Clinical trial · Interventional
Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer
Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer: Randomized Clinical Trial.
- 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)
This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer. The study hypothesis is that participation in this exercise program improves tolerance to chemotherapy, allowing patients to receive more than 85% of the planned relative dose intensity. In addition, the program is expected to enhance treatment effectiveness by increasing the rate of complete radiological response. The main objective of the study is to assess the effectiveness of a supervised, multimodal therapeutic exercise program performed before and during chemotherapy in improving both treatment tolerance and treatment efficacy in patients with breast, lung, and colon cancer.
Conditions
Conditions (6)
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 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer (Non-Small Cell) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Neoadjuvant Chemotherapy Tolerance | — | UNRESOLVED | — |
| Physical Activity | — | UNRESOLVED | — |
| Strength and Endurance | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PREDU Exercise Program | Other | — | UNRESOLVED |
| Recommendation Exercise Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- An exercise program based on guidance provided during the informational session and the provided brochure is followed, without planning, adaptation, or supervision. Recommendations include aerobic and strength training exercises.
- interventionNames
- Other: Recommendation Exercise Program
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- A supervised, planned, and adapted therapeutic physical exercise program is implemented according to fatigue levels and the phase of the neoadjuvant chemotherapy cycle. The program includes three supervised sessions per week combining aerobic and strength training exercises.
- interventionNames
- Other: PREDU Exercise Program
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women and men aged 35 to 65 years * Diagnosed with stage II, III, or IV breast, lung, or colon cancer * Scheduled to start neoadjuvant chemotherapy * Able and willing to provide written informed consent Exclusion Criteria: * Musculoskeletal or neurological disorders that prevent proper execution of the exercises * Uncontrolled infections or symptoms * Comorbidities such as chronic obstructive pulmonary disease (COPD), respiratory failure, or recent cardiovascular events within the past 6 months * Body mass index (BMI) over 35 * Pregnant women * Difficulty understanding the purpose and procedures of the study
References
Publications (19)
- BACKGROUNDKjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416. PMID 40788186
- BACKGROUNDSchmidt ME, Goldschmidt S, Kreutz C, Muller J, Schneeweiss A, May AM, Rosenberger F, Wiskemann J, Steindorf K. Effects of aerobic or resistance exercise during neoadjuvant chemotherapy on tumor response and therapy completion in women with breast cancer: The randomized controlled BENEFIT trial. J Sport Health Sci. 2025 Dec;14:101064. doi: 10.1016/j.jshs.2025.101064. Epub 2025 May 28. PMID 40447136
- BACKGROUNDOrmel HL, van der Schoot GGF, Sluiter WJ, Jalving M, Gietema JA, Walenkamp AME. Predictors of adherence to exercise interventions during and after cancer treatment: A systematic review. Psychooncology. 2018 Mar;27(3):713-724. doi: 10.1002/pon.4612. Epub 2018 Jan 26. PMID 29247584
- BACKGROUNDBut-Hadzic J, Dervisevic M, Karpljuk D, Videmsek M, Dervisevic E, Paravlic A, Hadzic V, Tomazin K. Six-Minute Walk Distance in Breast Cancer Survivors-A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2021 Mar 5;18(5):2591. doi: 10.3390/ijerph18052591. PMID 33807611
- BACKGROUNDvan der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov. PMID 36444224
- BACKGROUNDGroen WG, Naaktgeboren WR, van Harten WH, van Vulpen JK, Kool N, Sonke GS, van der Wall E, Velthuis MJ, Aaronson NK, May AM, Stuiver MM. Physical Fitness and Chemotherapy Tolerance in Patients with Early-Stage Breast Cancer. Med Sci Sports Exerc. 2022 Apr 1;54(4):537-542. doi: 10.1249/MSS.0000000000002828.