Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Substance Related Disorders

Breast Neoplasms

Syndrome

Hand-Foot Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

20 healthy volunteers were included in the healthy control group

30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration

Advanced breast cancer patients with first-line medication

Capecitabine 150Mg Oral Tablet

Yunwei Wei, doctor

xin Wu

Yunwei Wei

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy.

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy

Study on Skin Microbiome of HFS

Study on Skin Microbiota of Hand Foot Syndrome

Sponsor GmbH

First Affiliated Hospital of Harbin Medical University

Breast Diseases

Skin Diseases

Participants must start their exercise between the hours of 5am and 10am.

Participants must start their exercise between the hours of 3pm and 8pm.

Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.

Exercise Timing Groups

Adriana M Coletta, PhD, MS, RD

Adriana M Coletta, PhD

The purpose of this study is to demonstrate the feasibility of assigning breast cancer survivors currently receiving chemotherapy to exercise at a specific time of day, e.g., morning or afternoon/evening, for a 4-week exercise intervention. Information gathered from this study will help inform a future, larger trial.

Study Aims:

1. Assess the feasibility of engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Assigning windows of time within the day to complete exercise (e.g. 5-10am exercise start time vs. 3-8pm exercise start time) will be feasible among this patient population.

1a. Determine the acceptability engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Engaging in exercise at an assigned time-of-day will be acceptable in this patient population.

2. To generate evidence on the magnitude of the effect sizes and outcome variability of physical function and human performance variables. Tests to be conducted at baseline and end of study to measure physical function and human performance variables include: Timed up and go test, 30-second chair stand, handgrip strength, cardiorespiratory fitness.

Participants will be randomized 1:1 to an exercise timing group (AM or PM), of which they will be required to complete their exercise during a specific time of day. Participants randomized to the AM group will be required to start their exercise between 5am and 10am for the duration of the 4-week intervention. Participants randomized to the PM group will be required to start their exercise between 3pm and 8pm.

At baseline and end of study assessments, participants will complete the following physical tests to evaluate physical function, strength, and cardiorespiratory fitness: timed up and go test, 30-second chair stand test, handgrip strength test, cardiorespiratory fitness test. These tests and assessments will be carried out with the Huntsman Cancer Institute (HCI) Wellness Center's Personal Optimism With Exercise Recovery (POWER) program. These tests will occur at the HCI Wellness Center gym. At the end of study assessments participants will also be asked to complete an exit survey, and two short questionnaires related to sleeping and eating habits.

Participants will complete two personalized resistance exercise training sessions supervised by a Cancer Exercise Specialist via the telehealth platform in the electronic medical record. These resistance training sessions are part of the POWER program. Participants will also be required to engage in weekly, moderate-intensity aerobic exercise, with the goal of completing 90 minutes of aerobic exercise per week. The type of aerobic exercise engaged in (e.g., walking, biking, hiking, etc), and location to complete the aerobic exercise (e.g., at home, local park, local gym, HCI Wellness Center gym, etc.) is the participant's choice. Participant's will be required to submit weekly aerobic exercise training logs.

Exercise Timing in Breast Cancer Patients

Feasibility of Manipulating Exercise Timing in Breast Cancer Survivors on Chemotherapy

The proportion of patients who complete at least 75% of their assigned workouts within the time-of-day window assigned throughout the four-week assessment period

Study acceptability will be measured as the proportion of patients who qualitatively report a positive response to at least half of exit survey themes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Skin Microbiome of HFS	NCT04132713	Microbiota	Capecitabine 15...	18 Years - 65 Years	First Affiliated Hospital of Harbin Medical University
Exercise Timing in Breast Cancer Patients	NCT05821244	Breast Cancer	Exercise Timing...	18 Years -	University of Utah
Exercise Timing in Breast Cancer Patients	NCT05821244	Breast Cancer	Exercise Timing...	18 Years -	University of Utah
Study on Skin Microbiome of HFS	NCT04132713	Microbiota	Capecitabine 15...	18 Years - 65 Years	First Affiliated Hospital of Harbin Medical University

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