Clinical trial NCT06266312: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer
Official title: FeAsibility of a PReoperative, Multimodal Lifestyle InterventiOn in Patients With Breast Cancer ReceivIng Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Prehabilitation
Multimodal lifestyle intervention
Preoperative period
Feasibility study
Neoadjuvant chemotherapy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Nationaal Fonds tegen Kanker
First posted: 2024-02-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate (%)
timeFrame: Week 0
measure: Characteristics of included participants
timeFrame: Week 0
measure: Attendance rate for MIET sessions (%)
timeFrame: Week 10-20
measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%)
timeFrame: Week 10-20
measure: Reasons for not having executed a training session as intended
timeFrame: Week 10-20
measure: Attendance rate HIIT + strength sessions (%)
timeFrame: Week 17-22
measure: Adherence rate, ExRDI HIIT training (%)
timeFrame: Week 17-22
measure: Adherence rate, ErXDI strength training (%)
timeFrame: Week 17-22
measure: Attendance rate for dietary consultations (%)
timeFrame: Weeks 9, 15, 20 and 22
measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%)
timeFrame: Weeks 15, 20 and 22
measure: Percentage of days on which nutritional requirements were achieved (%)
timeFrame: Weeks 15, 20 and 22
measure: Reasons for not achieving the nutritional requirements as intended
timeFrame: Weeks 15, 20 and 22
measure: Drop-out rate (%)
timeFrame: Week 1-22
measure: Time point of drop-out
timeFrame: Week 1-22
measure: Reasons for drop-out
timeFrame: Week 1-22
measure: Serious adverse events (SAE)
timeFrame: Week 10-22
measure: Study related adverse events
timeFrame: Week 10-22
measure: Acceptance - Experiences with the multimodal lifestyle intervention
timeFrame: Week 22
measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures
timeFrame: Week 22
measure: Acceptance - Barriers and enablers regarding participation in the study
timeFrame: Week 22
Secondary outcomes:
measure: Fatigue
timeFrame: Week 0, 9, 17, 20, 22
measure: Cardiorespiratory fitness
timeFrame: Week 0, 9, 17, 20, 22
measure: Muscle strength
timeFrame: Week 0, 9, 17, 20, 22
measure: Nutritional status
timeFrame: Week 0, 9, 15, 20, 22
measure: Weight (kg)
timeFrame: Week 9, 15, 20, 22
measure: Height (cm)
timeFrame: Week 9
measure: Body Mass Index (BMI)
timeFrame: Week 9, 15, 20, 22
measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day)
timeFrame: Week 9, 15, 20, 22
measure: Energy requirements (kcal)
timeFrame: Week 9
measure: Protein requirements
timeFrame: Week 9
measure: Circumference of upper arm and waist (cm)
timeFrame: Week 9, 15, 20, 22
Other outcomes:
measure: Chemotherapy Relative Dose Intensity (RDI)
timeFrame: Week 22
measure: Treatment-related Side effects
timeFrame: Week 10-22
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Hanneke Dijk - Huisman, PhD
role: PRINCIPAL_INVESTIGATOR
References: