Trial Outcomes & Findings for Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer (NCT NCT00751101)
NCT ID: NCT00751101
Last Updated: 2020-10-05
Results Overview
Incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 for all patients assigned who received at least 1 cycle of capecitabine.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2020-10-05
Participant Flow
Participant milestones
| Measure |
Arm A: Prior to Initiation of Capecitabine
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome (HFS) Symptoms Appear
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
Started Capecitabine
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Arm A: Prior to Initiation of Capecitabine
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome (HFS) Symptoms Appear
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
No HFS / Never Started Patch/
|
0
|
4
|
|
Overall Study
Never began capecitabine
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=12 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=12 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39 years old
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
80-89 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksIncidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 for all patients assigned who received at least 1 cycle of capecitabine.
Outcome measures
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=11 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=11 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
Grade 1 HFS
|
5 Participants
|
1 Participants
|
|
Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
Grade 2 HFS
|
5 Participants
|
6 Participants
|
|
Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
Grade 3 HFS
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 15 weeksBeginning from first capecitabine cycle following first use of nicotine patch up through final study visit after approximately 15 weeks of nicotine patch use. All toxicities will be graded and classified according to NCI CTCAE version 3.0.
Outcome measures
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=10 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=7 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Nausea
|
4 Participants
|
5 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Diarrhea
|
2 Participants
|
2 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 2 Diarrhea
|
1 Participants
|
0 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Headache
|
2 Participants
|
2 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 3 Headache
|
0 Participants
|
1 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Dizziness
|
1 Participants
|
2 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 2 Dizziness
|
1 Participants
|
0 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Sleep Disturbance
|
1 Participants
|
2 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 2 Sleep Disturbance
|
1 Participants
|
0 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Rash (at patch site)
|
2 Participants
|
2 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Constipation
|
0 Participants
|
1 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Stomach Pain
|
0 Participants
|
1 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Irritability
|
1 Participants
|
1 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Myalgia
|
2 Participants
|
1 Participants
|
|
Frequency of Side Effects of the Transdermal Nicotine Patch
Grade 1 Taste alteration
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 15 weeksPopulation: Only 2 patients returned the self-reported medication diaries
Self-report diaries of patch use beginning from capecitabine cycle following first use of nicotine patch use up through 15 weeks of possible nicotine patch use. Compliance will be reported by category (Compliant, Not Compliant, No Diaries Returned)
Outcome measures
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=11 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=11 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
Compliant
|
1 participants
|
1 participants
|
|
Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
Not Compliant
|
0 participants
|
0 participants
|
|
Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
No Diaries Returned
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: No toxicities for dose reduction assessed at cycle 1. The maximum number of cycles where a dose reduction occurred was 8 for Arm A, and 5 for Arm B.
Determined by the number of patients who required a toxicity-related, dose reduction of capecitabine during active treatment at each cycle where a dose reduction occurred.
Outcome measures
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=11 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=11 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 3
|
3 Participants
|
5 Participants
|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 2
|
3 Participants
|
4 Participants
|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 4
|
0 Participants
|
1 Participants
|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 5
|
1 Participants
|
1 Participants
|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 6
|
0 Participants
|
NA Participants
Maximum number of cycles where a dose reduction occurred was 5 for Arm B.
|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 7
|
1 Participants
|
NA Participants
Maximum number of cycles where a dose reduction occurred was 5 for Arm B.
|
|
Number of Patients Requiring Dose Reduction of Capecitabine
Treatment Cycle 8
|
1 Participants
|
NA Participants
Maximum number of cycles where a dose reduction occurred was 5 for Arm B.
|
SECONDARY outcome
Timeframe: Until last dose of capecitabine treatment or HFS has resolved, approximately 1 yearDetermine the number of patients requiring pain medication for the management of symptomatic HFS
Outcome measures
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=10 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=7 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Patients With Reported Use of Pain Medication for HFS
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Until last dose of capecitabine treatment or HFS has resolved, approximately 1 yearDetermine the number of patients utilizing additional treatments for symptomatic HFS. Additional treatments may include moisturizers, ice, and/or cooling packs
Outcome measures
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=10 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=7 Participants
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Patients With Reported Use of Other Symptomatic Treatments for HFS
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 15 weeksPopulation: Data for this endpoint was not collected
The Functional Assessment of Cancer Therapy - Breast (FACT-B) scale is widely used to measure health-related quality of life in cancer patients. The FACT-B is a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer, given at screening, week 9, and week 15 assessments during nicotine patch use.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Prior to Initiation of Capecitabine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm B: After Hand-foot Syndrome Symptoms Appear
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Prior to Initiation of Capecitabine
n=11 participants at risk
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
Arm B: After Hand-foot Syndrome Symptoms Appear
n=11 participants at risk
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
72.7%
8/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
72.7%
8/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
36.4%
4/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Nervous system disorders
Sleep Disturbance
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Injury, poisoning and procedural complications
Rash (at patch site)
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
General disorders
Irritability
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Gastrointestinal disorders
Taste alteration
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
18.2%
2/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
|
Gastrointestinal disorders
Oral ulcerations
|
0.00%
0/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
9.1%
1/11 • Up to 30 days after patient's last dose of capecitabine, approximately 1 year
|
Additional Information
Dr. Hope Rugo, MD
University of California, San Francisco
Phone: (415) 353-7618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place