Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients with Breastcancer (APRIORI)

February 18, 2025 updated by: Maastricht University Medical Center

FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients with Breast Cancer ReceivIng Neoadjuvant Chemotherapy

The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: Breast cancer is the most common type of cancer among women. The disease and treatment are associated with an increased risk of deterioration in physical fitness, muscle strength, nutritional status (sarcopenic obesity), mental well-being, health-related quality of life (HRQoL) and fatigue. To improve health outcomes, modifiable factors should be intervened as early as possible. The preoperative period during which patients receive neoadjuvant chemotherapy seems ideal to offer a multimodal lifestyle intervention, but is currently hardly used for this purpose. Nutritional status can be optimised through guidance from a dietician and self-monitoring of nutritional intake via a digital food diary. Additionally, offering a moderate-intensity endurance training (MIET) exercise programme during neoadjuvant intravenous chemotherapy infusion enables supervised exercise at a time when patients would otherwise be inactive. It may also improve tumour perfusion, thereby increasing the effectiveness of cytostatic uptake into the tumour and counteracting resistance to cytostatic drugs. The last six weeks prior to surgery can be used to further optimise cardiorespiratory fitness and muscle strength through a high-intensity interval training (HIIT) and strength training programme. Before the effect of a preoperative, multimodal lifestyle intervention in breast cancer patients receiving neoadjuvant chemotherapy can be investigated, its feasibility needs to be investigated first.

Objective: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.

Study design: A prospective, single-centre, longitudinal mixed-methods feasibility study.

Study population: Patients with breast cancer scheduled for neoadjuvant chemotherapy and surgery at the MUMC+ Comprehensive Cancer Center.

Intervention: The multimodal lifestyle intervention consists of three modalities. Patients are asked to complete 11 sessions of MIET during intravenous chemotherapy infusion, 8 sessions of HIIT and strength training in the last six weeks prior to surgery, and 4 consultations with a dietician throughout the preoperative period. The MIET training sessions consist of 45-50 minutes training programme on a cycle ergometer during the chemotherapy infusion. The physiotherapist will additionally advise patients to adhere (or build up to) the Nederlandse Norm Gezond Bewegen (NNGB) on remaining weekdays. The HIIT and strength training sessions consist of a 25 minutes training programme performed on a cycle ergometer, followed by four muscle-strengthening exercises. During the consultations with the dietician, patients' energy and protein intake are evaluated and advice is given on how to achieve the calculated energy and protein requirements. To improve patient self-management and empowerment, patients are also advised to use a free digital food diary.

Main study parameters/endpoints: The primary endpoint of the study is the feasibility of the multimodal lifestyle intervention with respect to recruitment, adherence, drop-out, safety and acceptance.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks of participating in the multimodal lifestyle intervention are considered minimal. The performance tests (Steep Ramp Test, 1-Repetition Maximum) are safe and feasible for this population. However, patients could experience some discomfort (exhaustion, muscle fatigue) due to the performance tests or exercise programs. Study related adverse events, related to exercise or nutritional changes, will be closely monitored and managed by the physiotherapist and dietician. Participation in study will take approximately 17.5 to 20 hours per patient. This time includes two consults with a physiotherapist, 8 sessions of HIIT and strength training, 4 consultations with a dietician, filling in the digital food diary and one semi-structured interview with the researcher to investigate acceptance of the multimodal lifestyle intervention and study procedures as perceived by patients. Patients are asked to complete questionnaires on fatigue and nutritional status on five different occasions.

Study Type

Interventional

Enrollment (Estimated)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
        • Contact:
        • Contact:
          • Hanneke C. van Dijk - Huisman, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with stage I-III breast cancer eligible for neoadjuvant intravenous chemotherapy at the MUMC+
  • Aged ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Scale grade 0-1 (Table 1)
  • Enough understanding of the Dutch language

Exclusion Criteria:

  • Human Epidermal growth factor Receptor 2 (HER2) - positive tumour
  • Scalp cooling
  • Conditions that seriously hamper physical exercise
  • Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multimodal lifestyle intervention

A group receiving a multimodal prehabilitation programme consisting of three modalities:

  1. MIET during neoadjuvant intravenous chemotherapy infusion
  2. HITT and strength training during the last six weeks prior to surgery
  3. Optimising nutritional intake throughout the total preoperative period
Behavioral: A multimodal prehabilitation programme

  1. During the weekly chemotherapy infusion (week 10-20), a supervised moderate-intensity endurance training (MIET) on a cycle ergometer is performed (11x):

    • 5 min. warm-up
    • 35 min. cycling at 40-60% of (HR reserve + resting HR)
    • 5-10 min. cool-down
  2. + strength training

During week 17-22 a supervised high-intensity interval training + strength training programme is performed (8x):

HITT:

  • 3 min warm-up (20W)
  • 14 intervals (30sec. work intervals at 60% of WRpeak alternates with 60-sec. rest intervals at 20W) --1 min. cool-down

Muscle strength:

4 exercises (leg press, chest press, abdominal crunch, lateral pulldown), 3 sets, 8-12 repetitions at 60% of 1-RM.

3) During 4 consultations with a dietician (week 9, 15, 20, 22) nutritional intake is evaluated and advice is given on energy and protein requirements. Patients are advised to use a digital food diary to record their intake for ≥3 days a week.

Other Names:
  • Not appliccable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate (%)
Time Frame: Week 0
Number of included patients / number of eligible patients within the study period
Week 0
Characteristics of included participants
Time Frame: Week 0
Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).
Week 0
Attendance rate for MIET sessions (%)
Time Frame: Week 10-20
Number of attended sessions / total number of planned sessions
Week 10-20
Adherence rate, exercise relative dose intensity (ExRDI) MIET (%)
Time Frame: Week 10-20

ExRDI = completed exercise dose intensity / prescribed exercise dose intensity.

Completed exercise dose intensity is defined as total duration (min.) performed in targeted HR zones * total training duration (min.) performed.

Prescribed exercise dose intensity is defined as total duration (min) prescribed in targeted HR zones * prescribed training duration.

ExRDI MIET = calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.
Week 10-20
Reasons for not having executed a training session as intended
Time Frame: Week 10-20
Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.)
Week 10-20
Attendance rate HIIT + strength sessions (%)
Time Frame: Week 17-22
Number of attended sessions / total number of planned sessions
Week 17-22
Adherence rate, ExRDI HIIT training (%)
Time Frame: Week 17-22

ExRDI = completed exercise dose intensity / prescribed exercise dose intensity.

Completed exercise dose intensity is defined as total duration (min) work intervals * completed work rate (W) work interval.

Prescribed exercise dose intensity is defined as prescribed total duration (min) work intervals * prescribed work rate (W) work interval.

ExRDI HIIT is calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants.
Week 17-22
Adherence rate, ErXDI strength training (%)
Time Frame: Week 17-22

ExRDI = completed exercise dose intensity / prescribed exercise dose intensity.

Completed exercise dose intensity is defined as completed training volume (weight * sets * repetitions)

Prescribed exercise dose intensity is defined as prescribed training volume (weight * sets * repetitions)

ExRDI strength training is calculated per participant per training session for each exercise and for all four exercises cumulative. And cumulative for all training sessions; and cumulative for all participants.
Week 17-22
Attendance rate for dietary consultations (%)
Time Frame: Weeks 9, 15, 20 and 22
Number of attended sessions / total number of planned sessions
Weeks 9, 15, 20 and 22
Percentage of use of the digital food diary 'Mijn Eetmeter'(%)
Time Frame: Weeks 15, 20 and 22
Number of days the food diary is filled out / total number of days agreed to complete
Weeks 15, 20 and 22
Percentage of days on which nutritional requirements were achieved (%)
Time Frame: Weeks 15, 20 and 22
Number of days on which individual nutritional recommendations (energy and protein intake) were achieved / number of days on which 'Mijn Eetmeter' is filled out
Weeks 15, 20 and 22
Reasons for not achieving the nutritional requirements as intended
Time Frame: Weeks 15, 20 and 22
Reasons for not achieving the nutritional requirement as intended
Weeks 15, 20 and 22
Drop-out rate (%)
Time Frame: Week 1-22
Number of participants who dropped out divided by the total number of participants
Week 1-22
Time point of drop-out
Time Frame: Week 1-22
Time point in the study (week number after inclusion) during which patients drop-out
Week 1-22
Reasons for drop-out
Time Frame: Week 1-22
Reasons for drop-out
Week 1-22
Serious adverse events (SAE)
Time Frame: Week 10-22

Any untoward medical occurrence or effect that:

  • results in death;
  • is life threatening (at the time of the event);
  • requires hospitalisation or prolongation of existing inpatients' hospitalisation;
  • results in persistent or significant disability or incapacity;
  • is a congenital anomaly or birth defect; or
  • any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator. An elective hospital admission will not be considered as a serious adverse event.
Week 10-22
Study related adverse events
Time Frame: Week 10-22

Any occurrence of the following study related adverse events during or immediately after a MIET or HITT and strength training session:

  • Early termination of the training, because of the occurrence of one of the subjective or objective termination criteria (as described in section 5.1)
  • extravasation (unintentional leakage of the chemotherapy agent from the vein into the surrounding tissue
  • collapse
  • severe muscle pain lasting >2 days
  • dizziness
  • severe nausea
  • excessive sweating
  • palpitations or chest pain during exertion
Week 10-22
Acceptance - Experiences with the multimodal lifestyle intervention
Time Frame: Week 22

Experiences with the multimodal lifestyle intervention as perceived by patients. Experiences are explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+.

Topic guide:

  • What was your experience with the multimodal lifestyle intervention in general?
  • What was your experience with the Moderate-intensity endurance training (MIET) during intravenous chemotherapy infusion?
  • What was your experience with the High-intensity interval training (HIIT) and strength training
  • What was your experience with the nutritional counselling and use of the digital food diary 'Mijn Eetmeter'?
Week 22
Acceptance - Suitability of the multimodal lifestyle intervention and study procedures
Time Frame: Week 22

Suitability of the intervention and study procedures as perceived by patients Suitability is explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+.

Topic guide:

  • Did you consider the intervention to be suitable for patients with breast cancer receiving neoadjuvant chemotherapy?
  • Did you consider the study procedures to be suitable for patients with breast cancer receiving neoadjuvant chemotherapy?
Week 22
Acceptance - Barriers and enablers regarding participation in the study
Time Frame: Week 22

Barriers and enablers regarding participation in the study as perceived by patients.

Barriers and enablers are explored by the researcher through conducting a semi-structured interviews with every patient. Semi-structured, individual, in-depth interviews are conducted in Dutch . Interviews are aimed to last 30 minutes sand will be conducted in a private room at the Department of Physiotherapy of the MUMC+.

Topic guide:

  • Which factors have positively influenced participation in the intervention?
  • Which factors have negatively influenced participation in the intervention?
Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Week 0, 9, 17, 20, 22
Fatique as determined on the Multidimensional Fatigue Index (MFI-20)
Week 0, 9, 17, 20, 22
Cardiorespiratory fitness
Time Frame: Week 0, 9, 17, 20, 22
Peak Work Rate (WRpeak) (W/kg) as determined on the Modified Steep Ramp Test (SRT)
Week 0, 9, 17, 20, 22
Muscle strength
Time Frame: Week 0, 9, 17, 20, 22
1-repetition maximum (1-RM) (kg) as determined by the Indirect RM tests on the leg press, chest press, abdominal crunch and lateral pulldown strength equipment
Week 0, 9, 17, 20, 22
Nutritional status
Time Frame: Week 0, 9, 15, 20, 22

Nutritional status as determined by the Patient Generated Subjective Global Assessment (PG-SGA) short form. The PG-SGA short form results in a PG-SGA score between 0 and 36 with a higher score indicating a higher risk of malnutrition and a higher need to intervene regarding the nutritional status.

Scoring:

0-1 = no intervention needed at this time. Regular reassessment during treatment.

2-3 = education to patient and family by dietitian, nurse, or other healthcare provider with medication intervention as indicated by present symptoms (section 3) and laboratory tests if applicable.

4-8 = (multidisciplinary) nutritional intervention by dietitian necessary, in combination with nurse or physician as indicated by present symptoms.

≥9 = severe indication for improved symptom control and/or nutritional intervention.
Week 0, 9, 15, 20, 22
Weight (kg)
Time Frame: Week 9, 15, 20, 22
Weight measured in kg on a weighing scale
Week 9, 15, 20, 22
Height (cm)
Time Frame: Week 9
Height measured in centimeters on a stadometer
Week 9
Body Mass Index (BMI)
Time Frame: Week 9, 15, 20, 22
Weight / (height*height)
Week 9, 15, 20, 22
Energy and protein intake (absolute kcal and gr and gr/kg body weight per day)
Time Frame: Week 9, 15, 20, 22
Determined by self-reported nutritional intake using the 'Mijn Eetmeter' digital food diary on at least three days per week (two weekdays and 1 weekend day)
Week 9, 15, 20, 22
Energy requirements (kcal)
Time Frame: Week 9
Calculated using the WHO-formula in patients with a BMI ≤ 30 kg/m2, and using the Harris & Benedict formula in patients with a BMI > 30 kg/m2
Week 9
Protein requirements
Time Frame: Week 9
1.2 - 1.5 g protein/ kg body weight per day BMI < 20 kg/m2: calculation based on weight matching a BMI of 20 kg/m2 BMI 20 - 25 kg/m2: calculation based on actual weight BMI > 25 kg/m2: calculation based on fat free mass determined by the formula of Gallagher
Week 9
Circumference of upper arm and waist (cm)
Time Frame: Week 9, 15, 20, 22
Circumference of upper arm and waist (cm) measured in stance using a tape measure.
Week 9, 15, 20, 22

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy Relative Dose Intensity (RDI)
Time Frame: Week 22
RDI quantifies the total amount of chemotherapy drugs a patient receives relative to the planned or standard dose for a specific treatment regimen. It is calculated by dividing the total actual dose intensity (the total amount of drug received) by the total planned or standard dose intensity (the total intended or recommended amount of drug) * 100. This approach considers the cumulative impact of all chemotherapy sessions and provides a more accurate reflection of the patient's overall exposure to the chemotherapy drugs over the course of treatment.
Week 22
Treatment-related Side effects
Time Frame: Week 10-22

Treatment-related side-effects are monitored weekly by the physiotherapist throughout the study period though patient-report.

  • Nausea
  • Vomiting
  • Oral mucositis (painful mouth)
  • Diarrhea
  • Constipation
  • Fever
  • Neutropenic fever
  • Febrile neutropenia
  • Periferal Sensoric neuropathy
  • Handfoot syndrome
  • Fatique
  • Hair loss
Week 10-22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Nationaal Fonds tegen Kanker

Investigators

  • Principal Investigator: Hanneke Dijk - Huisman, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maastricht UMC+

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not intent to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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