Intervention Name(s)
Concomitant limb cryocompression and scalp cooling
Intervention Description
Part 1: Establishing optimal temperature for hypothermia therapy. Healthy subjects will undergo 3 hours of cryocompression various temperature levels. Part 2: Establishing optimal pressure for hypothermia therapy. Each subject will undergo cryocompression (fixed at the lowest tolerated temperature established in Section 1) over 3 hours. The pressure ranges to be tested are either low, medium, or high. Part 3: Establishing safety and tolerability of scalp hypothermia. Scalp hypothermia will be administered over 3 hours using the cooling cap attached to the cooling device. Part 4: Establishing safety and tolerability of concomitant therapy. Subjects will undergo simultaneous scalp hypothermia and four-limb cryocompression at the temperature and pressure established in Sections 1 and 2. The concomitant therapy will be administered over 3 hours.
Intervention Type
Device
Intervention Name(s)
Concomitant limb cryocompression and scalp cooling
Intervention Description
The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles. Paclitaxel will be administered as a one-hour infusion. Concomitant scalp cooling and limb cryocompression sessions comprised of a pre-cooling period (one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, hypothermia will be administered for no longer than four hours. Cryocompression will be administered on patients based on the lowest tolerated temperature and optimal pressure as determined in healthy subjects.
Primary Outcome Measure Information:
Title
Investigation of safety and tolerability of concomitant scalp cooling and limb cryocompression in healthy subjects: defined as the number of patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales
Time Frame
From the start of assessment until study completion, an average of 1 year
Title
Investigation of safety and tolerability of concomitant scalp cooling and limb cryocompression in cancer patients: defined as the number of patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales.
Time Frame
From the start of assessment until study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Difference in sensory nerve action potential on nerve conduction tests before and at the end of taxane-based chemotherapy with limb cryocompression.
Time Frame
From the start of assessment until study completion, an average of 2 years
Title
Difference in qualitative symptom scores before and at the end of taxane-based chemotherapy with limb cryocompression.
Time Frame
From the start of assessment until study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion criterion for the healthy subjects: Age 21-80 years Signed informed consent from patient. No history of neuropathy ECOG 0 No history of hospitalization in the past 6 months The inclusion criteria for the cancer patients: Age 21- 80 years. Signed informed consent from patient Scheduled to receive weekly paclitaxel chemotherapy For both healthy subjects and cancer patients: Open skin wound or ulcers of the limbs A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (see outcome parameters) (Not applicable for healthy subjects) History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raghav Sundar
Phone
(65) 6779 5555
Email
raghav_sundar@nuhs.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Joline Lim
Phone
(65) 6779 5555
Email
joline_sj_lim@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raghav Sundar
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghav Sundar
Phone
+65 6779 5555
Email
raghav_sundar@nuhs.edu.sg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18346229
Citation
Windebank AJ, Grisold W. Chemotherapy-induced neuropathy. J Peripher Nerv Syst. 2008 Mar;13(1):27-46. doi: 10.1111/j.1529-8027.2008.00156.x.
Results Reference
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PubMed Identifier
28119855
Citation
Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.
Results Reference
background
PubMed Identifier
26360921
Citation
Bandla A, Sundar R, Liao LD, Sze Hui Tan S, Lee SC, Thakor NV, Wilder-Smith EP. Hypothermia for preventing chemotherapy-induced neuropathy - a pilot study on safety and tolerability in healthy controls. Acta Oncol. 2016;55(4):430-6. doi: 10.3109/0284186X.2015.1075664. Epub 2015 Sep 11.
Results Reference
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Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia

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