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…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the feasibility of the multimodal
lifestyle intervention with respect to recruitment, adherence, drop-out, safety
and acceptance.
Secondary outcome
Secondary outcome parameters are Fatigue (Multidimensional Fatigue Index,
MFI-20), cardiorespiratory fitness (WRpeak on modified Steep Ramp Test), Muscle
Strength (1-Repetition Maximum on leg press, chest press, abdominal crunch and
lateral pulldown strength equipment), and nutritional status (Patient Generated
Subjective Global Assessment (PG-SGA) short form, weight (kg), height (cm),
energy and protein intake, energy and protein requirements, circumference of
upper arm and waist).
Background summary
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, mental well-being, and
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. During the preoperative period, 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.
Study 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.
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 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.
Study burden and risks
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 and
healthcare professionals. Patients are asked to complete questionnaires on
fatigue and nutritional status on five different occasions.
P. Debeyelaan 25
Maastricht 6229 HX
NL
P. Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
• Patients diagnosed with stage I-III breast cancer eligible for neoadjuvant
intravenous chemotherapy at the Maastricht University Medical Center
• Aged >=18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
grade 0-1 (Table 1) [40,41]
• Enough understanding of the Dutch language
Exclusion criteria
Exclusion criteria:
• Human Epidermal growth factor Receptor 2 (HER2) - positive tumour
• Scalp cooling
• Recurrent breast cancer
• 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06266312 |
| CCMO | NL85719.068.23 |