Clinical trial NCT03879096: Clinical and Functional Variables in Oncology
Official title: Clinical and Functional Variables in the Assessment of Oncology Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Metastatic
Cancer
Survivorship
Keywords: cancer
oncology
Metastasis
survivors
Exercise Therapy
Therapeutics
Complementary Therapies
fatigue
assesment
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim is to analyse the effect of a Therapeutic Exercise and Education programme in several clinical and functional outcomes in cancer patient and survivors

Detailed description: In the oncology field, both patients and survivors have to face several symptoms, like cancer-related fatigue or pain. Cancer patients also have affected quality of life, lower levels of function and they are at higher risk of weight gain following diagnosis. Given the risk of obesity, both exercise and diet play a key role in recovery from cancer.

Hence, the aim of this study is to show the effect of a Therapeutic Exercise and Education programme (TEEP) in clinical and functional, including practical nutritional education in other clinical and functional secondary outcomes in cancer patients and survivors.

Variables included are: body composition, mediterranean-diet adherence, quality of life (QoL) and functional outcomes (limb functionality, physical activity, physical function and handgrip strength). Furthermore, laboratory variables like muscle thickness (ecography) and muscle activity (electromyography) were included.

Eligibility criteria: Inclusion Criteria:

* In the case of survivors: Patient who had been surgically treated for their primary tumour with no evidence of recurrence at the time of recruitment. The inclusion of patients undergoing hormonal treatment radiotherapy or antiHER therapy will be allowed.
* In the case of cancer patients: patient who had been dignosed by cancer.

In both cases, all participants have to maintain the minimum physical function to perform exercise in group.

Exclusion Criteria:

* Patients were excluded if they had suffered any cardiovascular event defined as stable or unstable angor, acute pulmonary edema, cardiac rhythm disorders, or syncope of cause not affiliated in the year prior to inclusion

Primary outcomes:
measure: Change from Cancer-Related Fatigue (CRF)
timeFrame: Prior and after intervention, an average of 3 months
measure: Change from Functional capacity
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Upper limb functionality (%)
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Lower limb functionality(%)
timeFrame: prior and after intervention, an average of 3 months
Secondary outcomes:
measure: Body Composition
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Body Mass Index
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Basal Metabolism
timeFrame: prior and after intervention, an average of 3 months
measure: Change from fat mass
timeFrame: prior and after intervention, an average of 3 months
measure: Change from lean mass
timeFrame: prior and after intervention, an average of 3 months
measure: Change from water balance
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Physical activity (METS)
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Handgrip Strength (Kg)
timeFrame: prior and after intervention, an average of 3 months
measure: Change fromQuality of life (self-reported questionnaire)
timeFrame: prior and after intervention, an average of 3 months
measure: Change from specific Breast Cancer Quality of life (self-reported questionnaire)
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Muscle thickness
timeFrame: prior and after intervention, an average of 3 months
measure: Change from Grip Strength (dynamometry)
timeFrame: prior and after intervention, an average of 3 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Antonio Cuesta Vargas
Study officials:
References:
citation: Quinten C, Maringwa J, Gotay CC, Martinelli F, Coens C, Reeve BB, Flechtner H, Greimel E, King M, Osoba D, Cleeland C, Ringash J, Schmucker-Von Koch J, Taphoorn MJ, Weis J, Bottomley A. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011 Dec 21;103(24):1851-8. doi: 10.1093/jnci/djr485. Epub 2011 Dec 7.
citation: Cuesta-Vargas AI, Buchan J, Arroyo-Morales M. A multimodal physiotherapy programme plus deep water running for improving cancer-related fatigue and quality of life in breast cancer survivors. Eur J Cancer Care (Engl). 2014 Jan;23(1):15-21. doi: 10.1111/ecc.12114. Epub 2013 Aug 16.
citation: Dethlefsen C, Lillelund C, Midtgaard J, Andersen C, Pedersen BK, Christensen JF, Hojman P. Exercise regulates breast cancer cell viability: systemic training adaptations versus acute exercise responses. Breast Cancer Res Treat. 2016 Oct;159(3):469-79. doi: 10.1007/s10549-016-3970-1. Epub 2016 Sep 6.
citation: Cuesta-Vargas AI, Carabantes F, Caracuel Z, Conejo I, Alba E. Effectiveness of an individualized program of muscular strength and endurance with aerobic training for improving germ cell cancer-related fatigue in men undergoing chemotherapy: EFICATEST study protocol for a randomized controlled trial. Trials. 2016 Jan 5;17:8. doi: 10.1186/s13063-015-1143-x.
citation: Cantarero-Villanueva I, Fernandez-Lao C, Diaz-Rodriguez L, Cuesta-Vargas AI, Fernandez-de-las-Penas C, Piper BF, Arroyo-Morales M. The Piper Fatigue Scale-Revised: translation and psychometric evaluation in Spanish-speaking breast cancer survivors. Qual Life Res. 2014 Feb;23(1):271-6. doi: 10.1007/s11136-013-0434-5. Epub 2013 May 22.
citation: Roldan-Jimenez C, Bennett P, Cuesta-Vargas AI. Muscular Activity and Fatigue in Lower-Limb and Trunk Muscles during Different Sit-To-Stand Tests. PLoS One. 2015 Oct 27;10(10):e0141675. doi: 10.1371/journal.pone.0141675. eCollection 2015.
citation: Gerritsen JK, Vincent AJ. Exercise improves quality of life in patients with cancer: a systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2016 Jul;50(13):796-803. doi: 10.1136/bjsports-2015-094787. Epub 2015 Dec 30.
citation: Escriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Garcia-Almeida JM, Roldan-Jimenez C, Cuesta-Vargas AI. Responsiveness of the new index muscular echotexture in women with metastatic breast cancer: an exercise intervention study. Sci Rep. 2022 Sep 7;12(1):15148. doi: 10.1038/s41598-022-19532-7.
citation: Roldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31.