Alopecia
Conditions
Brief summary
Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.
Detailed 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.
Interventions
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).
Sponsors
HonorHealth Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Preservation | 28 to 84 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | 1 to 84 days | Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable) |
| Chemotherapy-Induced Alopecia Distress | 1 to 84 days | Identify chemotherapy-induced alopecia distress by utilizing the chemotherapy-induced alopecia distress scale (CADS) with score totals ranging from 17-68, with a higher score indicating distress |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Mirabella, PhD, RN, CHPN
HonorHealth Research Institute - Bisgrove
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 9.4 |
| Chemotherapy-Induced Alopecia Distress Scale (CADS) | 17 median score on a scale STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized African American | 0 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 9 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 6 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
None listed