DysgeusiaPhase 3NCT00036881
Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer
A Phase 3 study testing zinc sulfate in people with Dysgeusia and Head and Neck Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysgeusia, Head and Neck Cancer, Oral Complications
- What is being tested?
- zinc sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jun 2007
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of head and neck cancer
- No stage I laryngeal cancer
- Planned treatment with at least 2,000 cGy of external beam radiotherapy to at least 30% of the oral cavity
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Gastrointestinal:
- Able to tolerate oral medication
- No known mechanical obstruction of the alimentary tract
- No malabsorption
- No intractable vomiting (more than 5 episodes per week)
Other:
- No known intolerance to zinc sulfate
- No known, untreated oral thrush
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Surgery:
- No prior surgery that included ablation or removal of the olfactory component of taste
Other:
- No concurrent zinc supplements
- Concurrent standard multivitamins allowed
About this study
Official title: Phase III Double-Blind, Placebo-Controlled Randomized Comparison Of Zinc Sulfate Versus Placebo For The Prevention Of Altered Taste In Patients With Head And Neck Cancer During Radiation
RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer.
Read the detailed description
OBJECTIVES:
- Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy.
- Determine whether this drug decreases the overall incidence of altered taste in these patients.
- Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients.
- Assess the quality of life of patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to planned radiotherapy dose (less than 6,000 cGy vs at least 6,000 cGy), estimated amount of oral mucosa in the radiation field (60% or less vs more than 60%), age (under 50 vs 50 and over), concurrent chemotherapy (yes vs no), and smoking (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy.
- Arm II: Patients receive oral placebo 3 times daily beginning the first week of radiotherapy.
Treatment in both arms continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment.
Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.
- Being tested
- zinc sulfate, placebo
- Medical subject headings
- Dysgeusia, Head and Neck Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulfateDietary supplement
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| zinc sulfate | Experimental | Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy.
Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment.
Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year. Receives: Dietary Supplement: zinc sulfate |
| placebo | Placebo comparator | Patients receive oral placebo 3 times daily beginning the first week of radiotherapy.
Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment.
Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of the time to onset of altered taste by zinc sulfate
Measured: Up to 1.5 years
Secondary outcomes (1)
Incidence of taste alteration
Measured: Up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionApr 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysgeusiaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036881
- Sponsor's protocol ID
- NCCTG-N01C4
- Other IDs
- NCI-2012-02465, NCI-P02-0224, CDR0000069337
- Status last verified
- Jul 2016
- First submitted
- 13 May 2002
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046.
PubMed 17394940
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Double-Blind, Placebo-Controlled Randomized Comparison Of Zinc Sulfate Versus Placebo For The Prevention Of Altered Taste In Patients With Head And Neck Cancer During Radiation
- ClinicalTrials.gov ID
- NCT00036881
- Acronym / sponsor ID
- NCCTG-N01C4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer.
Detailed description
OBJECTIVES:
- Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy.
- Determine whether this drug decreases the overall incidence of altered taste in these patients.
- Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients.
- Assess the quality of life of patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to planned radiotherapy dose (less than 6,000 cGy vs at least 6,000 cGy), estimated amount of oral mucosa in the radiation field (60% or less vs more than 60%), age (under 50 vs 50 and over), concurrent chemotherapy (yes vs no), and smoking (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy.
- Arm II: Patients receive oral placebo 3 times daily beginning the first week of radiotherapy.
Treatment in both arms continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment.
Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc sulfate | Experimental | Dietary Supplement: zinc sulfatePatients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy. Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year. |
| placebo | Placebo comparator | Other: placeboPatients receive oral placebo 3 times daily beginning the first week of radiotherapy. Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| zinc sulfate | Dietary supplement | zinc sulfate |
| placebo | Other | placebo |
Primary outcome
Prolongation of the time to onset of altered taste by zinc sulfate
Time frame: Up to 1.5 years
1 secondary outcome
Incidence of taste alteration
Time frame: Up to 1.5 years
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 14 Jul 2016.
- Results publication: PubMed 17394940Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046.
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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.
Aminah Jatoi, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zinc sulfate in people with Dysgeusia and Head and Neck Cancer, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Jul 2016. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Prolongation of the time to onset of altered taste by zinc sulfate (time frame: Up to 1.5 years). 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 NCT00036881, which also lists 1 linked publication.
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 14 Jul 2016.