Head and Neck NeoplasmsNCT02439892
Rehabilitation for Head and Neck Cancer
A study testing Exercise and nutrition during radiotherapy and Multidimensional rehabilitation after radiotherapy in people with Head and Neck Neoplasms, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Exercise and nutrition during radiotherapy and Multidimensional rehabilitation after radiotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2015to 1 Apr 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of squamous cell cancer (SCC) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity)
- Due to commence curative radiotherapy (RT) or chemoradiotherapy (CRT)
- All baseline assessments can be completed within 4 weeks prior to first cycle of RT or CRT
- Written informed consent is present
- willing to comply with study procedures
Who cannot join
- stage T1N0M0 laryngeal cancer
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial
Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Exercise and nutrition during radiotherapy, Multidimensional rehabilitation after radiotherapy
- Keywords
- Radiotherapy, Exercise, Diet therapy, Rehabilitation, Patient Compliance, Feasibility Studies, Sample Size, Patient satisfaction
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity, Patient Compliance, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and nutrition during radiotherapyBehavioural
The intervention consists of physical exercise, nutritional counselling and supplements. The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT). The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions. The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily. A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period.
Multidimensional rehabilitation after radiotherapyBehavioural
The intervention consists of physical exercise, nutritional counselling and supplements and patient education. The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT). PRT will be conducted as described in the intervention during treatment. The nutritional intervention will be carried out as described in the intervention during treatment. Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals.
| Study group | Role | What they receive |
|---|---|---|
| Early rehabilitation | Experimental | Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements. Receives: Behavioral: Exercise and nutrition during radiotherapy |
| Late rehabilitation | Active comparator | Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education Receives: Behavioral: Multidimensional rehabilitation after radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.
Measured: 15 weeks
Secondary outcomes (1)
Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, LHL-Klinikkene, Røros, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Jo-Åsmund Lund, MD PhD, Principal investigator, St. Olavs HospitalStein Kaasa, prof MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439892
- Sponsor's protocol ID
- IDR-2012-01
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2015
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sandmael JA, Bye A, Solheim TS, Stene GB, Thorsen L, Kaasa S, Lund JA, Oldervoll LM. Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot randomized trial. Cancer. 2017 Nov 15;123(22):4440-4448. doi: 10.1002/cncr.30901. Epub 2017 Jul 31.
PubMed 28759113Sandmael JA, Bye A, Solheim TS, Balstad TR, Thorsen L, Skovlund E, Kaasa S, Lund JA, Oldervoll L. Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program. Laryngoscope Investig Otolaryngol. 2020 Mar 17;5(2):330-338. doi: 10.1002/lio2.368. eCollection 2020 Apr.
PubMed 32337365
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02439892
- Acronym / sponsor ID
- IDR-2012-01
- Conditions
- Head and Neck Neoplasms
- Keywords
- Radiotherapy, Exercise, Diet therapy, Rehabilitation, Patient Compliance, Feasibility Studies, Sample Size, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, LHL-Klinikkene, Røros, Oslo University Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 12 May 2015 (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.
Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early rehabilitation | Experimental | Behavioral: Exercise and nutrition during radiotherapyExercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements. |
| Late rehabilitation | Active comparator | Behavioral: Multidimensional rehabilitation after radiotherapyMultidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of squamous cell cancer (SCC) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity)
- Due to commence curative radiotherapy (RT) or chemoradiotherapy (CRT)
- All baseline assessments can be completed within 4 weeks prior to first cycle of RT or CRT
- Written informed consent is present
- willing to comply with study procedures
Key exclusion criteria (1 listed)
- stage T1N0M0 laryngeal cancer
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 |
|---|---|---|
| Exercise and nutrition during radiotherapyThe intervention consists of physical exercise, nutritional counselling and supplements. The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT). The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions. The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily. A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period. | Behavioural | Early rehabilitation |
| Multidimensional rehabilitation after radiotherapyThe intervention consists of physical exercise, nutritional counselling and supplements and patient education. The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT). PRT will be conducted as described in the intervention during treatment. The nutritional intervention will be carried out as described in the intervention during treatment. Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals. | Behavioural | Late rehabilitation |
Primary outcome
Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.
Time frame: 15 weeks
1 secondary outcome
Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3
Time frame: 15 weeks
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 30 Apr 2020.
- Results publication: PubMed 28759113Sandmael JA, Bye A, Solheim TS, Stene GB, Thorsen L, Kaasa S, Lund JA, Oldervoll LM. Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot randomized trial. Cancer. 2017 Nov 15;123(22):4440-4448. doi: 10.1002/cncr.30901. Epub 2017 Jul 31.
- Results publication: PubMed 32337365Sandmael JA, Bye A, Solheim TS, Balstad TR, Thorsen L, Skovlund E, Kaasa S, Lund JA, Oldervoll L. Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program. Laryngoscope Investig Otolaryngol. 2020 Mar 17;5(2):330-338. doi: 10.1002/lio2.368. eCollection 2020 Apr.
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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.
Jo-Åsmund Lund, MD PhD principal investigator
St. Olavs Hospital
Stein Kaasa, prof MD principal investigator
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and nutrition during radiotherapy and Multidimensional rehabilitation after radiotherapy in people with Head and Neck Neoplasms, run by Norwegian University of Science and Technology at 2 sites 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 5 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 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence. (time frame: 15 weeks). 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 NCT02439892, which also lists 2 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 30 Apr 2020.