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

NCT03248193 | Unknown

• 1 other identifier: 2017/00138
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

paclitaxel; neuropathy; hypothermia; cryocompression; alopecia

Outcome Measures

Primary Outcomes (2)

• 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

  From the start of assessment until study completion, an average of 1 year

• 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.

  From the start of assessment until study completion, an average of 1 year

Secondary Outcomes (2)

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

  From the start of assessment until study completion, an average of 2 years

• Difference in qualitative symptom scores before and at the end of taxane-based chemotherapy with limb cryocompression.

  From the start of assessment until study completion, an average of 2 years

Study Arms (2)

Healthy subjects

EXPERIMENTAL

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

Cancer subjects

EXPERIMENTAL

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

Interventions

Concomitant limb cryocompression and scalp cooling 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.

Healthy subjects

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital Singapore

Singapore, 119228, Singapore

RECRUITING

Related Publications (3)

• 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.

  PMID: 18346229 BACKGROUND

• 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.

  PMID: 28119855 BACKGROUND

• 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.

  PMID: 26360921 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Alopecia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical

Study Officials

• Raghav Sundar

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raghav Sundar

CONTACT

(65) 6779 5555; raghav_sundar@nuhs.edu.sg

Joline Lim

CONTACT

(65) 6779 5555; joline_sj_lim@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 14, 2017
• Study Start: August 4, 2017
• Primary Completion: August 31, 2019
• Study Completion: April 30, 2020
• Last Updated: August 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)