Oropharynx CancerPhase 3NCT01066741

Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer

A Phase 3 study testing Homeodent® and 1.4% Sodium Bicarbonate solution in people with Oropharynx Cancer and Hypopharynx Cancer, run by Centre Leon Berard at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Oropharynx Cancer, Hypopharynx Cancer
What is being tested?: Homeodent® and 1.4% Sodium Bicarbonate solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteFrance
Study dates: May 2009to Aug 2011
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patient aged ≥ 18 years
ECOG PS ≤ 2
Patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid carcinoma, whatever the stage
Patient receiving a minimum radiation dose of 60 Gy
Planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx
Mandatory affiliation with a health insurance system
Signed, written informed consent

Who cannot join

Previous irradiation to the oral mucosa and/or oropharynx
Pre-existing mucositis
Pregnant or lactating woman (negative serum or urinary pregnancy test for women with child-bearing potential)
Patient included in another study including experimental radiotherapy possibly toxic to the mucosa
difficult follow up of the patient
patient deprived of civil rights

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Léon Bérard
Lyon

Other trials in France

About this study

Official title: Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer

This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

Read the detailed description

The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. However, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. The treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. This study will evaluate the efficiency of mouthwash with Homeodent® in a large randomized trial.

Conditions: Oropharynx Cancer, Hypopharynx Cancer
Being tested: Homeodent®, 1.4% Sodium Bicarbonate solution
Keywords: Epidermoid carcinoma, Hypopharynx, Oropharynx, Oral cavity, Oral mucosa, Cavum, Severe Oral mucositis, Radiotherapy, Phytotherapy
Medical subject headings: Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Carcinoma, Squamous Cell, Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Homeodent®Drug
Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.
1.4% Sodium Bicarbonate solutionDrug
Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing

Study groups in NCT01066741
Study group	Role	What they receive
Homeodent®	Experimental	Mouthwash with Homeodent® is started on the first day of irradiation, then continued until the end of the irradiation period or until occurrence of grade ≥3 mucositis. In case of grade ≥3 mucositis, patients are instructed to mouthwash with Sodium Bicarbonate solution until complete disappearance of mucositis or until the end of irradiation. Receives: Drug: Homeodent®
1.4 % Sodium Bicarbonate solution	Active comparator	Mouthwash with sodium bicarbonate is started on the first day of irradiation, then continued until the end of the irradiation period. In case of grade ≥3 mucositis, mouthwash is continued until complete disappearance of the mucositis or until the end of irradiation. In both arms, after the end of irradiation, patients can receive treatment with Sodium Bicarbonate solution until complete disappearance of the mucositis. Receives: Drug: 1.4% Sodium Bicarbonate solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported)
Measured: At the end of irradiation period (6 weeks)

Secondary outcomes (9)

Rate of grade ≥2 mucositis
Measured: At the end of irradiation period (6 weeks)
Rate of Mycosis and Herpes virus infection
Measured: At the end of irradiation period (6 weeks)
Rate of use of symptomatic treatment in case of occurrence of mucositis
Measured: At the end of irradiation period (6 weeks)
Rate and duration of radiation treatment interruption for toxicity
Measured: At the end of irradiation period (6 weeks)
radiation dose, duration of grade ≥3 mucositis, maximum weight loss and maximum level of oral pain in case of grade ≥3 mucositis.
Measured: during the occurence of grade≥3 mucositis
Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance
Measured: during medication administration
Nutritional intake, estimated using caloric intake and the Detsky score, and rate of enteral and/or parenteral nutrition, in case of toxicity during irradiation
Measured: during the period of toxicity
Rate of agreement between the radiation oncologist and the stomatologist for the detection of Grade ≥2 (RTOG classification) mucositis
Measured: At the end of irradiation period (6 weeks)
Evaluation of the cost of severe mucositis treatment
Measured: during and until the end of severe mucositis treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Aug 2011

First posted10 Feb 2010 (estimated)
Study startMay 2009
Primary completionFeb 2011
Study completionAug 2011

Why it stopped: insufficient recruitment, the planed sample size appears not achievable

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Oropharynx CancerStudies of the same condition, open and under way.
More trials run by Centre Leon BerardThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01066741
Sponsor's protocol ID: HOMEODENT
Other IDs: ET2006-042
Status last verified: Oct 2012
First submitted: 5 Feb 2010
Last updated: 1 Nov 2012
Results posted: No
Data monitoring committee: No

Publications

Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.
PubMed 12742264
Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy: part 1, pathogenesis and prophylaxis of mucositis. Head Neck. 2003 Dec;25(12):1057-70. doi: 10.1002/hed.10318.
PubMed 14648865
Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
PubMed 15782422
Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy. Part 2: diagnosis and management of mucositis. Head Neck. 2004 Jan;26(1):77-84. doi: 10.1002/hed.10326.
PubMed 14724910
Lapeyre M, Charra-Brunaud C, Kaminsky MC, Geoffrois L, Dolivet G, Toussaint B, Maire F, Pourel N, Simon M, Marchal C, Bey P. [Management of mucositis following radiotherapy for head and neck cancers]. Cancer Radiother. 2001 Nov;5 Suppl 1:121s-130s. French.
PubMed 11797271
Worthington HV, Clarkson JE, Eden OB. Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2004;(2):CD001973. doi: 10.1002/14651858.CD001973.pub2.
PubMed 15106165
Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD000978. doi: 10.1002/14651858.CD000978.pub2.
PubMed 16625538
Trotti A, Garden A, Warde P, Symonds P, Langer C, Redman R, Pajak TF, Fleming TR, Henke M, Bourhis J, Rosenthal DI, Junor E, Cmelak A, Sheehan F, Pulliam J, Devitt-Risse P, Fuchs H, Chambers M, O'Sullivan B, Ang KK. A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):674-81. doi: 10.1016/S0360-3016(03)01627-4.
PubMed 14967419
El-Sayed S, Nabid A, Shelley W, Hay J, Balogh J, Gelinas M, MacKenzie R, Read N, Berthelet E, Lau H, Epstein J, Delvecchio P, Ganguly PK, Wong F, Burns P, Tu D, Pater J. Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system. J Clin Oncol. 2002 Oct 1;20(19):3956-63. doi: 10.1200/JCO.2002.05.046.
PubMed 12351592
Dodd MJ, Miaskowski C, Greenspan D, MacPhail L, Shih AS, Shiba G, Facione N, Paul SM. Radiation-induced mucositis: a randomized clinical trial of micronized sucralfate versus salt & soda mouthwashes. Cancer Invest. 2003;21(1):21-33. doi: 10.1081/cnv-120016400.
PubMed 12643006
Stokman MA, Spijkervet FK, Burlage FR, Dijkstra PU, Manson WL, de Vries EG, Roodenburg JL. Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial. Br J Cancer. 2003 Apr 7;88(7):1012-6. doi: 10.1038/sj.bjc.6600824.
PubMed 12671696
Saarilahti K, Kajanti M, Joensuu T, Kouri M, Joensuu H. Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):479-85. doi: 10.1016/s0360-3016(02)02935-8.
PubMed 12243825
Warde P, O'Sullivan B, Aslanidis J, Kroll B, Lockwood G, Waldron J, Payne D, Bayley A, Ringash J, Kim J, Liu FF, Maxymiw W, Sprague S, Cummings BJ. A Phase III placebo-controlled trial of oral pilocarpine in patients undergoing radiotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):9-13. doi: 10.1016/s0360-3016(02)02890-0.
PubMed 12182969
Epstein JB, Silverman S Jr, Paggiarino DA, Crockett S, Schubert MM, Senzer NN, Lockhart PB, Gallagher MJ, Peterson DE, Leveque FG. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001 Aug 15;92(4):875-85. doi: 10.1002/1097-0142(20010815)92:43.0.co;2-1.
PubMed 11550161
Ertekin MV, Koc M, Karslioglu I, Sezen O. Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study. Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):167-74. doi: 10.1016/s0360-3016(03)01562-1.
PubMed 14697435

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer
ClinicalTrials.gov ID: NCT01066741
Acronym / sponsor ID: HOMEODENT
Conditions: Oropharynx Cancer, Hypopharynx Cancer
Keywords: Epidermoid carcinoma, Hypopharynx, Oropharynx, Oral cavity, Oral mucosa, Cavum, Severe Oral mucositis, Radiotherapy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: insufficient recruitment, the planed sample size appears not achievable
Enrolment: 78 participants (actual)
Lead sponsor: Centre Leon BerardUniversity, hospital or other
Collaborators: BOIRON
Study start: May 2009
Primary completion: Feb 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 10 Feb 2010 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Homeodent®	Experimental	Drug: Homeodent®Mouthwash with Homeodent® is started on the first day of irradiation, then continued until the end of the irradiation period or until occurrence of grade ≥3 mucositis. In case of grade ≥3 mucositis, patients are instructed to mouthwash with Sodium Bicarbonate solution until complete disappearance of mucositis or until the end of irradiation.
1.4 % Sodium Bicarbonate solution	Active comparator	Drug: 1.4% Sodium Bicarbonate solutionMouthwash with sodium bicarbonate is started on the first day of irradiation, then continued until the end of the irradiation period. In case of grade ≥3 mucositis, mouthwash is continued until complete disappearance of the mucositis or until the end of irradiation. In both arms, after the end of irradiation, patients can receive treatment with Sodium Bicarbonate solution until complete disappearance of the mucositis.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female patient aged ≥ 18 years
ECOG PS ≤ 2
Patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid carcinoma, whatever the stage
Patient receiving a minimum radiation dose of 60 Gy
Planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx

Key exclusion criteria (6 listed)

Previous irradiation to the oral mucosa and/or oropharynx
Pre-existing mucositis
Pregnant or lactating woman (negative serum or urinary pregnancy test for women with child-bearing potential)
Patient included in another study including experimental radiotherapy possibly toxic to the mucosa
difficult follow up of the patient

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
Homeodent®Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.	Drug	Homeodent®
1.4% Sodium Bicarbonate solutionTwo-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing	Drug	1.4 % Sodium Bicarbonate solution

Primary outcome

Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported)
Time frame: At the end of irradiation period (6 weeks)

9 secondary outcomes

Rate of grade ≥2 mucositis
Time frame: At the end of irradiation period (6 weeks)
Rate of Mycosis and Herpes virus infection
Time frame: At the end of irradiation period (6 weeks)
Rate of use of symptomatic treatment in case of occurrence of mucositis
Time frame: At the end of irradiation period (6 weeks)
Rate and duration of radiation treatment interruption for toxicity
Time frame: At the end of irradiation period (6 weeks)
radiation dose, duration of grade ≥3 mucositis, maximum weight loss and maximum level of oral pain in case of grade ≥3 mucositis.
Time frame: during the occurence of grade≥3 mucositis
Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance
Time frame: during medication administration
Nutritional intake, estimated using caloric intake and the Detsky score, and rate of enteral and/or parenteral nutrition, in case of toxicity during irradiation
Time frame: during the period of toxicity
Rate of agreement between the radiation oncologist and the stomatologist for the detection of Grade ≥2 (RTOG classification) mucositis
Time frame: At the end of irradiation period (6 weeks)
Evaluation of the cost of severe mucositis treatment
Time frame: during and until the end of severe mucositis treatment

Results and safety

The study was stopped early (reason given: insufficient recruitment, the planed sample size appears not achievable). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
Background: PubMed 12742264Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.
Background: PubMed 14648865Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy: part 1, pathogenesis and prophylaxis of mucositis. Head Neck. 2003 Dec;25(12):1057-70. doi: 10.1002/hed.10318.
Background: PubMed 15782422Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
Background: PubMed 14724910Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy. Part 2: diagnosis and management of mucositis. Head Neck. 2004 Jan;26(1):77-84. doi: 10.1002/hed.10326.
Background: PubMed 11797271Lapeyre M, Charra-Brunaud C, Kaminsky MC, Geoffrois L, Dolivet G, Toussaint B, Maire F, Pourel N, Simon M, Marchal C, Bey P. [Management of mucositis following radiotherapy for head and neck cancers]. Cancer Radiother. 2001 Nov;5 Suppl 1:121s-130s. French.
Background: PubMed 15106165Worthington HV, Clarkson JE, Eden OB. Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2004;(2):CD001973. doi: 10.1002/14651858.CD001973.pub2.
Background: PubMed 16625538Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD000978. doi: 10.1002/14651858.CD000978.pub2.
Background: PubMed 14967419Trotti A, Garden A, Warde P, Symonds P, Langer C, Redman R, Pajak TF, Fleming TR, Henke M, Bourhis J, Rosenthal DI, Junor E, Cmelak A, Sheehan F, Pulliam J, Devitt-Risse P, Fuchs H, Chambers M, O'Sullivan B, Ang KK. A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):674-81. doi: 10.1016/S0360-3016(03)01627-4.
Background: PubMed 12351592El-Sayed S, Nabid A, Shelley W, Hay J, Balogh J, Gelinas M, MacKenzie R, Read N, Berthelet E, Lau H, Epstein J, Delvecchio P, Ganguly PK, Wong F, Burns P, Tu D, Pater J. Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system. J Clin Oncol. 2002 Oct 1;20(19):3956-63. doi: 10.1200/JCO.2002.05.046.
Background: PubMed 12643006Dodd MJ, Miaskowski C, Greenspan D, MacPhail L, Shih AS, Shiba G, Facione N, Paul SM. Radiation-induced mucositis: a randomized clinical trial of micronized sucralfate versus salt & soda mouthwashes. Cancer Invest. 2003;21(1):21-33. doi: 10.1081/cnv-120016400.
Background: PubMed 12671696Stokman MA, Spijkervet FK, Burlage FR, Dijkstra PU, Manson WL, de Vries EG, Roodenburg JL. Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial. Br J Cancer. 2003 Apr 7;88(7):1012-6. doi: 10.1038/sj.bjc.6600824.
Background: PubMed 12243825Saarilahti K, Kajanti M, Joensuu T, Kouri M, Joensuu H. Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):479-85. doi: 10.1016/s0360-3016(02)02935-8.

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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.

Pascal POMMIER principal investigator

Centre Léon Bérard, Lyon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Homeodent® and 1.4% Sodium Bicarbonate solution in people with Oropharynx Cancer and Hypopharynx Cancer, run by Centre Leon Berard at 1 site in France.

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 7 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: stopped early, as of the sponsor's last update on 1 Nov 2012. 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 France. 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 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 was stopped early (reason given: insufficient recruitment, the planed sample size appears not achievable). 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?

Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported) (time frame: At the end of irradiation period (6 weeks)). 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 NCT01066741, which also lists 17 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 1 Nov 2012.