DysphagiaPRO-ACTIVENCT03455608
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
A study testing RE-ACTIVE, PRO-ACTIVE EAT and PRO-ACTIVE EAT + EXERCISE in people with Dysphagia, run by University Health Network, Toronto at 13 sites in 2 countries.
Trial summary
Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- RE-ACTIVE, PRO-ACTIVE EAT and PRO-ACTIVE EAT + EXERCISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 27 Sep 2018to 15 Nov 2024
- 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
- Adults ≥ 18 years of age diagnosed with head and neck malignancy;
- RT treatment planned for curative intent;
- Dispositioned to receive external beam radiotherapy dose ≥60 gray to bilateral fields at participating institution;
- Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires
Who cannot join
- Distant metastasis at enrollment; or
- Prior or planned total laryngectomy; or
- Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade ≥2 (as graded per central laboratory review)
- Previously seen by speech language pathologist for swallowing therapy for the current head and neck cancer
- Diagnosis of second primary non-head and neck cancers in the thorax or the central nervous system at enrollment
- Head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Boston University Medical Center
Boston, Massachusetts, 02118
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33146
Memorial Sloan Kettering Cancer Center
New York, New York, 10017
Orlando Health
Orlando, Florida, 32806
Canada3 sites
London Health Sciences Centre
London, Ontario
Jewish General Hospital
Montreal, Quebec, H3T 1E2
University Health Network
Toronto, Ontario, M5G 2M9
About this study
Official title: PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT.
Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective.
To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.
Read the detailed description
Swallowing therapy is commonly provided as a behavioral treatment to lessen the risk or severity of dysphagia in head and neck cancer (HNC) patients; however, best practice is not established. This multi-site, international randomized clinical trial (RCT) will compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing interventions in 952 HNC patients undergoing radiotherapy (RT). The 3 study arms represent alternate timing and intensity of swallowing therapy delivered by a speech language pathologist: 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, and 3) PRO-ACTIVE EAT + EXERCISE.
The primary aim of the PRO-ACTIVE trial is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with HNC planned to undergo RT. We hypothesize that the combined PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy; and, if so, that more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Effectiveness will be measured based on reduced duration of feeding tube dependency as the primary endpoint, an outcome valued equally by patients, caregivers and clinicians.
The secondary aim of the PRO-ACTIVE trial is to compare the relative benefit or harm of swallowing therapy arms on secondary outcomes including videofluoroscopic swallowing evaluations, functional status measures, health status measures, and patient-reported outcomes.
- Conditions
- Dysphagia
- Being tested
- RE-ACTIVE, PRO-ACTIVE EAT, PRO-ACTIVE EAT + EXERCISE
- Keywords
- dysphagia, swallowing disorder, speech pathology, swallowing therapy, head and neck cancer, radiotherapy, toxicity, supportive care
- 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.
RE-ACTIVEBehavioural
Reactive intervention started promptly if/when dysphagia is identified
PRO-ACTIVE EATBehavioural
Early low intensity proactive intervention started before RT commences
PRO-ACTIVE EAT + EXERCISEBehavioural
Early high intensity proactive intervention started before RT commences
| Study group | Role | What they receive |
|---|---|---|
| RE-ACTIVE | Active comparator | Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE) Receives: Behavioral: RE-ACTIVE |
| PRO-ACTIVE EAT | Active comparator | Early low intensity proactive intervention started before RT commences Receives: Behavioral: PRO-ACTIVE EAT |
| PRO-ACTIVE EAT + EXERCISE | Active comparator | Early high intensity proactive intervention started before RT commences Receives: Behavioral: PRO-ACTIVE EAT + EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of feeding tube dependence
Effectiveness will be measured based on duration of feeding tube dependency (count of days from end of radiotherapy to last feeding tube use within the 12-month study period)
Measured: Baseline - 12 months
Secondary outcomes (14)
The MD Anderson Dysphagia Inventory (MDADI)
Measurement of swallowing-related Quality of Life
Measured: Baseline, Week 6/7, 3 months, 12 months
The MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
Measurement of severity or burden of cancer-related symptoms and interference with daily functioning.
Measured: Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
Videofluoroscopy study score ranging from 0 to 5, where 4 is worst.
Measured: Baseline, 3 months, 12 months
Pharyngeal Constriction Ratio (PCR)
Videofluoroscopy study score ranging from 0 to 1, where 1 is worst.
Measured: Baseline, 3 months, 12 months
Penetration-Aspiration Scale (PAS)
Videofluoroscopy study score ranging from 1 to 8, where 8 is worst.
Measured: Baseline, 3 months, 12 months
Peak esophageal opening
Videofluoroscopy study score ranging from 0 to infinity, where lower value is worse.
Measured: Baseline, 3 months, 12 months
Performance Status Scale Head and Neck (PSS-HN)
Measurement of swallowing and speech performance
Measured: Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Medical Outcome of Dysphagia (MOD)
Patient reported symptoms related to health consequences secondary to dysphagia, namely: malnutrition, aspiration pneumonia and mood changes such as depression and anxiety
Measured: Baseline, 3 months, 12 months
Cancer Behavior Inventory (CBI-V3)
Measurement of self-efficacy strategies for coping with cancer
Measured: Baseline, 3 months, 12 months
EQ-5D-5L
Measurement of generic quality of life
Measured: Baseline, 3 months, 12 months
Medical History
Intake details, radiation therapy details, chemotherapy details, tumour status, surgery history, tracheotomy, feeding tube status, feeding tube dependence, concomitant therapies, and complication details.
Measured: Baseline, Week 6/7, 3 months, 12 months
Pain Medications
All pain medications (including over-the-counter) taken in the past 48 hours
Measured: Baseline; Week 6/7, 3 Month, and 12 Months
Mouth Opening/Trismus
Measurement of interincisal opening
Measured: Baseline; 3 Month and 12 Months
Hospitalization/Emergency Department (ED) Presentation
Hospitalization/ED presentation at cancer hospital or any external institutions
Measured: Baseline, Week 6/7, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start27 Sep 2018
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Applied Health Research Centre, Qualitative Health Research Consultants, LLC, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Rosemary Martino, PhD, Principal investigator, University Health Network, TorontoKate Hutcheson, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455608
- Sponsor's protocol ID
- CTO1363
- Acronym
- PRO-ACTIVE
- Status last verified
- Dec 2024
- First submitted
- 11 Feb 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krisciunas GP, Sokoloff W, Stepas K, Langmore SE. Survey of usual practice: dysphagia therapy in head and neck cancer patients. Dysphagia. 2012 Dec;27(4):538-49. doi: 10.1007/s00455-012-9404-2. Epub 2012 Mar 29.
PubMed 22456699Xu B, Boero IJ, Hwang L, Le QT, Moiseenko V, Sanghvi PR, Cohen EE, Mell LK, Murphy JD. Aspiration pneumonia after concurrent chemoradiotherapy for head and neck cancer. Cancer. 2015 Apr 15;121(8):1303-11. doi: 10.1002/cncr.29207. Epub 2014 Dec 23.
PubMed 25537836Hunter KU, Lee OE, Lyden TH, Haxer MJ, Feng FY, Schipper M, Worden F, Prince ME, McLean SA, Wolf GT, Bradford CR, Chepeha DB, Eisbruch A. Aspiration pneumonia after chemo-intensity-modulated radiation therapy of oropharyngeal carcinoma and its clinical and dysphagia-related predictors. Head Neck. 2014 Jan;36(1):120-5. doi: 10.1002/hed.23275. Epub 2013 Jun 1.
PubMed 23729173Hutcheson KA, Bhayani MK, Beadle BM, Gold KA, Shinn EH, Lai SY, Lewin J. Eat and exercise during radiotherapy or chemoradiotherapy for pharyngeal cancers: use it or lose it. JAMA Otolaryngol Head Neck Surg. 2013 Nov;139(11):1127-34. doi: 10.1001/jamaoto.2013.4715.
PubMed 24051544Setton J, Lee NY, Riaz N, Huang SH, Waldron J, O'Sullivan B, Zhang Z, Shi W, Rosenthal DI, Hutcheson KA, Garden AS. A multi-institution pooled analysis of gastrostomy tube dependence in patients with oropharyngeal cancer treated with definitive intensity-modulated radiotherapy. Cancer. 2015 Jan 15;121(2):294-301. doi: 10.1002/cncr.29022. Epub 2014 Oct 6.
PubMed 25286832Mortensen HR, Jensen K, Aksglaede K, Lambertsen K, Eriksen E, Grau C. Prophylactic Swallowing Exercises in Head and Neck Cancer Radiotherapy. Dysphagia. 2015 Jun;30(3):304-14. doi: 10.1007/s00455-015-9600-y. Epub 2015 Feb 19.
PubMed 25690840Ohba S, Yokoyama J, Kojima M, Fujimaki M, Anzai T, Komatsu H, Ikeda K. Significant preservation of swallowing function in chemoradiotherapy for advanced head and neck cancer by prophylactic swallowing exercise. Head Neck. 2016 Apr;38(4):517-21. doi: 10.1002/hed.23913. Epub 2015 Jun 16.
PubMed 25351675van der Molen L, van Rossum MA, Rasch CR, Smeele LE, Hilgers FJ. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer. Eur Arch Otorhinolaryngol. 2014 May;271(5):1257-70. doi: 10.1007/s00405-013-2640-8. Epub 2013 Jul 28.
PubMed 23892729Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008 Jan;118(1):39-43. doi: 10.1097/MLG.0b013e31815659b0.
PubMed 17989581Shaw SM, Flowers H, O'Sullivan B, Hope A, Liu LW, Martino R. The effect of prophylactic percutaneous endoscopic gastrostomy (PEG) tube placement on swallowing and swallow-related outcomes in patients undergoing radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2015 Apr;30(2):152-75. doi: 10.1007/s00455-014-9592-z. Epub 2015 Mar 4.
PubMed 25737196MD Anderson Head and Neck Cancer Symptom Working Group. Beyond mean pharyngeal constrictor dose for beam path toxicity in non-target swallowing muscles: Dose-volume correlates of chronic radiation-associated dysphagia (RAD) after oropharyngeal intensity modulated radiotherapy. Radiother Oncol. 2016 Feb;118(2):304-14. doi: 10.1016/j.radonc.2016.01.019. Epub 2016 Feb 17.
PubMed 26897515Eisbruch A, Kim HM, Feng FY, Lyden TH, Haxer MJ, Feng M, Worden FP, Bradford CR, Prince ME, Moyer JS, Wolf GT, Chepeha DB, Ten Haken RK. Chemo-IMRT of oropharyngeal cancer aiming to reduce dysphagia: swallowing organs late complication probabilities and dosimetric correlates. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e93-9. doi: 10.1016/j.ijrobp.2010.12.067. Epub 2011 May 17.
PubMed 21592678Hutcheson KA, Lewin JS, Barringer DA, Lisec A, Gunn GB, Moore MW, Holsinger FC. Late dysphagia after radiotherapy-based treatment of head and neck cancer. Cancer. 2012 Dec 1;118(23):5793-9. doi: 10.1002/cncr.27631. Epub 2012 May 17.
PubMed 23640737Rubin EB, Buehler AE, Halpern SD. States Worse Than Death Among Hospitalized Patients With Serious Illnesses. JAMA Intern Med. 2016 Oct 1;176(10):1557-1559. doi: 10.1001/jamainternmed.2016.4362. No abstract available.
PubMed 27479808Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
PubMed 26742998
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03455608
- Acronym / sponsor ID
- PRO-ACTIVE / CTO1363
- Conditions
- Dysphagia
- Keywords
- dysphagia, swallowing disorder, speech pathology, swallowing therapy, head and neck cancer, radiotherapy, toxicity, supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Applied Health Research Centre, Qualitative Health Research Consultants, LLC, Patient-Centered Outcomes Research Institute
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 6 Mar 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.
Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT.
Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective.
To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.
Detailed description
Swallowing therapy is commonly provided as a behavioral treatment to lessen the risk or severity of dysphagia in head and neck cancer (HNC) patients; however, best practice is not established. This multi-site, international randomized clinical trial (RCT) will compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing interventions in 952 HNC patients undergoing radiotherapy (RT). The 3 study arms represent alternate timing and intensity of swallowing therapy delivered by a speech language pathologist: 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, and 3) PRO-ACTIVE EAT + EXERCISE.
The primary aim of the PRO-ACTIVE trial is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with HNC planned to undergo RT. We hypothesize that the combined PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy; and, if so, that more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Effectiveness will be measured based on reduced duration of feeding tube dependency as the primary endpoint, an outcome valued equally by patients, caregivers and clinicians.
The secondary aim of the PRO-ACTIVE trial is to compare the relative benefit or harm of swallowing therapy arms on secondary outcomes including videofluoroscopic swallowing evaluations, functional status measures, health status measures, and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RE-ACTIVE | Active comparator | Behavioral: RE-ACTIVEReactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE) |
| PRO-ACTIVE EAT | Active comparator | Behavioral: PRO-ACTIVE EATEarly low intensity proactive intervention started before RT commences |
| PRO-ACTIVE EAT + EXERCISE | Active comparator | Behavioral: PRO-ACTIVE EAT + EXERCISEEarly high intensity proactive intervention started before RT commences |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years of age diagnosed with head and neck malignancy;
- RT treatment planned for curative intent;
- Dispositioned to receive external beam radiotherapy dose ≥60 gray to bilateral fields at participating institution;
- Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires
Key exclusion criteria (6 listed)
- Distant metastasis at enrollment; or
- Prior or planned total laryngectomy; or
- Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade ≥2 (as graded per central laboratory review)
- Previously seen by speech language pathologist for swallowing therapy for the current head and neck cancer
- Diagnosis of second primary non-head and neck cancers in the thorax or the central nervous system at enrollment
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 |
|---|---|---|
| RE-ACTIVEReactive intervention started promptly if/when dysphagia is identified | Behavioural | RE-ACTIVE |
| PRO-ACTIVE EATEarly low intensity proactive intervention started before RT commences | Behavioural | PRO-ACTIVE EAT |
| PRO-ACTIVE EAT + EXERCISEEarly high intensity proactive intervention started before RT commences | Behavioural | PRO-ACTIVE EAT + EXERCISE |
Primary outcome
Duration of feeding tube dependence
Time frame: Baseline - 12 months
Effectiveness will be measured based on duration of feeding tube dependency (count of days from end of radiotherapy to last feeding tube use within the 12-month study period)
14 secondary outcomes
The MD Anderson Dysphagia Inventory (MDADI)
Time frame: Baseline, Week 6/7, 3 months, 12 months
The MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
Time frame: Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
Time frame: Baseline, 3 months, 12 months
Pharyngeal Constriction Ratio (PCR)
Time frame: Baseline, 3 months, 12 months
Penetration-Aspiration Scale (PAS)
Time frame: Baseline, 3 months, 12 months
Peak esophageal opening
Time frame: Baseline, 3 months, 12 months
Performance Status Scale Head and Neck (PSS-HN)
Time frame: Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Medical Outcome of Dysphagia (MOD)
Time frame: Baseline, 3 months, 12 months
Cancer Behavior Inventory (CBI-V3)
Time frame: Baseline, 3 months, 12 months
EQ-5D-5L
Time frame: Baseline, 3 months, 12 months
Medical History
Time frame: Baseline, Week 6/7, 3 months, 12 months
Pain Medications
Time frame: Baseline; Week 6/7, 3 Month, and 12 Months
Mouth Opening/Trismus
Time frame: Baseline; 3 Month and 12 Months
Hospitalization/Emergency Department (ED) Presentation
Time frame: Baseline, Week 6/7, 3 months, 12 months
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 10 Dec 2024.
- Background: PubMed 22456699Krisciunas GP, Sokoloff W, Stepas K, Langmore SE. Survey of usual practice: dysphagia therapy in head and neck cancer patients. Dysphagia. 2012 Dec;27(4):538-49. doi: 10.1007/s00455-012-9404-2. Epub 2012 Mar 29.
- Background: PubMed 25537836Xu B, Boero IJ, Hwang L, Le QT, Moiseenko V, Sanghvi PR, Cohen EE, Mell LK, Murphy JD. Aspiration pneumonia after concurrent chemoradiotherapy for head and neck cancer. Cancer. 2015 Apr 15;121(8):1303-11. doi: 10.1002/cncr.29207. Epub 2014 Dec 23.
- Background: PubMed 23729173Hunter KU, Lee OE, Lyden TH, Haxer MJ, Feng FY, Schipper M, Worden F, Prince ME, McLean SA, Wolf GT, Bradford CR, Chepeha DB, Eisbruch A. Aspiration pneumonia after chemo-intensity-modulated radiation therapy of oropharyngeal carcinoma and its clinical and dysphagia-related predictors. Head Neck. 2014 Jan;36(1):120-5. doi: 10.1002/hed.23275. Epub 2013 Jun 1.
- Background: PubMed 24051544Hutcheson KA, Bhayani MK, Beadle BM, Gold KA, Shinn EH, Lai SY, Lewin J. Eat and exercise during radiotherapy or chemoradiotherapy for pharyngeal cancers: use it or lose it. JAMA Otolaryngol Head Neck Surg. 2013 Nov;139(11):1127-34. doi: 10.1001/jamaoto.2013.4715.
- Background: PubMed 25286832Setton J, Lee NY, Riaz N, Huang SH, Waldron J, O'Sullivan B, Zhang Z, Shi W, Rosenthal DI, Hutcheson KA, Garden AS. A multi-institution pooled analysis of gastrostomy tube dependence in patients with oropharyngeal cancer treated with definitive intensity-modulated radiotherapy. Cancer. 2015 Jan 15;121(2):294-301. doi: 10.1002/cncr.29022. Epub 2014 Oct 6.
- Background: PubMed 25690840Mortensen HR, Jensen K, Aksglaede K, Lambertsen K, Eriksen E, Grau C. Prophylactic Swallowing Exercises in Head and Neck Cancer Radiotherapy. Dysphagia. 2015 Jun;30(3):304-14. doi: 10.1007/s00455-015-9600-y. Epub 2015 Feb 19.
- Background: PubMed 25351675Ohba S, Yokoyama J, Kojima M, Fujimaki M, Anzai T, Komatsu H, Ikeda K. Significant preservation of swallowing function in chemoradiotherapy for advanced head and neck cancer by prophylactic swallowing exercise. Head Neck. 2016 Apr;38(4):517-21. doi: 10.1002/hed.23913. Epub 2015 Jun 16.
- Background: PubMed 23892729van der Molen L, van Rossum MA, Rasch CR, Smeele LE, Hilgers FJ. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer. Eur Arch Otorhinolaryngol. 2014 May;271(5):1257-70. doi: 10.1007/s00405-013-2640-8. Epub 2013 Jul 28.
- Background: PubMed 17989581Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008 Jan;118(1):39-43. doi: 10.1097/MLG.0b013e31815659b0.
- Background: PubMed 25737196Shaw SM, Flowers H, O'Sullivan B, Hope A, Liu LW, Martino R. The effect of prophylactic percutaneous endoscopic gastrostomy (PEG) tube placement on swallowing and swallow-related outcomes in patients undergoing radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2015 Apr;30(2):152-75. doi: 10.1007/s00455-014-9592-z. Epub 2015 Mar 4.
- Background: PubMed 26897515MD Anderson Head and Neck Cancer Symptom Working Group. Beyond mean pharyngeal constrictor dose for beam path toxicity in non-target swallowing muscles: Dose-volume correlates of chronic radiation-associated dysphagia (RAD) after oropharyngeal intensity modulated radiotherapy. Radiother Oncol. 2016 Feb;118(2):304-14. doi: 10.1016/j.radonc.2016.01.019. Epub 2016 Feb 17.
- Background: PubMed 21592678Eisbruch A, Kim HM, Feng FY, Lyden TH, Haxer MJ, Feng M, Worden FP, Bradford CR, Prince ME, Moyer JS, Wolf GT, Chepeha DB, Ten Haken RK. Chemo-IMRT of oropharyngeal cancer aiming to reduce dysphagia: swallowing organs late complication probabilities and dosimetric correlates. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e93-9. doi: 10.1016/j.ijrobp.2010.12.067. Epub 2011 May 17.
- Individual participant dataSharing planned: No
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Dysphagia
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.
Rosemary Martino, PhD principal investigator
University Health Network, Toronto
Kate Hutcheson, PhD principal investigator
M.D. Anderson Cancer Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RE-ACTIVE, PRO-ACTIVE EAT and PRO-ACTIVE EAT + EXERCISE in people with Dysphagia, run by University Health Network, Toronto at 13 sites in 2 countries.
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 6 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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?
Duration of feeding tube dependence (time frame: Baseline - 12 months). 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 NCT03455608, which also lists 31 linked publications.
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 10 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.