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

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Arm A: Prior to initiation of capecitabine (experimental) and Arm B: After hand-foot syndrome symptoms appear (experimental).

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.

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.

The registry classes the interventions as drug.

More on the Plan

OBJECTIVES: Primary * Determine the feasibility of using nicotine patches, in terms of side effects and the number of voluntary withdrawals from the study, in patients with metastatic breast cancer undergoing chemotherapy with capecitabine.

OUTLINE: This is a multicenter study.

Patients are randomized to 1 of 2 treatment arms.

Patients receive oral capecitabine twice daily on days 1-7 and 15-21.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of breast cancer. No concurrent hand-foot syndrome (HFS) due to other medications. Prior HFS due to other medications allowed provided that the symptoms have been completely resolved for ≥ 4 weeks prior to study entry. Hormone receptor status not specified. Menopausal status not specified.

The full record lists 29 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2007-08-20 with completion listed for 2014-03-24.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade (time frame: up to 24 weeks).

It also tracked 6 secondary outcomes, for example Frequency of Side Effects of the Transdermal Nicotine Patch, Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary, Number of Patients With Reported Use of Pain Medication for HFS, Number of Patients With Reported Use of Other Symptomatic Treatments for HFS and Quality of Life as Measured by FACT-B Scale.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 24 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.