Clinical trial · Interventional
Hair Loss Prevention Study for Pancreatic Cancer
A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling
NCT04492800CI-TRIAL-00112609completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paxman Scalp Cooling Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Paxman Scalp Cooling Device
- 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).
- interventionNames
- Device: Paxman Scalp Cooling Device
Primary outcomes (1)
- measure
- Hair Preservation
- timeFrame
- 28 to 84 days
- description
- Hair preservation was graded and defined based on severity of hair loss (alopecia) Grade 0 or 1 (lower grade) versus Grade 2 (higher grade) as defined by the CTCAE Version 5.0. Grade 0 to 1 is defined as Hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; Grade 2 or higher is Hair loss of \>=50% normal for that individual that is readily apparent to others.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Central Nervous System (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
References
Publications (0)
Data not yet available
No reference posted for this study.