Recurrent Oropharynx CarcinomaFUNQOLRNCT04952922
Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer
An observational study of Recurrent Oropharynx Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Oropharynx Carcinoma
- What is being tested?
- Treatment for recurrent oropharyngeal cancer (curative/ palliative)
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2021to 13 May 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of recurrent, residual or new primary oropharyneal cancer in a previously irradiated field.
Who may be able to join
- Adult (aged 18 years or over) competent to provide consent
- Have a diagnosis of recurrent OPC
- Have adequate linguistic and cognitive function to participate in interview
- English speaking
Who cannot join
- Any previous medical condition, other than HNC, which has a known impact on communication/ swallowing (Parkinson's Disease, Multiple Sclerosis, cerebral vascular accident (CVA)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.
- Conditions
- Recurrent Oropharynx Carcinoma
- Being tested
- Treatment for recurrent oropharyngeal cancer (curative/ palliative)
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for recurrent oropharyngeal cancer (curative/ palliative)Other
Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Swallowing Related Quality of Life
Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores
Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public
Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head \& neck related symptoms)
Total score Scale 0 -100, a higher score indicating better performance/higher quality of life
The score reported is the combined score with the total being the sum of the sub-scale scores
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
Swallowing Status Measured Using the 100ml Water Swallow Test
The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task.
Measured: Baseline, 3 months, 6 months
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew)
A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start27 Oct 2021
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Oropharynx CarcinomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952922
- Sponsor's protocol ID
- CCR5242
- Acronym
- FUNQOLR
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2021
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04952922
- Acronym / sponsor ID
- FUNQOLR / CCR5242
- Conditions
- Recurrent Oropharynx Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of recurrent, residual or new primary oropharyneal cancer in a previously irradiated field.
Key inclusion criteria (4 listed)
- Adult (aged 18 years or over) competent to provide consent
- Have a diagnosis of recurrent OPC
- Have adequate linguistic and cognitive function to participate in interview
- English speaking
Key exclusion criteria (1 listed)
- Any previous medical condition, other than HNC, which has a known impact on communication/ swallowing (Parkinson's Disease, Multiple Sclerosis, cerebral vascular accident (CVA)
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 |
|---|---|---|
| Treatment for recurrent oropharyngeal cancer (curative/ palliative)Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy. | Other | – |
Primary outcome
Patient Reported Swallowing Related Quality of Life
Time frame: Baseline, 3 months, 6 months
Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head \& neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores
2 secondary outcomes
Swallowing Status Measured Using the 100ml Water Swallow Test
Time frame: Baseline, 3 months, 6 months
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
Time frame: Baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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?
An observational study of Recurrent Oropharynx Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 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 8 Aug 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Reported Swallowing Related Quality of Life (time frame: Baseline, 3 months, 6 months). 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 8 Aug 2025.