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

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ClinicalTrials.gov Identifier: NCT03248193
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy (CIPN) Device: Concomitant limb cryocompression and scalp cooling Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: 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.
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.


Experimental: 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.
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.





Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248193


Contacts
Contact: Raghav Sundar (65) 6779 5555 raghav_sundar@nuhs.edu.sg
Contact: Joline Lim (65) 6779 5555 joline_sj_lim@nuhs.edu.sg

Locations
Singapore
National University Hospital Singapore Recruiting
Singapore, Singapore, 119228
Contact: Raghav Sundar    +65 6779 5555    raghav_sundar@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Raghav Sundar National University Hospital, Singapore

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03248193     History of Changes
Other Study ID Numbers: 2017/00138
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National University Hospital, Singapore:
paclitaxel
neuropathy
hypothermia
cryocompression
alopecia

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Alopecia
Alopecia Areata
Neuromuscular Diseases
Nervous System Diseases
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action