Movement and Health Beyond Care (MoviS)

Breast Cancer Survivors Clinical Trial

— MoviS  

Official title:

Movement and Health Beyond Care, MoviS: Nutrition and Exercise Educational Programs for Breast Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04818359
• Other study ID #: UniUrb_21/10.07.2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Urbino "Carlo Bo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MoviS is a randomized controlled trial on the effect of aerobic exercise training on quality of life (QoL) among breast cancer (BC) survivors. Patients randomized to the intervention arm will receive lifestyle recommendations (nutrition and exercise) and will undergo the MoviS Training program, whereas control arm patients will receive lifestyle recommendations. The MoviS Training program consists of 3 months, 3 times per week, aerobic exercise, which will be supervised both directly (2 days each week) and remotely (1 day each week). Exercise intensity (40% to 70% of heart rate reserve) and duration (20 to 60 mins) will be gradually increased throughout the training period. Both arms will receive counseling on psychological well-being. The primary outcome is the improvement of QoL. The secondary outcome is the improvement of the health-related parameters. Study variables will be sampled and compared between and within groups at the baseline, after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).

Description:

BACKGROUND BC is the most common invasive cancer in women and evidence has shown that exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial that aims to evaluate the potential health benefits of exercise and proper nutritional habits. Aim The present research study aims to assess the efficacy of aerobic exercise training on the QoL of high-risk BC survivors and the improvement of health-related factors. Methods BC patients (sample size n=172), age 30-70 years, non-metastatic, stage 0-III, non-physically active, 6-12 months post-surgery, and post chemo- or radio-therapy, with a high risk of recurrence defined by one or more of the following criteria: BMI ≥ 25, diagnosis of metabolic syndrome, increased level of blood testosterone and insulin will be randomly allocated to the interventional arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS Training consists of 3 months of aerobic exercise training (2 d/week of directly supervised and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min). Both arms will receive counseling on healthy lifestyle habits (nutrition and exercise) based on the World Cancer Research Fund (WCRF) 2018 guidelines through the DIANA-Web platform. All patients will also undergo psychological well-being counseling, which comprises evaluation for anxiety and depression. The primary outcome is the improvement of the QoL assessed by the European Organization for Research and Treatment of Cancer QoL (EORTC QLQ-C30) questionnaire. The secondary outcome is the improvement of health-related parameters such as: fatigue; anthropometric measurements and body composition; cardiac function indexes and heart rate variability; functional parameters (cardiorespiratory fitness, muscle flexibility and strength, coordination and posture variability, upper limb muscle viscoelastic characteristics); psychological well-being; metabolic, hormonal and inflammatory risk factors; gut microbiota; osteoporosis level; recurrences. Diet habits, physical activity level, pharmacological treatments and comorbidity will be recorded as confounding factors and covariates. The hypothesis is that supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence. Data will be collected at baseline and after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion criteria:

1. Diagnosis of BC (stage 0-II-III, without metastases or recurrences diagnosis at recruitment).

2. After surgery and chemotherapy and/or radiotherapy treatments.

3. Maximum 12 months from surgical treatment.

4. Minimum 6 months from the end of chemotherapy.

5. Risk of recurrence will be identified with meeting at least 1 of the following criteria: BMI at diagnosis = 25 kg/m2, testosterone = 0.4 ng/mL (for women); serum insulin = 25 µU/mL (170 pmol/L); metabolic syndrome (at least 3 of the following 5 factors): a. glycemia = 100 mg/dL (6.05 mmol/L); b. triglycerides =150 mg/dL (1.69 mmol L); c. HDL-C <50 mg/dL (1.29 mmol/L) (woman), <40 mg/dL (1.04 mmol/L) (man); d. waist circumference = 80 cm (woman), = 90 cm (man); e. blood pressure = 130/85 mmHg.

6. Non-physically active: subjects who were not regularly active (assessed by IPAQ) for at least 6 months.

Exclusion criteria:

1. Not suitable for non-competitive physical activity after the cardiological medical examination.

2. Disabling pneumological, cardiological, neurological, orthopedic comorbidities and mental illness that prevent the exercise performance.

3. Treatment with drugs that alter the heart rate response to exercise.

4. Treatment with antidepressant drugs.

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

Behavioral:
• MoviS Training
Patients will undergo a supervised exercise program consisting of 3 months of aerobic exercise training (2 d/week of directly supervised exercise and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min).

Locations

Country	Name	City	State
Italy	Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino	Urbino	PU
Italy	University of Urbino Carlo Bo	Urbino	PU

Sponsors (3)

Lead Sponsor	Collaborator
University of Urbino "Carlo Bo"	National Cancer Institute, Milan, Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diet habits	Change in dietary intake assessed by questionnaire (14-item Mediterranean diet adherence screener, MEDIET) through DIANAWeb platform. Higher levels (8-9, or >10 points in the 14-item score) indicates adherence to the Mediterranean diet.	Baseline - after 3, 6, 12, 24 months
Other	Physical activity level	Change in physical activity level assessed by the sensewear armband activity monitor and by the international physical activity questionnaire (IPAQ). The output of both assessments expressed in metabolic equivalents (METs)-min/week.	Baseline - after 3, 6, 12, 24 months
Primary	Quality of life assessed by questionnaire	Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores ranging from 0 to 100; higher scores indicate better quality of life.	Baseline - after 3, 6, 12, 24 months
Secondary	Fatigue	Change in fatigue perception assessed by brief fatigue inventory (BFI) questionnaire. The score of the questionnaire ranges from 0 to 90. A higher score means more severe fatigue.	Baseline - after 3, 6, 12, 24 months
Secondary	Anthropometry	Change body mass index (BMI) expressed as body mass (kg) / height2 (m2).	Baseline - after 3, 6, 12, 24 months
Secondary	Body composition	Change fat mass (%) assessed by bioelectrical impedance analysis.	Baseline - after 3, 6, 12, 24 months
Secondary	Cardiac function indexes	Change in the global longitudinal strain (%) assessed by echocardiography.	Baseline - after 3, 6, 12, 24 months
Secondary	Heart rate variability	Change in heart rate variability assessed by 24-Holter monitoring.	Baseline - after 3 months
Secondary	Cardiorespiratory fitness	Change in cardiorespiratory fitness assessed by estimated maximal oxygen uptake (mL/min/kg).	Baseline - after 3, 6, 12, 24 months
Secondary	Flexibility	Change in muscle flexibility assessed by sit & reach test (m).	Baseline - after 3, 6, 12, 24 months
Secondary	Muscular fitness	Change strength assessed by isometric hand grip strength test (kg).	Baseline - after 3, 6, 12, 24 months
Secondary	Proprioceptive recalibration	Change assessed by stabilometry (Mean Velocity) (mm2/sec2).	Baseline - after 6 months
Secondary	Posture balance	Change assessed by stabilometry (Romberg Quotient test-European variant) (% over or under 100).	Baseline - after 6 months
Secondary	Upper limb muscles viscoelastic characteristics	Change in the muscle properties of the pectoralis major, upper trapezius, and sternoclavicular mastoid muscle assessed by a hand-held myotonometer.	Baseline - after 3 months
Secondary	Psychological well-being	Change in mood profile assessed by Profile of Mood States (POMS) questionnaire. The POMS questionnaire gives a 5-point Likert scale; a higher score indicates increased negative mood.	Baseline - after 3, 6, 12, 24 months
Secondary	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index	Change in HOMA-IR Index calculated as HOMA-IR = (FPI × FPG)/22.5, where FPI is fasting plasma insulin concentration (mU/l) and FPG is fasting plasma glucose (mmol/L), or as HOMA-IR = (FPI × FPG)/405 if fasting plasma glucose is expressed in mg/dL.	Baseline - after 3, 6, 12, 24 months
Secondary	Insulin-like growth factor (IGF-1)	Change in IGF-1 assessed by blood samples (µg/L).	Baseline - after 3, 6, 12, 24 months
Secondary	C-reactive protein	Change in high sensitivity C-reactive protein assessed by blood samples (mg/L).	Baseline - after 3, 6, 12, 24 months
Secondary	Gut microbiota	Change in microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene.	Baseline - after 3, 6, 12, 24 months
Secondary	Osteoporosis level	Change in computerized bone mineralometry assessed by T-Score (Normal: +2.5> T-score> -1.0; Osteopenia: -1.0> T-score> -2.5; Osteoporosis: T-score <-2.5; Severe osteoporosis: T-score <-2.5 with one or more fragility fractures).	Baseline - after 12 and 24 months
Secondary	Recurrences	Recurrences free interval defined as time from registration to time of documented recurrent disease.	Baseline - after 3, 6, 12, 24 months