Trial Outcomes & Findings for Scalp Cooling to Prevent Chemo-induced Hair Loss (NCT NCT01986140)

NCT ID: NCT01986140

Last Updated: 2021-07-27

Results Overview

The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.

• Recruitment status: UNKNOWN
• Study phase: NA
• Target enrollment: 236 participants
• Primary outcome timeframe: 4 to 8 Months
• Results posted on: 2021-07-27

Participant Flow

Participant milestones

Measure	PAXMAN Orbis Scalp Cooler Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Control No Treatment Control Control No treatment: No treatment to prevent hair loss
Overall Study STARTED	157	79
Overall Study COMPLETED	122	51
Overall Study NOT COMPLETED	35	28

Reasons for withdrawal

Measure	PAXMAN Orbis Scalp Cooler Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Control No Treatment Control Control No treatment: No treatment to prevent hair loss
Overall Study Withdrawal by Subject	31	25
Overall Study alternative treatment	1	1
Overall Study found not eligible	3	0
Overall Study Adverse Event	0	1
Overall Study progression disease	0	1

Baseline Characteristics

Scalp Cooling to Prevent Chemo-induced Hair Loss

Baseline characteristics by cohort

Measure	Scalp Cooling n=157 Participants Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Non-cooling n=79 Participants Control Control No treatment: No treatment to prevent hair loss	Total n=236 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 10.1 • n=5 Participants	50.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	50.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	157 Participants n=5 Participants	79 Participants n=7 Participants	236 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants	66 Participants n=7 Participants	196 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	62 Participants n=7 Participants	192 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	79 participants n=7 Participants	236 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 to 8 Months

Population: Randomized patients who underwent at least one cycle of chemotherapy were evaluable for efficacy. 27 patients in the cooling group and 25 patients in the non-cooling group did not start chemotherapy or discontinued during the 1st cycle were excluded from the efficacy analysis.

The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade <2, and will be assessed by a healthcare professional who is blinded to study treatment.

Outcome measures

Measure	Scalp Cooling n=130 Participants Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Non-cooling n=54 Participants Control Control No treatment: No treatment to prevent hair loss
Hair Preservation success	69 Participants	0 Participants
Hair Preservation failure	61 Participants	54 Participants

SECONDARY outcome

Timeframe: 5 years

A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 to 8 Months

Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression.

Outcome measures

Outcome data not reported

Adverse Events

Scalp Cooling

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Non-cooling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Scalp Cooling n=137 participants at risk Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Non-cooling Control Control No Treatment: No treatment to prevent hair loss
Ear and labyrinth disorders Ear pain	0.73% 1/137 • Number of events 1 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Gastrointestinal disorders nausea	5.1% 7/137 • Number of events 11 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
General disorders chills	0.73% 1/137 • Number of events 1 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
General disorders pain	0.73% 1/137 • Number of events 1 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Nervous system disorders dizziness	4.4% 6/137 • Number of events 7 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Nervous system disorders headache	19.7% 27/137 • Number of events 34 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Nervous system disorders paresthesia	0.73% 1/137 • Number of events 1 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Nervous system disorders Sinus pain	0.73% 1/137 • Number of events 1 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Skin and subcutaneous tissue disorders Dry skin	2.2% 3/137 • Number of events 3 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Skin and subcutaneous tissue disorders Pruritus	1.5% 2/137 • Number of events 2 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Skin and subcutaneous tissue disorders skin ulceration	0.73% 1/137 • Number of events 1 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Skin and subcutaneous tissue disorders scalp pain	4.4% 6/137 • Number of events 7 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.	— 0/0 • Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected. Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.

Additional Information

Tao Wang

Baylor College of Medicine

Phone: 7137985388

Email: taow@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place