Lymphedema, SecondaryNCT04196725
Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer
A study testing Physical therapy treatment and Lifestyle treatment in people with Lymphedema, Secondary, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Secondary
- What is being tested?
- Physical therapy treatment and Lifestyle treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- 6 Dec 2019to 4 Apr 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
- Secondary lymphedema in arm or/and leg related to cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. The purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.
Read the detailed description
Traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. Alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. However, the effects of such interventions are scarcely documented. Thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance.
The study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. Firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. In addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. Pre and post of each of the two week rehabilitation periods the following measurements will be performed: The magnitude of lymphedema by volume measurements of the limbs (by DXA); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.
- Conditions
- Lymphedema, Secondary
- Being tested
- Physical therapy treatment, Lifestyle treatment
- Medical subject headings
- Lymphedema, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy treatmentOther
Two weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging
Lifestyle treatmentBehavioural
Two weeks rehabilitation programme focusing on physical activity
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy treatment | Experimental | Not described Receives: Other: Physical therapy treatment |
| Lifestyle treatment | Experimental | Not described Receives: Behavioral: Lifestyle treatment |
| Control | No intervention | Parallel control group, not undertaking any treatment and not part of the cross-over design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema
Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA
Measured: Change from before to the end of each of the two week rehabilitation programmes.
Secondary outcomes (9)
Maximal strength
In handgrip and knee-extension
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Balance
One leg balance test
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Flexibility in hip and back
Sit and reach test
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Flexibility in shoulder
Back scratch test
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Test of physical functionality
Stand up and walk test
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Range of joint movement in the knee, degrees of movement measured with a protractor
Range of joint movement in the knee
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Range of joint movement in the elbow, degrees of movement measured with a protractor
Range of joint movement in the elbow
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Self perceived health
Perceived health assessed by questionnaire
Measured: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Level of physical activity
Level of physical activity assessed by questionnaire
Measured: Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start6 Dec 2019
- Primary completion4 Apr 2020
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema, SecondaryStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- 26 participants will be enrolled in the cross over design consisting of two different rehabilitation programme. In addition there will be a parallel control group with 10 participants not participating in any of the rehabilitation programmes.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Montebellosenteret, Mesnali, Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196725
- Sponsor's protocol ID
- Montebello19
- Status last verified
- Dec 2019
- First submitted
- 11 Nov 2019
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer
- ClinicalTrials.gov ID
- NCT04196725
- Acronym / sponsor ID
- Montebello19
- Conditions
- Lymphedema, Secondary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Montebellosenteret, Mesnali, Norway
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 12 Dec 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.
Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. The purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.
Detailed description
Traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. Alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. However, the effects of such interventions are scarcely documented. Thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance.
The study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. Firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. In addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. Pre and post of each of the two week rehabilitation periods the following measurements will be performed: The magnitude of lymphedema by volume measurements of the limbs (by DXA); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 26 participants will be enrolled in the cross over design consisting of two different rehabilitation programme. In addition there will be a parallel control group with 10 participants not participating in any of the rehabilitation programmes.
| Arm | Type | Receives |
|---|---|---|
| Physical therapy treatment | Experimental | Other: Physical therapy treatment |
| Lifestyle treatment | Experimental | Behavioral: Lifestyle treatment |
| Control | No intervention | –Parallel control group, not undertaking any treatment and not part of the cross-over design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Secondary lymphedema in arm or/and leg related to cancer
Key exclusion criteria (1 listed)
- -
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 therapy treatmentTwo weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging | Other | Physical therapy treatment |
| Lifestyle treatmentTwo weeks rehabilitation programme focusing on physical activity | Behavioural | Lifestyle treatment |
Primary outcome
Lymphedema
Time frame: Change from before to the end of each of the two week rehabilitation programmes.
Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA
9 secondary outcomes
Maximal strength
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Balance
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Flexibility in hip and back
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Flexibility in shoulder
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Test of physical functionality
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Range of joint movement in the knee, degrees of movement measured with a protractor
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Range of joint movement in the elbow, degrees of movement measured with a protractor
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Self perceived health
Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
Level of physical activity
Time frame: Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three 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 20 May 2020.
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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 Physical therapy treatment and Lifestyle treatment in people with Lymphedema, Secondary, run by Inland Norway University of Applied Sciences at 1 site in Norway.
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 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 20 May 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 Norway. 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?
Lymphedema (time frame: Change from before to the end of each of the two week rehabilitation programmes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2020.