Head and Neck Cancer SurvivorsCaReNCT06646861
Head and Neck Cancer Rehabilitation: The CaRe Feasibility Study
A study testing Exercise in people with Head and Neck Cancer Survivors, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Introduction: As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer Survivors
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIreland
- Study dates
- 1 Nov 2024to 30 Sep 2025
- 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
- Informed Consent
- Over 18 years old
- In the first two years after treatment for head and neck cancer
- Medically fit to participate in low to moderate physical activity
Who cannot join
- Individuals with moderate or severe cognitive impairment
- Pregnancy
- Receiving treatment in the palliative setting
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate a number of negative health consequences of head and neck cancer and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes in head and neck cancer populations are lacking.
Purpose: To evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world, standard practice setting.
Read more
Methods and analysis: In this single-arm prospective feasibility study, survivors of head and neck cancer (n=29) will undergo a 10-week multi-modal exercise programme. The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre. Participants will be aged 18 or older and have completed treatment with curative intent.
Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes will examine physical function and quality of life measures. In addition, the acceptability of the programme will be assessed through patient feedback.
Ethics and dissemination: Ethical approval is pending from the St. James's Hospital and Tallaght University Hospital Research and Ethics Committee. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses and relevant clinical groups.
- Conditions
- Head and Neck Cancer Survivors
- Being tested
- Exercise
- Keywords
- Exercise, Rehabilitation, Survivorship
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A combination of aerobic, resistance, balance and flexibility exercises will be included.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Multi-modal exercise programme The 10-week multi-modal exercise programme will comprise of twice weekly online supervised group-based exercise sessions. Each exercise session will last approximately 1 hour and consist of a combination of aerobic, resistance and balance and flexibility exercises. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Programme feasibility
Recruitment rates (percentage of eligible study population that consented to participation), programme adherence (number of prescribed supervised and unsupervised sessions completed), retention, acceptability of the intervention and adverse events. Reasons for attrition or non-compliance will be identified through qualitative evaluation with participants.
Measured: From enrolment until end of study intervention at 10 weeks
Secondary outcomes (7)
The Neck Disability Index
The Neck Disability Index will assess neck pain.
Measured: From enrolment until end of study intervention at 10 weeks
Quality of Life
The functional assessment of cancer therapy head and neck questionnaire will be used to measure quality of life.
The higher the score, the better the QOL.
Measured: From enrolment until end of study intervention at 10 weeks
Physical Function
The 30 second Sit to Stand test, hand grip strength and clinical frailty scale. 30 second Sit to Stand: higher score associated with better outcomes Hand Grip Strength: higher score associated with better outcomes Clinical Frailty Scale: Lower values are associated with better outcomes
Measured: From enrolment until end of study intervention at 10 weeks
Physical Activity
Self-reported physical activity will be collected using the Godin Leisure-Time Physical Activity Questionnaire.
The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.
Measured: From enrolment until end of study intervention at 10 weeks
Cancer Related Fatigue
Brief Fatigue Inventory This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Measured: From enrolment until end of study intervention at 10 weeks
Oral Intake
The Functional Oral Intake Scale This scale reflects the functional oral intake of patients (1-7) where 7 indicates no restrictions to oral intake and better outcomes
Measured: From enrolment until end of study intervention at 10 weeks
Lymphoedema
Lymph Scanner
Measured: From enrolment until end of study intervention at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Nov 2024
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
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 Head and Neck Cancer SurvivorsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Cancer Society, St. James's Hospital, Ireland
- Responsible party
- Principal investigator, Grainne Sheill, University of Dublin, Trinity College
- Investigators
- Grainne Sheill, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646861
- Sponsor's protocol ID
- 2247
- Acronym
- CaRe
- Status last verified
- Mar 2026
- First submitted
- 11 Oct 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sheill G, Grehan S, Bennett AE, Bowe C, Broderick J, Coghlan K, Regan J, Hussey J, Connell JEO. Head and neck cancer rehabilitation: the CaRe feasibility study. Support Care Cancer. 2026 Jun 4;34(7):612. doi: 10.1007/s00520-026-10839-z.
PubMed 42240720
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Cancer Rehabilitation: The CaRe Feasibility Study
- ClinicalTrials.gov ID
- NCT06646861
- Acronym / sponsor ID
- CaRe / 2247
- Conditions
- Head and Neck Cancer Survivors
- Keywords
- Exercise, Rehabilitation, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Irish Cancer Society, St. James's Hospital, Ireland
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 17 Oct 2024 (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.
Introduction: As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate a number of negative health consequences of head and neck cancer and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes in head and neck cancer populations are lacking.
Purpose: To evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world, standard practice setting.
Methods and analysis: In this single-arm prospective feasibility study, survivors of head and neck cancer (n=29) will undergo a 10-week multi-modal exercise programme. The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre. Participants will be aged 18 or older and have completed treatment with curative intent.
Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes will examine physical function and quality of life measures. In addition, the acceptability of the programme will be assessed through patient feedback.
Ethics and dissemination: Ethical approval is pending from the St. James's Hospital and Tallaght University Hospital Research and Ethics Committee. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses and relevant clinical groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseMulti-modal exercise programme The 10-week multi-modal exercise programme will comprise of twice weekly online supervised group-based exercise sessions. Each exercise session will last approximately 1 hour and consist of a combination of aerobic, resistance and balance and flexibility exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent
- Over 18 years old
- In the first two years after treatment for head and neck cancer
- Medically fit to participate in low to moderate physical activity
Key exclusion criteria (3 listed)
- Individuals with moderate or severe cognitive impairment
- Pregnancy
- Receiving treatment in the palliative setting
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 |
|---|---|---|
| ExerciseA combination of aerobic, resistance, balance and flexibility exercises will be included. | Other | Exercise |
Primary outcome
Programme feasibility
Time frame: From enrolment until end of study intervention at 10 weeks
Recruitment rates (percentage of eligible study population that consented to participation), programme adherence (number of prescribed supervised and unsupervised sessions completed), retention, acceptability of the intervention and adverse events. Reasons for attrition or non-compliance will be identified through qualitative evaluation with participants.
7 secondary outcomes
The Neck Disability Index
Time frame: From enrolment until end of study intervention at 10 weeks
Quality of Life
Time frame: From enrolment until end of study intervention at 10 weeks
Physical Function
Time frame: From enrolment until end of study intervention at 10 weeks
Physical Activity
Time frame: From enrolment until end of study intervention at 10 weeks
Cancer Related Fatigue
Time frame: From enrolment until end of study intervention at 10 weeks
Oral Intake
Time frame: From enrolment until end of study intervention at 10 weeks
Lymphoedema
Time frame: From enrolment until end of study intervention at 10 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 25 Mar 2026.
- Derived from this study: PubMed 42240720Sheill G, Grehan S, Bennett AE, Bowe C, Broderick J, Coghlan K, Regan J, Hussey J, Connell JEO. Head and neck cancer rehabilitation: the CaRe feasibility study. Support Care Cancer. 2026 Jun 4;34(7):612. doi: 10.1007/s00520-026-10839-z.
- Individual participant dataSharing planned: Undecided
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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.
Grainne Sheill, PhD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Head and Neck Cancer Survivors, run by University of Dublin, Trinity College at 1 site in Ireland.
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 4 inclusion and 3 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 25 Mar 2026. 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 Ireland. 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?
Programme feasibility (time frame: From enrolment until end of study intervention at 10 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 NCT06646861, 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 25 Mar 2026.