Cancer, MetastaticOncolabNCT03879096
Clinical and Functional Variables in Oncology
A study testing Therapeutic Exercise and Education in people with Cancer, Metastatic and Cancer, run by University of Malaga at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Metastatic, Cancer, Survivorship
- What is being tested?
- Therapeutic Exercise and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2016to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Functional Variables in the Assessment of Oncology Patient
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
Read the 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.
- Conditions
- Cancer, Metastatic, Cancer, Survivorship
- Being tested
- Therapeutic Exercise and Education
- Keywords
- cancer, oncology, Metastasis, survivors, Exercise Therapy, Therapeutics, Complementary Therapies, fatigue, assesment
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Exercise and EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The sample will receive of a Therapeutic Exercise and Education programme Receives: Other: Therapeutic Exercise and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Cancer-Related Fatigue (CRF)
The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used
Measured: Prior and after intervention, an average of 3 months
Change from Functional capacity
It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
Measured: prior and after intervention, an average of 3 months
Change from Upper limb functionality (%)
the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled
Measured: prior and after intervention, an average of 3 months
Change from Lower limb functionality(%)
the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled
Measured: prior and after intervention, an average of 3 months
Secondary outcomes (12)
Body Composition
BMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A
Measured: prior and after intervention, an average of 3 months
Change from Body Mass Index
Body Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2)
Measured: prior and after intervention, an average of 3 months
Change from Basal Metabolism
the number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A
Measured: prior and after intervention, an average of 3 months
Change from fat mass
The fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Measured: prior and after intervention, an average of 3 months
Change from lean mass
The lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Measured: prior and after intervention, an average of 3 months
Change from water balance
Water weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Measured: prior and after intervention, an average of 3 months
Change from Physical activity (METS)
The International Physical Activity Questionnaire-Short Form (IPAQ-SF) questionnaire will be employed
Measured: prior and after intervention, an average of 3 months
Change from Handgrip Strength (Kg)
Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001
Measured: prior and after intervention, an average of 3 months
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
Measured: prior and after intervention, an average of 3 months
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)
Measured: prior and after intervention, an average of 3 months
Change from Muscle thickness
In biceps and cuadriceps muscles, both during relaxation and contraction.
Measured: prior and after intervention, an average of 3 months
Change from Grip Strength (dynamometry)
maximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg)
Measured: prior and after intervention, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 May 2016
- Primary completion1 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cancer, MetastaticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879096
- Sponsor's protocol ID
- ClubCam
- Acronym
- Oncolab
- Status last verified
- May 2020
- First submitted
- 11 Mar 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22157640Cuesta-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.
PubMed 23947581Dethlefsen 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.
PubMed 27601139Cuesta-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.
PubMed 26732120Cantarero-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.
PubMed 23695719Roldan-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.
PubMed 26506612Gerritsen 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.
PubMed 26719503Escriche-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.
PubMed 36071122Roldan-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.
PubMed 34463835
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Variables in the Assessment of Oncology Patient
- ClinicalTrials.gov ID
- NCT03879096
- Acronym / sponsor ID
- Oncolab / ClubCam
- Conditions
- Cancer, Metastatic, Cancer, Survivorship
- Keywords
- cancer, oncology, Metastasis, survivors, Exercise Therapy, Therapeutics, Complementary Therapies, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Therapeutic Exercise and EducationThe sample will receive of a Therapeutic Exercise and Education programme |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Exercise and EducationIntervention 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. | Other | Experimental |
Primary outcome
Change from Cancer-Related Fatigue (CRF)
Time frame: Prior and after intervention, an average of 3 months
The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used
Change from Functional capacity
Time frame: prior and after intervention, an average of 3 months
It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
Change from Upper limb functionality (%)
Time frame: prior and after intervention, an average of 3 months
the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled
Change from Lower limb functionality(%)
Time frame: prior and after intervention, an average of 3 months
the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled
12 secondary outcomes
Body Composition
Time frame: prior and after intervention, an average of 3 months
Change from Body Mass Index
Time frame: prior and after intervention, an average of 3 months
Change from Basal Metabolism
Time frame: prior and after intervention, an average of 3 months
Change from fat mass
Time frame: prior and after intervention, an average of 3 months
Change from lean mass
Time frame: prior and after intervention, an average of 3 months
Change from water balance
Time frame: prior and after intervention, an average of 3 months
Change from Physical activity (METS)
Time frame: prior and after intervention, an average of 3 months
Change from Handgrip Strength (Kg)
Time frame: prior and after intervention, an average of 3 months
Change fromQuality of life (self-reported questionnaire)
Time frame: prior and after intervention, an average of 3 months
Change from specific Breast Cancer Quality of life (self-reported questionnaire)
Time frame: prior and after intervention, an average of 3 months
Change from Muscle thickness
Time frame: prior and after intervention, an average of 3 months
Change from Grip Strength (dynamometry)
Time frame: prior and after intervention, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 22157640Quinten 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.
- Background: PubMed 23947581Cuesta-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.
- Background: PubMed 27601139Dethlefsen 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.
- Background: PubMed 26732120Cuesta-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.
- Background: PubMed 23695719Cantarero-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.
- Background: PubMed 26506612Roldan-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.
- Background: PubMed 26719503Gerritsen 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.
- Derived from this study: PubMed 36071122Escriche-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.
- Derived from this study: PubMed 34463835Roldan-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise and Education in people with Cancer, Metastatic and Cancer, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Cancer-Related Fatigue (CRF) (time frame: Prior and after intervention, an average of 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879096, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.