Clinical trial · Interventional
Prehabilitation for Women Undergoing Pre-operative Chemotherapy for Breast Cancer
A Randomized Controlled Feasibility Study Comparing a Multimodal Prehabilitation Protocol to Normal Care for Women Undergoing Neo-adjuvant Chemotherapy for Breast Cancer
NCT03564171CI-TRIAL-00065524completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation, and quality of life with a multimodal prehabilitation protocol for women with breast cancer undergoing neo-adjuvant chemotherapy for breast cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Feasibility Studies | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Patients will receive standard treatment without added intervention.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- These patients will receive standard treatment plus multimodal intervention (prehabilitation program) including : exercise, nutritional counseling, stress counseling, smoking cessation) before starting chemotherapy.
- interventionNames
- Combination Product: Prehabilitation
Primary outcomes (4)
- measure
- Recruitment rate (percent reported by the research analyst )
- timeFrame
- 18 month
- description
- What percent of eligible patients were successfuly recruitted in the study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years and older, able to give consent, ECOG 0-1 Exclusion Criteria: * pregnant, \> 80 years, medical contraindications to exercise. History of severe and persistent mental illness, cognitive impairment, recent suicide attempts or \>11 on "Hospital Anxiety and Depression Scale". If very active (\> 24) on the Godin-Shephard scale.
References
Publications (0)
Data not yet available
No reference posted for this study.