Hair Loss Prevention Study for Pancreatic Cancer

HonorHealth Research Institute

Status: Completed

Conditions: Alopecia

Treatments: Device: Paxman Scalp Cooling Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04492800

HRI-ScalpCooling-001

Details and patient eligibility

About

Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.

Full description

Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp cooling device, at the end of three, 3 week cycles of chemotherapy.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent/assent for the trial
• >18 years of age on day of signing informed consent
• Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin

Exclusion criteria

• Grade 1 alopecia
• Existing history of scalp metastases or the presence of scalp metastases is suspected
• No history of previous cancers within the past 5 years
• CNS malignancies (either primary or metastatic)
• Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy
• Imminent bone marrow ablation chemotherapy
• Imminent skull radiation
• Previously received or scheduled to undergo skull irradiation
• Severe liver or renal disease from any etiology as patient may not be able to metabolize or clear the metabolites of the chemotherapeutic agent
• Skin cancers including melanoma, squamous cell carcinoma and Merkel cell carcinoma
• Small cell carcinoma of the lung
• Solid tumors that have a high likelihood for metastasis in transit
• Squamous cell carcinoma of the lung

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Paxman Scalp Cooling Device

Other group

Description:

Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).

Treatment:

Device: Paxman Scalp Cooling Device