Breast CancerAPRIORINCT06266312
Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer
A study testing A multimodal prehabilitation programme in people with Breast Cancer and Breast Neoplasms, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- A multimodal prehabilitation programme
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 May 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
Hanneke C. van Dijk - Huisman, Dr., (+31)433877146, hanneke.huisman@mumc.nl
Anouk T.R. Weemaes, Dr., (+31)433877146, anouk.weemaes@mumc.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- A multimodal prehabilitation programme
- Keywords
- Prehabilitation, Multimodal lifestyle intervention, Preoperative period, Feasibility study, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multimodal prehabilitation programmeBehavioural
Also called Not appliccable
- 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
- + 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| multimodal lifestyle intervention | Experimental | 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 Receives: Behavioral: A multimodal prehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (%)
Number of included patients / number of eligible patients within the study period
Measured: Week 0
Characteristics of included participants
Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).
Measured: Week 0
Attendance rate for MIET sessions (%)
Number of attended sessions / total number of planned sessions
Measured: Week 10-20
Adherence rate, exercise relative dose intensity (ExRDI) MIET (%)
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.
Measured: Week 10-20
Reasons for not having executed a training session as intended
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.)
Measured: Week 10-20
Attendance rate HIIT + strength sessions (%)
Number of attended sessions / total number of planned sessions
Measured: Week 17-22
Adherence rate, ExRDI HIIT training (%)
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.
Measured: Week 17-22
Adherence rate, ErXDI strength training (%)
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.
Measured: Week 17-22
Attendance rate for dietary consultations (%)
Number of attended sessions / total number of planned sessions
Measured: Weeks 9, 15, 20 and 22
Percentage of use of the digital food diary 'Mijn Eetmeter'(%)
Number of days the food diary is filled out / total number of days agreed to complete
Measured: Weeks 15, 20 and 22
Percentage of days on which nutritional requirements were achieved (%)
Number of days on which individual nutritional recommendations (energy and protein intake) were achieved / number of days on which 'Mijn Eetmeter' is filled out
Measured: Weeks 15, 20 and 22
Reasons for not achieving the nutritional requirements as intended
Reasons for not achieving the nutritional requirement as intended
Measured: Weeks 15, 20 and 22
Drop-out rate (%)
Number of participants who dropped out divided by the total number of participants
Measured: Week 1-22
Time point of drop-out
Time point in the study (week number after inclusion) during which patients drop-out
Measured: Week 1-22
Reasons for drop-out
Reasons for drop-out
Measured: Week 1-22
Serious adverse events (SAE)
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.
Measured: Week 10-22
Study related adverse events
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
Measured: Week 10-22
Acceptance - Experiences with the multimodal lifestyle intervention
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'?
Measured: Week 22
Acceptance - Suitability of the multimodal lifestyle intervention and study procedures
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?
Measured: Week 22
Acceptance - Barriers and enablers regarding participation in the study
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?
Measured: Week 22
Secondary outcomes (11)
Fatigue
Fatique as determined on the Multidimensional Fatigue Index (MFI-20)
Measured: Week 0, 9, 17, 20, 22
Cardiorespiratory fitness
Peak Work Rate (WRpeak) (W/kg) as determined on the Modified Steep Ramp Test (SRT)
Measured: Week 0, 9, 17, 20, 22
Muscle strength
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
Measured: Week 0, 9, 17, 20, 22
Nutritional status
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.
Measured: Week 0, 9, 15, 20, 22
Weight (kg)
Weight measured in kg on a weighing scale
Measured: Week 9, 15, 20, 22
Height (cm)
Height measured in centimeters on a stadometer
Measured: Week 9
Body Mass Index (BMI)
Weight / (height*height)
Measured: Week 9, 15, 20, 22
Energy and protein intake (absolute kcal and gr and gr/kg body weight per day)
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)
Measured: Week 9, 15, 20, 22
Energy requirements (kcal)
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
Measured: Week 9
Protein requirements
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
Measured: Week 9
Circumference of upper arm and waist (cm)
Circumference of upper arm and waist (cm) measured in stance using a tape measure.
Measured: Week 9, 15, 20, 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start27 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nationaal Fonds tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Hanneke Dijk - Huisman, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266312
- Sponsor's protocol ID
- Maastricht UMC+
- Acronym
- APRIORI
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not intent to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients With Breast Cancer ReceivIng Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06266312
- Acronym / sponsor ID
- APRIORI / Maastricht UMC+
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Prehabilitation, Multimodal lifestyle intervention, Preoperative period, Feasibility study, Neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Nationaal Fonds tegen Kanker
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed 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.
| Arm | Type | Receives |
|---|---|---|
| multimodal lifestyle intervention | Experimental | Behavioral: A multimodal prehabilitation programmeA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A multimodal prehabilitation programmeAlso: Not appliccable1. 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. | Behavioural | multimodal lifestyle intervention |
Primary outcome
Recruitment rate (%)
Time frame: Week 0
Number of included patients / number of eligible patients within the study period
Characteristics of included participants
Time frame: Week 0
Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).
Attendance rate for MIET sessions (%)
Time frame: Week 10-20
Number of attended sessions / total number of planned sessions
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.
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.)
Attendance rate HIIT + strength sessions (%)
Time frame: Week 17-22
Number of attended sessions / total number of planned sessions
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.
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.
Attendance rate for dietary consultations (%)
Time frame: Weeks 9, 15, 20 and 22
Number of attended sessions / total number of planned sessions
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
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
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
Drop-out rate (%)
Time frame: Week 1-22
Number of participants who dropped out divided by the total number of participants
Time point of drop-out
Time frame: Week 1-22
Time point in the study (week number after inclusion) during which patients drop-out
Reasons for drop-out
Time frame: Week 1-22
Reasons for drop-out
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.
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
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'?
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?
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?
11 secondary outcomes
Fatigue
Time frame: Week 0, 9, 17, 20, 22
Cardiorespiratory fitness
Time frame: Week 0, 9, 17, 20, 22
Muscle strength
Time frame: Week 0, 9, 17, 20, 22
Nutritional status
Time frame: Week 0, 9, 15, 20, 22
Weight (kg)
Time frame: Week 9, 15, 20, 22
Height (cm)
Time frame: Week 9
Body Mass Index (BMI)
Time frame: 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
Energy requirements (kcal)
Time frame: Week 9
Protein requirements
Time frame: Week 9
Circumference of upper arm and waist (cm)
Time frame: Week 9, 15, 20, 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. We do not intent to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanneke Dijk - Huisman, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multimodal prehabilitation programme in people with Breast Cancer and Breast Neoplasms, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanneke van Dijk - Huisman, PhD (+31 43 3877146 ext. +31 43 3877146, hanneke.huisman@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (%) (time frame: Week 0). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.