Clinical trial NCT04818359: Movement and Health Beyond Care (MoviS)
Official title: Movement and Health Beyond Care, MoviS: Nutrition and Exercise Educational Programs for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Survivors
Keywords: Breast Cancer
Exercise
Quality of Life
Lead sponsor: University of Urbino "Carlo Bo"
Sponsor class: OTHER
Collaborators: name: Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino
name: National Cancer Institute, Milan
First posted: 2021-03-26
Enrollment: 172
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to undergo either a lifestyle recommendations and supervised exercise program or only lifestyle recommendations
Primary purpose: PREVENTION

Brief 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).

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life assessed by questionnaire
timeFrame: Baseline - after 3, 6, 12, 24 months
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Anthropometry
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Body composition
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Cardiac function indexes
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Heart rate variability
timeFrame: Baseline - after 3 months
measure: Cardiorespiratory fitness
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Flexibility
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Muscular fitness
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Proprioceptive recalibration
timeFrame: Baseline - after 6 months
measure: Posture balance
timeFrame: Baseline - after 6 months
measure: Upper limb muscles viscoelastic characteristics
timeFrame: Baseline - after 3 months
measure: Psychological well-being
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Insulin-like growth factor (IGF-1)
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: C-reactive protein
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Gut microbiota
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Osteoporosis level
timeFrame: Baseline - after 12 and 24 months
measure: Recurrences
timeFrame: Baseline - after 3, 6, 12, 24 months
Other outcomes:
measure: Diet habits
timeFrame: Baseline - after 3, 6, 12, 24 months
measure: Physical activity level
timeFrame: Baseline - after 3, 6, 12, 24 months
Locations:
city: Urbino
country: Italy
facility: Presidio Ospedaliero Unico "Santa Maria della Misericordia", Urbino
state: PU
city: Urbino
country: Italy
facility: University of Urbino Carlo Bo
state: PU
Study officials:
References: