Neack and Head CancerSEHNeCaNCT04658706
The SEHNeCa Supervised Exercise Project
A study testing A supervised exercise program and exercise prescription in people with Neack and Head Cancer and Supervised Execise Program, run by Basque Health Service at 1 site in Spain.
Trial summary
Objectives: To evaluate the effectiveness and efficiency of an innovative supervised exercise program for patients with head and neck cancer (SEHNeCa) to ameliorate loss of lean body mass, functional capacity and quality of life during one year, compared to a reference group receiving a physical activity prescription… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neack and Head Cancer, Supervised Execise Program
- What is being tested?
- A supervised exercise program and exercise prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosed locally advanced stage III-IVa-b with squamous cell carcinomas of the larynx, pharynx, oral cavity, salivary or in neck lymph nodes from an unknown primary tumour (TNM 9th AJCC classification; 2019.) treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy (with or without previous surgery).
- Age: more than 18 years
- WHO performance status of 0-1 (IK 80%)
- Body mass index: more than 18.5.
- No evidence of metastatic disease
- No excessive alcohol intake (men > 21 and women > 14 units/week)
- No current or previous malignancies that could prevent participation and training
- No recent systematic resistance training.
Who cannot join
- Decompensated heart disease, uncontrolled hypertension (TAS>200 o TAD>110), cardiac insufficiency (NYHA II o mayor), heart failure or constrictive pericarditis, Neutropenia, severe anemia ( Hb<8.0 g/dl), platelets count <50.000 microL
- Other health problems in which exercise is contraindicated.
- Carry out physical activity regularly (150 min/week of moderate activity or 75 of vigorous activity), measured with the PVS questionarie.
- Pregnancy
- Tracheostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Exercise for Head and Neck Cancer Patients Initiated Previously or After Treatment: the SEHNeCa Randomized Controlled Trial
Objectives:
- To evaluate the effectiveness and efficiency of an innovative supervised exercise program for patients with head and neck cancer (SEHNeCa) to ameliorate loss of lean body mass, functional capacity and quality of life during one year, compared to a reference group receiving a physical activity prescription to be performed autonomously.
- To identify the optimal timing for applying the supervised exercise program: in a Prehabilitation period, at least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant with it, or during a Rehabilitation period, starting 12 weeks after the first radiotherapy session, once standard treatment has finished. Design: a multicenter, randomized clinical trial, where patients will be randomized to 3 groups: one control group and 2 experimental with different timing of exercise intervention. Population: 120 patients diagnosed with histological locally advanced stage III-IVa-b with squamous cell carcinomas of the larynx, pharynx, oral cavity, salivary or in neck lymph nodes from an unknown primary tumour treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy.
SEHNeCa program: is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week). Outcome measurements: main outcome variable: change in body mass index at 6 months (multy-frecuenciy imoediance). Secondary variables at basal, 7, 12, 25, and 52 weeks after the beginning of radiotherapy include quality of life (general SF-36 and cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30-),functional capacity (6 min walking test), patient reported outcomes and treatment maximum adverse events. Analyses: Differences between treatment groups in changes in outcome variables will be analyzed on an intention to treat basis. We will use linear mixed models for longitudinal analysis of repeated measurements of continuous outcomes (SAS PROC MIXED) and generalized logistic mixed models for dichotomous (SAAS PROC GLIMMIX), considering intercept and time courses as random effects and testing the significance of the interaction of time slopes by treatment group.
- Conditions
- Neack and Head Cancer, Supervised Execise Program
- Being tested
- A supervised exercise program, exercise prescription
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A supervised exercise programOther
is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week).
exercise prescriptionOther
they will receive a prescription concerning healthy lifestyles and a personalized exercise plan
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | a physical activity prescription to be performed autonomously Receives: Other: exercise prescription |
| Prehabilitation | Experimental | They will receive a supervised exercise programat least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant Receives: Other: A supervised exercise program |
| Rehabilitation | Experimental | They will receive a supervised exercise programat 12 weeks after the first radiotherapy session, once standard treatment has finished Receives: Other: A supervised exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body lean mass
change in body lean mass will be measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy) by the multi-frequency impedance measurement technique.
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Secondary outcomes (6)
Change in Quality of life
evaluated with the EORTCQLQ-C-30 questionnaire associated with the head and neck 35 specific module. Cancer specific quality of life is evaluated by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire (Aaronson et al., 1993). The QLQ-C-30 questionnaire includes five functional domains (physical, role, cognitive, emotional and social; higher scores represent greater function/quality of life) and three symptom scales (fatigue, pain and nausea; lower scores represent greater quality of life/less symptom severity)
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Functional capacity
Evaluated by the six minute walking test
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Strenght
Evaluated by a manual dynamometer for higher body and by the bench press for the lower body
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Quality of life
Evaluated by the Medical Outcomes Study 36- Item Short-Form Health Survey (SF-36). The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and. Questionnaire will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. This questionnaire has been validated in the Spanish population.
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Functional capacity
Evaluated by the shoulder pain disability index. patients place a mark on a 10cm visual analogue scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'. The scores from both dimensions are averaged to derive a total score. As more score, more pain the patients feels.
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Functional capacity
Evaluated by Fatigue-related measure with the FACIT-F test Predictor. a 13 items scale that measures the cancer related fatigue. The FACT-G scoring guide identifies those items that must be reversed before being added to obtain subscale totals. Negatively stated items are reversed by subtracting the response from "4". After reversing proper items, all subscale items are summed to a total, which is the subscale score.The higher score the score, the better the QOL.
Measured: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Jan 2023 (estimated)
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 Neack and Head CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jon Cacicedo Fernandez Bobadilla, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658706
- Sponsor's protocol ID
- PI 20/00112
- Acronym
- SEHNeCa
- Status last verified
- Feb 2021
- First submitted
- 25 Nov 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodriguez-Arietaleanizbeaskoa M, Mojas Ereno E, Arietaleanizbeaskoa MS, Grandes G, Rodriguez Sanchez A, Urquijo V, Hernando Alday I, Dublang M, Angulo-Garay G, Cacicedo J; SEHNeCa group. Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients. BMC Cancer. 2023 Mar 24;23(1):271. doi: 10.1186/s12885-023-10718-4.
PubMed 36964485
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise for Head and Neck Cancer Patients Initiated Previously or After Treatment: the SEHNeCa Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04658706
- Acronym / sponsor ID
- SEHNeCa / PI 20/00112
- Conditions
- Neack and Head Cancer, Supervised Execise Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 8 Dec 2020 (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.
Objectives:
- To evaluate the effectiveness and efficiency of an innovative supervised exercise program for patients with head and neck cancer (SEHNeCa) to ameliorate loss of lean body mass, functional capacity and quality of life during one year, compared to a reference group receiving a physical activity prescription to be performed autonomously.
- To identify the optimal timing for applying the supervised exercise program: in a Prehabilitation period, at least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant with it, or during a Rehabilitation period, starting 12 weeks after the first radiotherapy session, once standard treatment has finished. Design: a multicenter, randomized clinical trial, where patients will be randomized to 3 groups: one control group and 2 experimental with different timing of exercise intervention. Population: 120 patients diagnosed with histological locally advanced stage III-IVa-b with squamous cell carcinomas of the larynx, pharynx, oral cavity, salivary or in neck lymph nodes from an unknown primary tumour treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy.
SEHNeCa program: is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week). Outcome measurements: main outcome variable: change in body mass index at 6 months (multy-frecuenciy imoediance). Secondary variables at basal, 7, 12, 25, and 52 weeks after the beginning of radiotherapy include quality of life (general SF-36 and cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30-),functional capacity (6 min walking test), patient reported outcomes and treatment maximum adverse events. Analyses: Differences between treatment groups in changes in outcome variables will be analyzed on an intention to treat basis. We will use linear mixed models for longitudinal analysis of repeated measurements of continuous outcomes (SAS PROC MIXED) and generalized logistic mixed models for dichotomous (SAAS PROC GLIMMIX), considering intercept and time courses as random effects and testing the significance of the interaction of time slopes by treatment group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: exercise prescriptiona physical activity prescription to be performed autonomously |
| Prehabilitation | Experimental | Other: A supervised exercise programThey will receive a supervised exercise programat least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant |
| Rehabilitation | Experimental | Other: A supervised exercise programThey will receive a supervised exercise programat 12 weeks after the first radiotherapy session, once standard treatment has finished |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological diagnosed locally advanced stage III-IVa-b with squamous cell carcinomas of the larynx, pharynx, oral cavity, salivary or in neck lymph nodes from an unknown primary tumour (TNM 9th AJCC classification; 2019.) treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy (with or without previous surgery).
- Age: more than 18 years
- WHO performance status of 0-1 (IK 80%)
- Body mass index: more than 18.5.
- No evidence of metastatic disease
Key exclusion criteria (5 listed)
- Decompensated heart disease, uncontrolled hypertension (TAS>200 o TAD>110), cardiac insufficiency (NYHA II o mayor), heart failure or constrictive pericarditis, Neutropenia, severe anemia ( Hb<8.0 g/dl), platelets count <50.000 microL
- Other health problems in which exercise is contraindicated.
- Carry out physical activity regularly (150 min/week of moderate activity or 75 of vigorous activity), measured with the PVS questionarie.
- Pregnancy
- Tracheostomy.
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 |
|---|---|---|
| A supervised exercise programis a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week). | Other | Prehabilitation, Rehabilitation |
| exercise prescriptionthey will receive a prescription concerning healthy lifestyles and a personalized exercise plan | Other | Control |
Primary outcome
Change in body lean mass
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
change in body lean mass will be measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy) by the multi-frequency impedance measurement technique.
6 secondary outcomes
Change in Quality of life
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Functional capacity
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Strenght
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Quality of life
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Functional capacity
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Change in Functional capacity
Time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Derived from this study: PubMed 36964485Rodriguez-Arietaleanizbeaskoa M, Mojas Ereno E, Arietaleanizbeaskoa MS, Grandes G, Rodriguez Sanchez A, Urquijo V, Hernando Alday I, Dublang M, Angulo-Garay G, Cacicedo J; SEHNeCa group. Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients. BMC Cancer. 2023 Mar 24;23(1):271. doi: 10.1186/s12885-023-10718-4.
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 A supervised exercise program and exercise prescription in people with Neack and Head Cancer and Supervised Execise Program, run by Basque Health Service 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Change in body lean mass (time frame: Measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy). 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 NCT04658706, 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 23 Jul 2021.