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

NCT03248193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-14

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy (CIPN)

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Raghav Sundar · National University Hospital, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2019-08-31
Completion
2020-04-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248193 on ClinicalTrials.gov