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Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paxman Scalp Cooling Device | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxman Scalp Cooling Device | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Preservation | 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. | 28 to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort | Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable) | 1 to 84 days |
| Chemotherapy-Induced Alopecia Distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Mirabella, PhD, RN, CHPN | HonorHealth Research Institute - Bisgrove | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paxman Scalp Cooling Device | 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). Paxman Scalp Cooling Device: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paxman Scalp Cooling Device | 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). Paxman Scalp Cooling Device: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hair Preservation | 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. | Only five (n=5) patients were analyzed due four (n=4) patients' early discontinuation of treatment | Posted | Count of Participants | Participants | 28 to 84 days |
|
Adverse events were collected during and shortly after treatment with scalp cooling device, up to 30 hours of total device usage over an 84-day period.
Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paxman Scalp Cooling Device | 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). Paxman Scalp Cooling Device: 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment | A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Mirabella PhD, RN, CHPN | HonorHealth Research Institute | 833-354-6667 | clinicaltrials@honorhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | Mar 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2020 | Mar 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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
| 1 to 84 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Chemotherapy-Induced Alopecia Distress Scale (CADS) | The CADS is specifically designed to measure the emotional and psychological impact of hair loss resulting from chemotherapy treatment. It aims to capture the distress, anxiety, and emotional burden that patients may experience due to alopecia during cancer treatment (1=Not at all through 4=Very much). The CADS total score is calculated by summing responses for all items, ranging from 0 to 51. A higher total score indicates higher distress. Median Total Score was assessed. | Median | Standard Deviation | median score on a scale |
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| Secondary | Patient Comfort | Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable) | Only five (n=5) patients were analyzed due four (n=4) patients' early discontinuation of treatment | Posted | Count of Participants | Participants | 1 to 84 days |
|
|
|
| Secondary | Chemotherapy-Induced Alopecia Distress | 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 | Only seven (n=7) patients were analyzed due two (n=2) patients' inability to tolerate cold from device | Posted | Median | Standard Deviation | score on a scale | 1 to 84 days |
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| 0 |
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| uncomfortable |
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| very uncomfortable |
|