Head and Neck CancerNCT02572869
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
An observational study of Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- physical exam and questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2015to 16 Aug 2019
- Phase
- Observational
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients will be identified from the institutional databases. Preliminary queries indicate that approximately 61 patients are eligible and currently alive.
Who may be able to join
- Able to read and write in the English language
- Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
- Able to travel to the MSK outpatient clinic or have access to email, the MSK patient portal and a computer with a camera for the follow up examination by a physician and completion of the questionnaires.
Who cannot join
- Patients who underwent marginal mandibulectomy
- Patients who underwent mandibular reconstruction with a different type of vascularized bone free flap
- Patients who underwent mandibular reconstruction with soft tissue free flap
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.
- Conditions
- Head and Neck Cancer
- Being tested
- physical exam, questionnaires
- Keywords
- Mandible Reconstruction, Fibula Osteomyocutaneous Free Flaps, Quality of Life, 15-244
- 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.
physical examOther
Patients will be examined by the treating physician or his/her designee (Fellow). The examining physician will complete an 11-item clinical examination form about the patient's clinical function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech, drooling, diet, appearance, oral sensation, and shoulder movement. Where appropriate, the physician will ask the patient questions regarding items on the questionnaire to ensure the completeness and accuracy of the outcome assessment.
questionnairesBehavioural
The participating patients will be asked to complete three questionnaires:
(1) The European Organization for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (EORTC H\&N 35) to assess their quality of life as it relates to their mandible function and aesthetic appearance (2) The EORTC QLQ-C30, which assesses overall health-related quality of life (3) The FACE-Q Oncology Module: Mandibulectomy, which contains questions regarding both functional and aesthetic outcomes.
| Study group | Role | What they receive |
|---|---|---|
| segmental mandibulectomy and free fibular flap reconstruction | Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014 Receives: Other: physical exam; Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term functional (11-item clinical examination form which documents the patient's oral function)
The examining physician will then complete an 11-item clinical examination form which documents the patient's oral function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech,drooling, diet, appearance, oral sensation, and shoulder movement.
Measured: 1 year
Long-term aesthetic outcome evaluated by photographs
archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start30 Sep 2015
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jatin Shah, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572869
- Sponsor's protocol ID
- 15-244
- Status last verified
- Aug 2019
- First submitted
- 1 Oct 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
- ClinicalTrials.gov ID
- NCT02572869
- Acronym / sponsor ID
- 15-244
- Conditions
- Head and Neck Cancer
- Keywords
- Mandible Reconstruction, Fibula Osteomyocutaneous Free Flaps, Quality of Life, 15-244
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 9 Oct 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.
The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| segmental mandibulectomy and free fibular flap reconstruction | – | Other: physical exam, Behavioral: questionnairesPatients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients will be identified from the institutional databases. Preliminary queries indicate that approximately 61 patients are eligible and currently alive.
Key inclusion criteria (3 listed)
- Able to read and write in the English language
- Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
- Able to travel to the MSK outpatient clinic or have access to email, the MSK patient portal and a computer with a camera for the follow up examination by a physician and completion of the questionnaires.
Key exclusion criteria (3 listed)
- Patients who underwent marginal mandibulectomy
- Patients who underwent mandibular reconstruction with a different type of vascularized bone free flap
- Patients who underwent mandibular reconstruction with soft tissue free flap
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 examPatients will be examined by the treating physician or his/her designee (Fellow). The examining physician will complete an 11-item clinical examination form about the patient's clinical function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech, drooling, diet, appearance, oral sensation, and shoulder movement. Where appropriate, the physician will ask the patient questions regarding items on the questionnaire to ensure the completeness and accuracy of the outcome assessment. | Other | segmental mandibulectomy and free fibular flap reconstruction |
| questionnairesThe participating patients will be asked to complete three questionnaires: (1) The European Organization for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (EORTC H\&N 35) to assess their quality of life as it relates to their mandible function and aesthetic appearance (2) The EORTC QLQ-C30, which assesses overall health-related quality of life (3) The FACE-Q Oncology Module: Mandibulectomy, which contains questions regarding both functional and aesthetic outcomes. | Behavioural | segmental mandibulectomy and free fibular flap reconstruction |
Primary outcome
Long-term functional (11-item clinical examination form which documents the patient's oral function)
Time frame: 1 year
The examining physician will then complete an 11-item clinical examination form which documents the patient's oral function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech,drooling, diet, appearance, oral sensation, and shoulder movement.
Long-term aesthetic outcome evaluated by photographs
Time frame: 1 year
archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.
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 Aug 2019.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jatin Shah, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
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 3 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Long-term functional (11-item clinical examination form which documents the patient's oral function) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Aug 2019.