Head and Neck CancerPhase 3NCT00003610
Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy
A Phase 3 study testing capsaicin and radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Alliance for Clinical Trials in Oncology at 17 sites in United States.
Trial summary
RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment for mucositis caused by radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiation Toxicity
- What is being tested?
- capsaicin and radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 1998to Jul 2006
- 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: Scheduled to receive radiation treatment to at least one third of the oral cavity at a total dose of at least 5000 cGy using 200 cGy/fraction Must be entered on study within first 3 days of radiation No open mouth sores at study entry
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known intolerance to capsaicin No allergy to citric acid, cherry flavorings, or FC and C red dye #3 or #40
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the oral mucosa Surgery: Not specified Other: No requirement for tube feeding
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, 58501
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 10309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
Altru Health Systems
Grand Forks, North Dakota, 58201
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CentraCare Clinic
Saint Cloud, Minnesota, 56303
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis
RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment for mucositis caused by radiation therapy.
PURPOSE: Randomized phase III trial to study the effectiveness of capsaicin lozenges in treating patients with mucositis caused by radiation therapy.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of capsaicin lozenges in terms of frequency, duration, and severity of mouth pain caused by radiation therapy to the oral cavity. II. Evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified according to dentures (yes vs no), smoking history (none vs currently vs past only), radiation therapy (primary vs postoperative adjuvant), planned radiation dose (5000-6000 cGy vs greater than 6000 cGy), planned fluoride use (yes vs no), and amount of oral mucosa in radiation field (one- to two-thirds vs greater than two-thirds). Patients receive one lozenge orally of capsaicin or placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.
- Conditions
- Head and Neck Cancer, Radiation Toxicity
- Being tested
- capsaicin, placebo, radiation therapy
- Medical subject headings
- 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.
capsaicinDietary supplement
placeboOther
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| capsaicin + radiation therapy | Experimental | Patients receive one lozenge orally of capsaicin four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed. Receives: Dietary Supplement: capsaicin; Radiation: radiation therapy |
| placebo + radiation therapy | Placebo comparator | Patients receive one lozenge orally of placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed. Receives: Other: placebo; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of mouth pain
Measured: Up to 2 weeks post-radiation treatment
duration of mouth pain
Measured: Up to 2 weeks post-radiation treatment
severity of mouth pain
Measured: Up to 2 weeks post-radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startOct 1998
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- 18 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
- Scott Okuno, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003610
- Sponsor's protocol ID
- NCCTG-969257
- Other IDs
- CDR0000066687, NCI-P98-0136
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis
- ClinicalTrials.gov ID
- NCT00003610
- Acronym / sponsor ID
- NCCTG-969257
- Conditions
- Head and Neck Cancer, Radiation Toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1998
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Jul 2004 (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: Capsaicin lozenges may be effective treatment for mucositis caused by radiation therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment for mucositis caused by radiation therapy.
PURPOSE: Randomized phase III trial to study the effectiveness of capsaicin lozenges in treating patients with mucositis caused by radiation therapy.
Detailed description
OBJECTIVES: I. Determine the efficacy of capsaicin lozenges in terms of frequency, duration, and severity of mouth pain caused by radiation therapy to the oral cavity. II. Evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified according to dentures (yes vs no), smoking history (none vs currently vs past only), radiation therapy (primary vs postoperative adjuvant), planned radiation dose (5000-6000 cGy vs greater than 6000 cGy), planned fluoride use (yes vs no), and amount of oral mucosa in radiation field (one- to two-thirds vs greater than two-thirds). Patients receive one lozenge orally of capsaicin or placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capsaicin + radiation therapy | Experimental | Dietary Supplement: capsaicin, Radiation: radiation therapyPatients receive one lozenge orally of capsaicin four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed. |
| placebo + radiation therapy | Placebo comparator | Other: placebo, Radiation: radiation therapyPatients receive one lozenge orally of placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed. |
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 |
|---|---|---|
| capsaicin | Dietary supplement | capsaicin + radiation therapy |
| placebo | Other | placebo + radiation therapy |
| radiation therapy | Radiation | capsaicin + radiation therapy, placebo + radiation therapy |
Primary outcome
frequency of mouth pain
Time frame: Up to 2 weeks post-radiation treatment
duration of mouth pain
Time frame: Up to 2 weeks post-radiation treatment
severity of mouth pain
Time frame: Up to 2 weeks post-radiation treatment
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 13 Jul 2016.
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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.
Scott Okuno, MD study chair
Mayo Clinic
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing capsaicin and radiation therapy in people with Head and Neck Cancer and Radiation Toxicity, run by Alliance for Clinical Trials in Oncology at 17 sites 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?
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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. 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?
frequency of mouth pain (time frame: Up to 2 weeks post-radiation treatment). The study lists 3 primary outcomes in all. 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 13 Jul 2016.