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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment rate (%) — Week 0
  Number of included patients / number of eligible patients within the study period
• Characteristics of included participants — Week 0
  Sex, age, cancer stage, comorbidities (cardiovascular, musculoskeletal, pulmonary, neurological, other).
• Attendance rate for MIET sessions (%) — Week 10-20
  Number of attended sessions / total number of planned sessions
• Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) — 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 — 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 (%) — Week 17-22
  Number of attended sessions / total number of planned sessions
• Adherence rate, ExRDI HIIT training (%) — 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 (%) — 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 (%) — 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'(%) — 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 (%) — 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 — Weeks 15, 20 and 22
  Reasons for not achieving the nutritional requirement as intended
• Drop-out rate (%) — Week 1-22
  Number of participants who dropped out divided by the total number of participants
• Time point of drop-out — Week 1-22
  Time point in the study (week number after inclusion) during which patients drop-out
• Reasons for drop-out — Week 1-22
  Reasons for drop-out
• Serious adverse events (SAE) — 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 — 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 — 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 — 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 — 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?

Trial sites (1)

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