DysphagiaPhase 2NCT00503776
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
A Phase 2 study testing exercise intervention, amifostine trihydrate and therapeutic dietary intervention in people with Dysphagia and Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dysphagia, Head and Neck Cancer, Mucositis
- What is being tested?
- exercise intervention, amifostine trihydrate and therapeutic dietary intervention
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2008
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 21
- Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity or salivary glands
- No prior history of active cancer within three years other than non-melanoma skin cancer, early stage prostate or early stage cervical cancer
- controlled co-morbid disease
- ECOG PS of 0-3
- Plan for definitive or post-operative CCR within 4 weeks
Show all 10Show fewer
- Written informed consent
- Working telephone
- May have received prior induction chemotherapy
- Agree to use only study supplied liquid nutrition supplements or dietary supplements, for per os or feeding tube intake
Who cannot join
- Diagnosed HIV or AIDS
- History of ETOH or drug abuse within 3 months
- Pregnant or lactating
- On steroid medication or prescribed NSAIDs
- Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)
- On orexigenic (appetite stimulant) medication.
- Uncontrolled comorbid disease defined as: a) severe cardiac disease Class III or greater; b) blood pressure > 160/95; c) uncontrolled pain
- Does not have working telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.
PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
- To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status
OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.
Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard of care): Patients are further divided into 1A or 1B.
- Arm IA: Standard of care plus standardized nutrition therapy (SNT)
- Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT).
- Arm II (amifostine): Patients are further divided into 2A or 2B.
- Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
- Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training
In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.
Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry.
After completion of study treatment, patients are followed at 1, 3, and 6 months.
- Conditions
- Dysphagia, Head and Neck Cancer, Mucositis, Xerostomia
- Being tested
- exercise intervention, amifostine trihydrate, therapeutic dietary intervention
- Keywords
- xerostomia, mucositis, dysphagia, radiation toxicity, chemotherapeutic agent toxicity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV verrucous carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent verrucous carcinoma of the oral cavity
- Medical subject headings
- Deglutition Disorders, Head and Neck Neoplasms, Mucositis, Xerostomia, Radiation Injuries, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Patients undergo low weight resistance training.
amifostine trihydrateDrug
Also called Ethyol
Given subcutaneously
therapeutic dietary interventionProcedure or surgery
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
| Study group | Role | What they receive |
|---|---|---|
| Arm IA | Active comparator | Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. Receives: Procedure: therapeutic dietary intervention |
| Arm IB | Active comparator | Patients undergo SNT and low weight resistance training (LWRT). Receives: Behavioral: exercise intervention; Procedure: therapeutic dietary intervention |
| Arm IIA | Experimental | Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA. Receives: Drug: amifostine trihydrate; Procedure: therapeutic dietary intervention |
| Arm IIB | Experimental | Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB. Receives: Behavioral: exercise intervention; Drug: amifostine trihydrate; Procedure: therapeutic dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Each Degree of Swallowing Dysfunction
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
Measured: 6 months after concurrent chemotherapy and radiation
Secondary outcomes (4)
Stimulated and Unstimulated Salivary Production
Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.
Measured: 6 months after concurrent chemotherapy and radiation
Number of Patients With Oral Mucositis by Grade
Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).
Measured: 6 months after concurrent chemotherapy and radiation
Changes in the Amount and Texture of Food Consumed
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.
Measured: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Changes in the Frequency and Types of Dietary Intakes
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.
Measured: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJan 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: funding became unavailable
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 DysphagiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara A. Murphy, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503776
- Sponsor's protocol ID
- VICC HN 0554
- Other IDs
- VU-VICC-HN-0554, VU-VICC-IRB-051068
- Status last verified
- May 2017
- First submitted
- 17 Jul 2007
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
- ClinicalTrials.gov ID
- NCT00503776
- Acronym / sponsor ID
- VICC HN 0554
- Conditions
- Dysphagia, Head and Neck Cancer, Mucositis, Xerostomia
- Keywords
- xerostomia, mucositis, dysphagia, radiation toxicity, chemotherapeutic agent toxicity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding became unavailable
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 8 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.
PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
- To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status
OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.
Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard of care): Patients are further divided into 1A or 1B.
- Arm IA: Standard of care plus standardized nutrition therapy (SNT)
- Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT).
- Arm II (amifostine): Patients are further divided into 2A or 2B.
- Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
- Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training
In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.
Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry.
After completion of study treatment, patients are followed at 1, 3, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm IA | Active comparator | Procedure: therapeutic dietary interventionPatients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. |
| Arm IB | Active comparator | Behavioral: exercise intervention, Procedure: therapeutic dietary interventionPatients undergo SNT and low weight resistance training (LWRT). |
| Arm IIA | Experimental | Drug: amifostine trihydrate, Procedure: therapeutic dietary interventionPatients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA. |
| Arm IIB | Experimental | Behavioral: exercise intervention, Drug: amifostine trihydrate, Procedure: therapeutic dietary interventionPatients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than 21
- Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity or salivary glands
- No prior history of active cancer within three years other than non-melanoma skin cancer, early stage prostate or early stage cervical cancer
- controlled co-morbid disease
- ECOG PS of 0-3
Key exclusion criteria (8 listed)
- Diagnosed HIV or AIDS
- History of ETOH or drug abuse within 3 months
- Pregnant or lactating
- On steroid medication or prescribed NSAIDs
- Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)
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 |
|---|---|---|
| exercise interventionPatients undergo low weight resistance training. | Behavioural | Arm IB, Arm IIB |
| amifostine trihydrateAlso: EthyolGiven subcutaneously | Drug | Arm IIA, Arm IIB |
| therapeutic dietary interventionPatients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. | Procedure or surgery | Arm IA, Arm IB, Arm IIA, Arm IIB |
Primary outcome
Number of Patients With Each Degree of Swallowing Dysfunction
Time frame: 6 months after concurrent chemotherapy and radiation
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
4 secondary outcomes
Stimulated and Unstimulated Salivary Production
Time frame: 6 months after concurrent chemotherapy and radiation
Number of Patients With Oral Mucositis by Grade
Time frame: 6 months after concurrent chemotherapy and radiation
Changes in the Amount and Texture of Food Consumed
Time frame: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Changes in the Frequency and Types of Dietary Intakes
Time frame: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Barbara A. Murphy, MD study chair
Vanderbilt-Ingram Cancer Center
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 exercise intervention, amifostine trihydrate and therapeutic dietary intervention in people with Dysphagia and Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site 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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 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 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.
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?
Yes. Results are posted in the registry (first posted 8 Dec 2011). 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?
Number of Patients With Each Degree of Swallowing Dysfunction (time frame: 6 months after concurrent chemotherapy and radiation). 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 Jun 2017.