Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer

NCT06266312 | Recruiting

• 1 other identifier: Maastricht UMC+
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

Prehabilitation; Multimodal lifestyle intervention; Preoperative period; Feasibility study; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (20)

• Recruitment rate (%)

  Number of included patients / number of eligible patients within the study period

  Week 0

• Characteristics of included participants

  Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).

  Week 0

• Attendance rate for MIET sessions (%)

  Number of attended sessions / total number of planned sessions

  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.

  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.)

  Week 10-20

• Attendance rate HIIT + strength sessions (%)

  Number of attended sessions / total number of planned sessions

  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.

  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.

  Week 17-22

• Attendance rate for dietary consultations (%)

  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'(%)

  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 (%)

  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

  Reasons for not achieving the nutritional requirement as intended

  Weeks 15, 20 and 22

• Drop-out rate (%)

  Number of participants who dropped out divided by the total number of participants

  Week 1-22

• Time point of drop-out

  Time point in the study (week number after inclusion) during which patients drop-out

  Week 1-22

• Reasons for drop-out

  Reasons for drop-out

  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.

  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

  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'?

  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?

  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?

  Week 22

Secondary Outcomes (11)

• Fatigue

  Week 0, 9, 17, 20, 22

• Cardiorespiratory fitness

  Week 0, 9, 17, 20, 22

• Muscle strength

  Week 0, 9, 17, 20, 22

• Nutritional status

  Week 0, 9, 15, 20, 22

• Weight (kg)

  Week 9, 15, 20, 22

Other Outcomes (2)

• Chemotherapy Relative Dose Intensity (RDI)

  Week 22

• Treatment-related Side effects

  Week 10-22

Study Arms (1)

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

Behavioral: A multimodal prehabilitation programme

Interventions

A multimodal prehabilitation programme BEHAVIORAL

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.

Also known as: Not appliccable

multimodal lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Nationaal Fonds tegen Kanker: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hanneke Dijk - Huisman, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanneke van Dijk - Huisman, PhD

CONTACT

+31 43 3877146; hanneke.huisman@mumc.nl

Anouk Weemaes, MSc

CONTACT

+31 43 3877146; anouk.weemaes@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 20, 2024
• Study Start: May 27, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)