PrehabilitationNEO STRONGNCT06309290
Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy
A study testing Prehabilitation with resistance-exercise training in people with Prehabilitation and Breast Cancer, run by Universidad de La Frontera at 2 sites in Chile.
Trial summary
Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prehabilitation, Breast Cancer, Postmenopause
- What is being tested?
- Prehabilitation with resistance-exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesChile
- Study dates
- 1 Jan 2025to Dec 2026
- Phase
- Interventional
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women with breast cancer in stages I, II and III with luminal breast tumor, HER2+ or TNBC
- Indication for neoadjuvant chemotherapy
- Candidates for curative breast surgery
- Body mass index: 18.5 <BMI <30 kg/m2
- Sedentary (does not perform scheduled or planned physical activity ≥ 2 times a week)
- Willingness to participate in the study and follow the proposed prehabilitation scheme.
Who cannot join
- Present comorbidities that interact with the metabolism and mobility of the muscles of the body and that do not allow the (safe) performance of strength exercises (e.g., debilitating arthritis, all neurological disorders, paralysis, among others).
- Severe or uncontrolled cardiovascular disease, cardiac ejection fraction less than 50%
- Previous antineoplastic treatment
- Use of nutritional supplements (leucine, glutamine, casein, whey protein, fatty acids and creatine).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites, 2 recruiting
- Recruiting
Fundación Arturo López Pérez
Santiago
Gabriel N Marzuca-Nassr, PT, MSc, PhD, +56 45 2596713, gabriel.marzuca@ufrontera.cl
- Recruiting
Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile
Temuco
Gabriel N Marzuca-Nassr, MSc, PhD
About this study
Official title: Prehabilitation Based on Resistance-exercise Training in Women With Breast Cancer Undergoing Neoadjuvant Therapy: From Molecular Mechanism to Clinical Benefits
Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown.
Read the detailed description
Hypothesis: Prehabilitation based on resistance-exercise training before surgery in women with breast cancer undergoing neoadjuvant therapy increases skeletal muscle mass compared with usual care.
Secondary, prehabilitation based on resistance-exercise training before surgery in women with breast cancer undergoing neoadjuvant therapy generates better results in body composition, physical performance, clinical parameters (serious adverse events, hospital readmission, infection, complications), physiological parameters and quality of life at one-month hospital discharge compared to usual care.
Objective: To determine the effects of prehabilitation based on resistance-exercise training versus usual care, before and after breast surgery, on skeletal muscle mass in women with breast cancer undergoing neoadjuvant chemotherapy.
Methodology: A single-blind, randomized controlled clinical trial will be developed. Sixty-eight postmenopausal women with stage I, II and III breast cancer with HER2+ type breast tumor and Triple negative breast cancer undergoing neoadjuvant therapy and with an indication for breast surgery will be divided into two groups: usual care (CONTROL, n=34) versus Prehabilitation (P-REHAB, n=34). All participants will receive an education session 20 weeks before surgery + neoadjuvant chemotherapy for 16-20 weeks as is normally done for this type of patien. Only participants in the P-REHAB group will undergo 16-20 weeks of whole-body resistance-exercise training (twice a week). At baseline, after prehabilitation program and 4 weeks after surgery, the cross-sectional area of the quadriceps muscle and of the muscle region at lumbar level 3 will be determined by CT-Scan. Also, fasting blood samples will be obtained to measure biochemical and molecular markers (e.g. miRNAs). Maximal strength will be determined by 1 repetition maximum (1RM) leg press, leg extension, lat pull down, chest press, horizontal row, and handgrip. In addition, physical performance will be assessed with the short physical performance battery (SPPB), functional capacity with the 6-minute walk test, quality of life with the BR23 questionnaire, and cancer-related fatigue with the Brief Fatigue Inventory scale at the same time points. Finally, samples from tumor breast cancer and pectoralis muscle will be obtained on the day of breast surgery.
Expected results: It is expected that prehabilitation based on resistance-exercise training results in increased muscle mass in women with breast cancer undergoing neoadjuvant chemotherapy compared to participants receiving usual care. Also, it is expected that this intervention before surgery in women with breast cancer undergoing neoadjuvant therapy will generate better results in clinical parameters (serious adverse events, hospital readmission, infection, complications) and quality of life one month after hospital discharge compared to usual care . These results will allow the creation of local, regional, national and international strategies to combat the adverse effects of breast cancer and its antineoplastic treatment, especially in women with more aggressive breast cancer.
- Conditions
- Prehabilitation, Breast Cancer, Postmenopause, Resistance Training
- Being tested
- Prehabilitation with resistance-exercise training, Usual care program
- Keywords
- Prehabilitation, Breast neoplasm, Strength Training, Skeletal muscle, Muscle strength
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation with resistance-exercise trainingOther
Also called Prolonged resistance-type exercise training, Prehabilitation
The volunteers in the intervention group will be subjected to 16 - 20 weeks of whole-body resistance-type exercise training (2x/wk).
Usual care programOther
Also called Standard therapy
The volunteers in the intervention group will be subjected to usual care (diagnosis confirmation, chemotherapy treatment planning and an initial education session).
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation intervention program | Experimental | All volunteers be subjected to 16 - 20 weeks of full body resistance exercise training (2 times per week. However, usual care program. Receives: Other: Prehabilitation with resistance-exercise training |
| Usual Care Program | Active comparator | All volunteers be subjected usual care (diagnosis confirmation, chemotherapy treatment planning and an initial education session). Receives: Other: Usual care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle mass (measured via Computed tomography (CT) scan)
Cross-sectional area of the quadriceps via single-slice CT scan
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Secondary outcomes (8)
Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing)
Maximal strength assessment via 1RM testing of horizontal row, lat pull down, chest press, leg press, and leg extension)
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Change in hand grip strength (measured via JAMAR handheld dynamometer)
Maximal strength assessment via 1RM testing of JAMAR handheld dynamometer.
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Change in physical performance measured via Short physical performance battery
Measurement of physical performance via SPPB Short physical performance battery (0 to 12 points, whether higher scores mean a better outcome).
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Measurement of quality of life via EORTC QLQ-30, this questionnaire has 30 question covering functional state and cancer related symptoms. Besides, there are two specific question covering the "overall health" and "overall quality of life". The scores obtained are standardized and a score between 0 and 100 is obtained. High values on the global health and functional status scales indicate a better quality of life. However, high values on the symptom scale indicate a lower quality of life
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Change in points Brief fatigue inventory (BFI)
The instrument consists of nine items, each rated on a scale from 0 to 10, aimed at assessing fatigue. By averaging the scores of all items, a fatigue score is derived, wherein higher values signify more severe fatigue.
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA
Measurement in blood samples, the insulin will evaluate by ELISA using the Human Insulin ELISA Kit, following the manufacturer's recommendations
Measured: Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery
Change in pathological complete response rate
Measured according to Sataloff criteria.
Measured: Before training (week 0), and after training (up to 20 weeks)
Change quantification proteins
It will be measured from a muscle sample obtained at the time of surgery using the western blot technique.
Measured: Before training (week 0), and after training (up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Nasri Marzuca-Nassr, Universidad de La Frontera
- Investigators
- Gabriel N Marzuca-Nassr, PT, MSc, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309290
- Sponsor's protocol ID
- FAPESP-UFRO
- Acronym
- NEO STRONG
- Status last verified
- Jun 2026
- First submitted
- 29 Feb 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No