NCT00751101

Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer

Terminated Phase 2 Results posted Last updated 5 October 2020

What this trial tests

Phase 2 trial testing Nicotine patch in Breast Cancer in 24 participants. Terminated before completion.

Timeline

20 August 2007

Primary endpoint
24 March 2014

24 March 2018

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	24
Start date	20 August 2007
Primary completion	24 March 2014
Estimated completion	24 March 2018
Sites	1 location across United States

Drugs / interventions tested

• Nicotine patch (nicotine-patch) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Chemotherapeutic Agent Toxicity — all drugs for Chemotherapeutic Agent Toxicity →
• Palmar-plantar Erythrodysesthesia — all drugs for Palmar-plantar Erythrodysesthesia →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 75, any sex, with Breast Cancer or Chemotherapeutic Agent Toxicity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade Primary · up to 24 weeks

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.

Grade 1 HFS

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	5
Arm B: After Hand-foot Syndrome Symptoms Appear	1

Grade 2 HFS

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	5
Arm B: After Hand-foot Syndrome Symptoms Appear	6

Grade 3 HFS

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	0
Arm B: After Hand-foot Syndrome Symptoms Appear	1

Frequency of Side Effects of the Transdermal Nicotine Patch Secondary · Up to 15 weeks

Beginning 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.

Grade 1 Nausea

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	4
Arm B: After Hand-foot Syndrome Symptoms Appear	5

Grade 1 Diarrhea

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	2
Arm B: After Hand-foot Syndrome Symptoms Appear	2

Grade 2 Diarrhea

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	0

Grade 1 Headache

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	2
Arm B: After Hand-foot Syndrome Symptoms Appear	2

Grade 3 Headache

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	0
Arm B: After Hand-foot Syndrome Symptoms Appear	1

Grade 1 Dizziness

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	2

Grade 2 Dizziness

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	0

Grade 1 Sleep Disturbance

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	2

Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary Secondary · up to 15 weeks

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)

Compliant

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	1

Not Compliant

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	0
Arm B: After Hand-foot Syndrome Symptoms Appear	0

No Diaries Returned

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	10
Arm B: After Hand-foot Syndrome Symptoms Appear	10

Number of Patients Requiring Dose Reduction of Capecitabine Secondary · up to 24 weeks

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.

Treatment Cycle 2

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	3
Arm B: After Hand-foot Syndrome Symptoms Appear	4

Treatment Cycle 3

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	3
Arm B: After Hand-foot Syndrome Symptoms Appear	5

Treatment Cycle 4

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	0
Arm B: After Hand-foot Syndrome Symptoms Appear	1

Treatment Cycle 5

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	1

Treatment Cycle 6

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	0
Arm B: After Hand-foot Syndrome Symptoms Appear	NA

Treatment Cycle 7

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	NA

Treatment Cycle 8

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	1
Arm B: After Hand-foot Syndrome Symptoms Appear	NA

Number of Patients With Reported Use of Pain Medication for HFS Secondary · Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year

Determine the number of patients requiring pain medication for the management of symptomatic HFS

Group	Value	95% CI
Arm A	6
Arm B	7

Number of Patients With Reported Use of Other Symptomatic Treatments for HFS Secondary · Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year

Determine the number of patients utilizing additional treatments for symptomatic HFS. Additional treatments may include moisturizers, ice, and/or cooling packs

Group	Value	95% CI
Arm A: Prior to Initiation of Capecitabine	5
Arm B: After Hand-foot Syndrome Symptoms Appear	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 30 days after patient's last dose of capecitabine, approximately 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Prior to Initiation of Capecitabine

Serious: 0/11 (0%)

Deaths: 0/11

Arm B: After Hand-foot Syndrome Symptoms Appear

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (13 terms — click to expand)

Reaction	System	Arm A: Prior to Initiation…	Arm B: After Hand-foot Syn…
Nausea	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Sleep Disturbance	Nervous system disorders	—	—
Rash (at patch site)	Injury, poisoning and procedural complications	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Mucositis	Gastrointestinal disorders	—	—
Irritability	General disorders	—	—
Taste alteration	Gastrointestinal disorders	—	—
Stomach Pain	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Oral ulcerations	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT00751101 adverse events section.

Sponsor's own description

RATIONALE: Nicotine patches may reduce hand-foot syndrome in patients receiving capecitabine for metastatic breast cancer. It is not yet known which nicotine patch regimen may be more effective in reducing hand-foot syndrome.

PURPOSE: This randomized clinical trial is studying which schedule of using nicotine patches is more effective in reducing hand-foot syndrome in patients who are receiving capecitabine for metastatic breast cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.