Head Neck CancerPhase 2Swallowing-1NCT02075385
Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer
A Phase 2 study testing pre, during and pos-treatment swallowing exercises in people with Head Neck Cancer and Swallowing Disorders, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy. Methods and Casuistic: Randomized clinical trial phase II. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Neck Cancer, Swallowing Disorders
- What is being tested?
- pre, during and pos-treatment swallowing exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Aug 2015
- Phase
- Phase 2
- 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
- Head and neck squamous cell carcinoma
- Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy.
- Oropharynges, larynx and hypopharynx advanced cancer (T3 or T4), classified as resectable;
- 18 years old or older;
- informed consent signed before any specific procedure
Who cannot join
- Previous head and neck surgery
- Previous radiotherapy or chemotherapy
- Previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma;
- Severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy
- Patients with cognitive deficit which could not comprehend the speech pathology intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer
General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy.
Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. Patients are randomized on two groups: control group and speech pathology therapy group
Read the detailed description
To evaluate and compare the swallowing and life quality swallowing on a group undergoing to speech pathology therapy (intervention) and a control group (no intervention).
- Conditions
- Head Neck Cancer, Swallowing Disorders
- Being tested
- pre, during and pos-treatment swallowing exercises
- Keywords
- Dysphagia, speech language therapy, quality of life, induction chemotherapy, concurrent chemoradiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre, during and pos-treatment swallowing exercisesProcedure or surgery
Also called swallowing pathology therapy
Speech pathology therapy
| Study group | Role | What they receive |
|---|---|---|
| Speech pathology therapy | Experimental | Pre, during and pos-treatment swallowing exercises. Receives: Procedure: pre, during and pos-treatment swallowing exercises |
| Control group | No intervention | These patients will not receive speech pathology therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing function
Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).
Measured: up to 6 months after concurrent phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJul 2012
- Primary completionNov 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Neck 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André L Carvalho, PHD, Study chair, Fundação Pio XII - Hospital de Câncer de BarretosLuciano S Viana, PHD, Study director, Fundação Pio XII - Hospital de Câncer de BarretosAlexandre Jacinto, MD, Study director, Fundação Pio XII - Hospital de Câncer de BarretosJuliana Portas, MSC, Principal investigator, Fundação Pio XII - Hospital de Câncer de Barretos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075385
- Sponsor's protocol ID
- 589/2012
- Acronym
- Swallowing-1
- Status last verified
- Oct 2015
- First submitted
- 23 Jan 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02075385
- Acronym / sponsor ID
- Swallowing-1 / 589/2012
- Conditions
- Head Neck Cancer, Swallowing Disorders
- Keywords
- Dysphagia, speech language therapy, quality of life, induction chemotherapy, concurrent chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Mar 2014 (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.
General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy.
Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. Patients are randomized on two groups: control group and speech pathology therapy group
Detailed description
To evaluate and compare the swallowing and life quality swallowing on a group undergoing to speech pathology therapy (intervention) and a control group (no intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speech pathology therapy | Experimental | Procedure: pre, during and pos-treatment swallowing exercisesPre, during and pos-treatment swallowing exercises. |
| Control group | No intervention | –These patients will not receive speech pathology therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Head and neck squamous cell carcinoma
- Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy.
- Oropharynges, larynx and hypopharynx advanced cancer (T3 or T4), classified as resectable;
- 18 years old or older;
- informed consent signed before any specific procedure
Key exclusion criteria (5 listed)
- Previous head and neck surgery
- Previous radiotherapy or chemotherapy
- Previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma;
- Severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy
- Patients with cognitive deficit which could not comprehend the speech pathology intervention.
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 |
|---|---|---|
| pre, during and pos-treatment swallowing exercisesAlso: swallowing pathology therapySpeech pathology therapy | Procedure or surgery | Speech pathology therapy |
Primary outcome
Swallowing function
Time frame: up to 6 months after concurrent phase.
Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).
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 28 Jun 2017.
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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.
André L Carvalho, PHD study chair
Fundação Pio XII - Hospital de Câncer de Barretos
Luciano S Viana, PHD study director
Fundação Pio XII - Hospital de Câncer de Barretos
Alexandre Jacinto, MD study director
Fundação Pio XII - Hospital de Câncer de Barretos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pre, during and pos-treatment swallowing exercises in people with Head Neck Cancer and Swallowing Disorders, run by Barretos Cancer Hospital at 1 site in Brazil.
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 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: finished, as of the sponsor's last update on 28 Jun 2017. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Swallowing function (time frame: up to 6 months after concurrent phase.). 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 28 Jun 2017.