Clinical and Functional Variables in Oncology

Cancer Clinical Trial

— Oncolab  

Official title:

Clinical and Functional Variables in the Assessment of Oncology Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879096
• Other study ID #: ClubCam
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2020
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer, Metastatic
• Neoplasms
• Survivorship

Intervention

Other:
• Therapeutic Exercise and Education
Intervention will consisted of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualised based on the evaluations of muscular strength and endurance as well as the determination of the aerobic-anaerobic zone transition. Sessions lasted 1 hour, carried out twice a week, during 12 weeks. This intervention will be complemented by nutritional education.

Locations

Country	Name	City	State
Spain	Antonio Cuesta Vargas	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Cancer-Related Fatigue (CRF)	The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used	Prior and after intervention, an average of 3 months
Primary	Change from Functional capacity	It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.	prior and after intervention, an average of 3 months
Primary	Change from Upper limb functionality (%)	the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled	prior and after intervention, an average of 3 months
Primary	Change from Lower limb functionality(%)	the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled	prior and after intervention, an average of 3 months
Secondary	Body Composition	BMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A	prior and after intervention, an average of 3 months
Secondary	Change from Body Mass Index	Body Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2)	prior and after intervention, an average of 3 months
Secondary	Change from Basal Metabolism	the number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A	prior and after intervention, an average of 3 months
Secondary	Change from fat mass	The fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A	prior and after intervention, an average of 3 months
Secondary	Change from lean mass	The lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A	prior and after intervention, an average of 3 months
Secondary	Change from water balance	Water weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A	prior and after intervention, an average of 3 months
Secondary	Change from Physical activity (METS)	The International Physical Activity Questionnaire-Short Form (IPAQ-SF) questionnaire will be employed	prior and after intervention, an average of 3 months
Secondary	Change from Handgrip Strength (Kg)	Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001	prior and after intervention, an average of 3 months
Secondary	Change fromQuality of life (self-reported questionnaire)	It will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0	prior and after intervention, an average of 3 months
Secondary	Change from specific Breast Cancer Quality of life (self-reported questionnaire)	It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23)	prior and after intervention, an average of 3 months
Secondary	Change from Muscle thickness	In biceps and cuadriceps muscles, both during relaxation and contraction.	prior and after intervention, an average of 3 months
Secondary	Change from Grip Strength (dynamometry)	maximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg)	prior and after intervention, an average of 3 months