Oesophageal CancerNCT02774551
Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength
A study testing Physical activity intervention group in people with Oesophageal Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This intervention study will be conducted on patients included in a nationwide and prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Physical activity intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients from the nationwide prospective cohort the Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR) with willingness to participate
Who cannot join
- Current malignancies or co-morbidities, psychological or social conditions that prevent participation
- Patients with pacemakers; cochlear or other electrical implants cannot be screened using the bio-impedance scale for safety reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors
This intervention study will be conducted on patients included in a nationwide and prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between 2013-2018, identified through pathology departments and included in the cohort 1 year after surgery. A comprehensive interview is conducted by a research nurse during a home visit using patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects. Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.
All patients within OSCAR are invited to the intervention trial. Half of the eligible patients will be randomised to intervention and half to standard care (control group) by means of block randomisation method. The intervention group will be encouraged to adhere to a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple strength training exercises twice a week as instructed by the research nurse. The control group will follow their routine daily physical activity. HRQOL measures, height and weight, body composition, muscle strength, functional mobility and strength, and dietary intake are assessed before and after the intervention. Compliance will be ensured by means of a daily physical activity dairy and a weekly follow up on telephone with all patients.
- Conditions
- Oesophageal Cancer
- Being tested
- Physical activity intervention group
- Keywords
- Body composition, Muscle strength, Health related quality of life
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity intervention groupBehavioural
150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention group | Experimental | The physical activity program includes 150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week are demonstrated by the research nurse. The resistance training is progressive by increasing resistance in the band based on patient's adaptability during the intervention. Receives: Behavioral: Physical activity intervention group |
| Standard care control group | No intervention | Patients follow their routine daily physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
The main outcome measure will be increase in skeletal muscle mass using a bio-impedance analysis portable monitor. Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
Measured: At baseline and after the 12 weeks intervention/control programme.
Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
The main outcome measure will be increase in skeletal muscle strength using a handgrip dynamometer and 30 second sit stand test. Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
Measured: At baseline and after the 12 weeks intervention/control programme.
Secondary outcomes (7)
Number of participants with improvement in physical function scale of health related quality of life as assessed from the questionnaire - European Organization for Research and Treatment of Cancer (EORTC); Quality of Life Questionnaire (QLQ) - C30.
This secondary outcome will assess the physical function scale of HRQOL using EORTC QLQ-C30 questionnaires before and after the intervention.
Measured: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
This secondary outcome will assess the fatigue scale of HRQOL using EORTC fatigue questionnaire QLQ-FA13 before and after the intervention.
Measured: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in appetite loss function of health related quality of life as assessed from the oesophageal disease specific module - EORTC QLQ-OG25.
This secondary outcome will assess the appetite loss function of HRQOL using EORTC QLQ-OG25 questionnaire before and after the intervention.
Measured: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in eating difficulties scale of health related quality of life as assessed from the cachexia module of EORTC - QLQ-CAX24.
This secondary outcome will assess the eating difficulties scale of HRQOL using EORTC QLQ-CAX24 questionnaire before and after the intervention.
Measured: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
This secondary outcome will assess the psychosocial issues using HADS questionnaire before and after the intervention.
Measured: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
This secondary outcome shall include changes in the total physical activity level measured using the international physical activity questionnaire (IPAQ) before and after the intervention.
Measured: At baseline and after the 12 weeks intervention/control programme.
Number of participants with improvement in dietary intake measured using 3 day food diary.
This secondary outcome shall include changes in dietary intake measured using food dairy measured thrice a week: two weekdays and 1 weekend day before and after the intervention.
Measured: Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2020
- Study completionJun 2020
Why it stopped: Closed for recruitment March 2020 due to the ongoing covid-19 situation and the termination of the study inclusion was done in August 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pernilla Lagergren, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774551
- Sponsor's protocol ID
- PA study
- Status last verified
- Dec 2020
- First submitted
- 28 Apr 2016
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Anandavadivelan P, Malberg K, Vikstrom K, Nielsen S, Holdar U, Johar A, Lagergren P. Home-based physical activity after treatment for esophageal cancer-A randomized controlled trial. Cancer Med. 2023 Feb;12(3):3477-3487. doi: 10.1002/cam4.5131. Epub 2022 Aug 18.
PubMed 36812121
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors
- ClinicalTrials.gov ID
- NCT02774551
- Acronym / sponsor ID
- PA study
- Conditions
- Oesophageal Cancer
- Keywords
- Body composition, Muscle strength, Health related quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed for recruitment March 2020 due to the ongoing covid-19 situation and the termination of the study inclusion was done in August 2020.
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
This intervention study will be conducted on patients included in a nationwide and prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between 2013-2018, identified through pathology departments and included in the cohort 1 year after surgery. A comprehensive interview is conducted by a research nurse during a home visit using patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects. Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.
All patients within OSCAR are invited to the intervention trial. Half of the eligible patients will be randomised to intervention and half to standard care (control group) by means of block randomisation method. The intervention group will be encouraged to adhere to a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple strength training exercises twice a week as instructed by the research nurse. The control group will follow their routine daily physical activity. HRQOL measures, height and weight, body composition, muscle strength, functional mobility and strength, and dietary intake are assessed before and after the intervention. Compliance will be ensured by means of a daily physical activity dairy and a weekly follow up on telephone with all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention group | Experimental | Behavioral: Physical activity intervention groupThe physical activity program includes 150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week are demonstrated by the research nurse. The resistance training is progressive by increasing resistance in the band based on patient's adaptability during the intervention. |
| Standard care control group | No intervention | –Patients follow their routine daily physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients from the nationwide prospective cohort the Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR) with willingness to participate
Key exclusion criteria (2 listed)
- Current malignancies or co-morbidities, psychological or social conditions that prevent participation
- Patients with pacemakers; cochlear or other electrical implants cannot be screened using the bio-impedance scale for safety reasons
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 |
|---|---|---|
| Physical activity intervention group150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week. | Behavioural | Physical activity intervention group |
Primary outcome
Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
Time frame: At baseline and after the 12 weeks intervention/control programme.
The main outcome measure will be increase in skeletal muscle mass using a bio-impedance analysis portable monitor. Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
Time frame: At baseline and after the 12 weeks intervention/control programme.
The main outcome measure will be increase in skeletal muscle strength using a handgrip dynamometer and 30 second sit stand test. Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
7 secondary outcomes
Number of participants with improvement in physical function scale of health related quality of life as assessed from the questionnaire - European Organization for Research and Treatment of Cancer (EORTC); Quality of Life Questionnaire (QLQ) - C30.
Time frame: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
Time frame: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in appetite loss function of health related quality of life as assessed from the oesophageal disease specific module - EORTC QLQ-OG25.
Time frame: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in eating difficulties scale of health related quality of life as assessed from the cachexia module of EORTC - QLQ-CAX24.
Time frame: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
Time frame: At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
Time frame: At baseline and after the 12 weeks intervention/control programme.
Number of participants with improvement in dietary intake measured using 3 day food diary.
Time frame: Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
Results and safety
The study was stopped early (reason given: Closed for recruitment March 2020 due to the ongoing covid-19 situation and the termination of the study inclusion was done in August 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 36812121Anandavadivelan P, Malberg K, Vikstrom K, Nielsen S, Holdar U, Johar A, Lagergren P. Home-based physical activity after treatment for esophageal cancer-A randomized controlled trial. Cancer Med. 2023 Feb;12(3):3477-3487. doi: 10.1002/cam4.5131. Epub 2022 Aug 18.
- Individual participant dataSharing planned: No
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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.
Pernilla Lagergren, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention group in people with Oesophageal Cancer, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Dec 2020. 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 Sweden. 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 was stopped early (reason given: Closed for recruitment March 2020 due to the ongoing covid-19 situation and the termination of the study inclusion was done in August 2020.). Results are not available in the source record.
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?
Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale. (time frame: At baseline and after the 12 weeks intervention/control programme.). The study lists 2 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 NCT02774551, which also lists 1 linked publication.
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 14 Dec 2020.