Deglutition DisordersdysphagiaNCT03755921
Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
A study testing bried and intensive therapy in people with Deglutition Disorders and Dysphagia, run by Federal University of Health Science of Porto Alegre.
Trial summary
According to data in the literature, patients with head and neck cancer, who undergo combined treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes. Most of the time, these patients undergo traditional speech-language interventions, performed weekly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Dysphagia, Head and Neck Cancer
- What is being tested?
- bried and intensive therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 30 Jan 2019
- 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
- Adult patients from 18 years of age;
- Diagnosis of head and neck cancer;
- Indication of combined treatment of radio-chemotherapy;
Who cannot join
- Have performed prior speech and hearing care for at least three months prior to the start of the study;
- Previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record;
- Cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to Brucki et al., 2003).
- Cardiac problems, according to the participant's report and information on the medical chart.
- Do not attend therapy for more than three sessions.
About this study
Official title: The Effects of Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
According to data in the literature, patients with head and neck cancer, who undergo combined treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes. Most of the time, these patients undergo traditional speech-language interventions, performed weekly. This project proposes a brief and intensive therapy program for dysphagia, with daily interventions, showing that this therapeutic modality generates benefits in a shorter time interval when compared to traditional therapy. This short service period contributes to the reduction of hospital costs and reduces the total number of interventions, which is beneficial for both the patient and the service that performs the care. The present study was to verify the efficacy of a brief and intensive therapy program for dysphagia in patients with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to a greater or lesser extent, changes of swallowing. This is a randomized clinical trial pilot project that will be developed in an oncology hospital. The population of this study is composed of patients diagnosed with head and neck cancer, over 18 years of age, with indication of combined radiotherapy , referred for speech therapy through the Multidisciplinary Oncology Outpatient Clinic of Santa Rita Hospital (AMOHR).
Read the detailed description
he sample will consist of 20 patients who will be randomized into two groups: 10 in the intervention group with intensive brief therapy and 10 in the control group with traditional weekly therapy. In both groups, instruments related to swallowing assessment and quality of life will be applied before and after speech therapy. The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs.
- Being tested
- bried and intensive therapy
- Medical subject headings
- Deglutition Disorders, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bried and intensive therapyOther
Speech Therapy Exercises
| Study group | Role | What they receive |
|---|---|---|
| Brief and intensive therapy | Experimental | exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily Receives: Other: bried and intensive therapy |
| Therapy Weekly | Active comparator | exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly Receives: Other: bried and intensive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
M. D. Anderson Dysphagia Inventory (MDADI)
41/5000 quality of life parameter, questionnaire.Questionnaire developed by Chen et al. (2001) and validated by Guedes et al. (2013) With the objective of evaluating the quality of life of patients. consisting of 20 items, involving global, physical, functional and emotional domains, with objective of assessing the impact of dysphagia on the quality of life of patients who underwent treatment of head and neck cancer
Measured: 3 months average
Secondary outcomes (3)
Functional Oral Intake Scale
oral intake, skale. It is composed by a seven-level scale, which graduates oral intake of patients.
Scale of seven levels, graduates the oral intake of patients. At level 1, the patient is exclusively using an alternative feeding route, with no oral conditions. At levels 2 and 3, it still depends on a consistency. At levels 4,5 and 6 it can be oral total in one of the most consistencies, with or without compensation, but with some restrictions. At level 7, the patient had total oral conditions, without restrictions.
Measured: 3 months average
Iowa Oral Performance Instrument (IOPI)
strength of language, assessment, equipment. Instrument developed in 1992, which allows to evaluate the strength and resistance of the tongue, by inserting a bulb into the oral cavity. The patient should lift the dorsum, and / or the anterior portion of the tongue against this bulb, pushing as hard as he can. Afterwards, the pressure transducer circuits of the apparatus will detect bulb compression, indicating the peak pressure result (Solomon et al, 2008; Robins et al, 2007).
Measured: 3 months average
Deglutition evaluation
evaluation of swallowing, protocol. In the structural evaluation (normal or altered), morphological (normal or altered) deglutitionstrength (normal or flaccid), mobility (normal or reduced), coordination (normal or altered) and sensitivity (normal or reduced), swallowing reflex (present or ausent), clinical signs suggestive of penetration / aspiration (present or ausent).
Measured: 3 months average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies 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
- Model description
- The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755921
- Sponsor's protocol ID
- TBI2018
- Acronym
- dysphagia
- Status last verified
- Nov 2018
- First submitted
- 9 Jul 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03755921
- Acronym / sponsor ID
- dysphagia / TBI2018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 28 Nov 2018 (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.
According to data in the literature, patients with head and neck cancer, who undergo combined treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes. Most of the time, these patients undergo traditional speech-language interventions, performed weekly. This project proposes a brief and intensive therapy program for dysphagia, with daily interventions, showing that this therapeutic modality generates benefits in a shorter time interval when compared to traditional therapy. This short service period contributes to the reduction of hospital costs and reduces the total number of interventions, which is beneficial for both the patient and the service that performs the care. The present study was to verify the efficacy of a brief and intensive therapy program for dysphagia in patients with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to a greater or lesser extent, changes of swallowing. This is a randomized clinical trial pilot project that will be developed in an oncology hospital. The population of this study is composed of patients diagnosed with head and neck cancer, over 18 years of age, with indication of combined radiotherapy , referred for speech therapy through the Multidisciplinary Oncology Outpatient Clinic of Santa Rita Hospital (AMOHR).
Detailed description
he sample will consist of 20 patients who will be randomized into two groups: 10 in the intervention group with intensive brief therapy and 10 in the control group with traditional weekly therapy. In both groups, instruments related to swallowing assessment and quality of life will be applied before and after speech therapy. The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs
| Arm | Type | Receives |
|---|---|---|
| Brief and intensive therapy | Experimental | Other: bried and intensive therapyexercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily |
| Therapy Weekly | Active comparator | Other: bried and intensive therapyexercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients from 18 years of age;
- Diagnosis of head and neck cancer;
- Indication of combined treatment of radio-chemotherapy;
Key exclusion criteria (5 listed)
- Have performed prior speech and hearing care for at least three months prior to the start of the study;
- Previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record;
- Cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to Brucki et al., 2003).
- Cardiac problems, according to the participant's report and information on the medical chart.
- Do not attend therapy for more than three sessions.
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 |
|---|---|---|
| bried and intensive therapySpeech Therapy Exercises | Other | Brief and intensive therapy, Therapy Weekly |
Primary outcome
M. D. Anderson Dysphagia Inventory (MDADI)
Time frame: 3 months average
41/5000 quality of life parameter, questionnaire.Questionnaire developed by Chen et al. (2001) and validated by Guedes et al. (2013) With the objective of evaluating the quality of life of patients. consisting of 20 items, involving global, physical, functional and emotional domains, with objective of assessing the impact of dysphagia on the quality of life of patients who underwent treatment of head and neck cancer
3 secondary outcomes
Functional Oral Intake Scale
Time frame: 3 months average
Iowa Oral Performance Instrument (IOPI)
Time frame: 3 months average
Deglutition evaluation
Time frame: 3 months average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing bried and intensive therapy in people with Deglutition Disorders and Dysphagia, run by Federal University of Health Science of Porto Alegre.
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 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 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
M. D. Anderson Dysphagia Inventory (MDADI) (time frame: 3 months average). 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 Nov 2018.