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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-04

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy (CIPN)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Concomitant limb cryocompression and scalp cooling

Intervention Type DEVICE

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.

Cancer subjects

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.

Group Type EXPERIMENTAL

Concomitant limb cryocompression and scalp cooling

Intervention Type DEVICE

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.

Interventions

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Concomitant limb cryocompression and scalp cooling

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

Concomitant limb cryocompression and scalp cooling

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes