Head-and-neck Squamous Cell CarcinomaPhase 2ROSAMNCT01941992
Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
A Phase 2 study testing SAMITAL® in people with Head-and-neck Squamous Cell Carcinoma and Oral Mucositis, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to: evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy. assess tolerability of SAMITAL and the impact on patients reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head-and-neck Squamous Cell Carcinoma, Oral Mucositis
- What is being tested?
- SAMITAL®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Jan 2018
- Phase
- Phase 2
- 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
- Histologically proven squamous cell carcinomas of the head-and-neck
- Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
- Stage III or IV disease without evidence of distant metastases
- Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
- Age ≥ 18 years
- Karnofsky Performance Status ≥70
Show all 12Show fewer
- Life expectancy ≥6 months
- Able to swallow and retain oral medication
- Good state of dentition
- Patients must be available for treatment and follow-up
- Confirmation of adequate contraception use by the patient and/or partner
- Signed informed consent
Who cannot join
- Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
- Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
- Chronic administration of steroids or immunosuppressants
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.
The purpose of this study is to:
- evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
- assess tolerability of SAMITAL and the impact on patients reported outcomes.
- Being tested
- SAMITAL®, Placebo sachets
- Keywords
- head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Stomatitis, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMITAL®Drug
Placebo sachetsDrug
| Study group | Role | What they receive |
|---|---|---|
| SAMITAL® sachets, oral suspension | Experimental | SAMITAL® sachets for oral suspension, 20 mL, four times a day. Receives: Drug: SAMITAL® |
| Placebo sachets | Placebo comparator | Placebo sachets for oral suspension, 20 mL, four times a day. Receives: Drug: Placebo sachets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.
Measured: Within 19 weeks after starting Radiotherapy
Secondary outcomes (1)
Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)
Measured: Within 19 weeks after starting Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2016
- Study completionJan 2018
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 Head-and-neck Squamous Cell CarcinomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Indena S.p.A
- Responsible party
- Sponsor
- Investigators
- Lucio Loreggian, MD, Principal investigator, Radiotherapy Department, Istituto Oncologico Veneto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941992
- Sponsor's protocol ID
- IOV-HN-1-2012 ROSAM
- Other IDs
- 2012-002046-20
- Acronym
- ROSAM
- Status last verified
- Sep 2018
- First submitted
- 8 Aug 2013
- Last updated
- 13 Sep 2018
- Results posted
- No
- Individual data sharing
- No
Publications
Fasanaro E, Del Bianco P, Groff E, Riva A, Petrangolini G, Busato F, Stritoni P, Scarzello G, Loreggian L, De Salvo GL. Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM). Cancers (Basel). 2022 Dec 15;14(24):6192. doi: 10.3390/cancers14246192.
PubMed 36551677
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.
- ClinicalTrials.gov ID
- NCT01941992
- Acronym / sponsor ID
- ROSAM / IOV-HN-1-2012 ROSAM
- Keywords
- head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Indena S.p.A
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Sep 2013 (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.
The purpose of this study is to:
- evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
- assess tolerability of SAMITAL and the impact on patients reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAMITAL® sachets, oral suspension | Experimental | Drug: SAMITAL®SAMITAL® sachets for oral suspension, 20 mL, four times a day. |
| Placebo sachets | Placebo comparator | Drug: Placebo sachetsPlacebo sachets for oral suspension, 20 mL, four times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven squamous cell carcinomas of the head-and-neck
- Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
- Stage III or IV disease without evidence of distant metastases
- Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
- Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
- Chronic administration of steroids or immunosuppressants
- Pregnancy.
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 |
|---|---|---|
| SAMITAL® | Drug | SAMITAL® sachets, oral suspension |
| Placebo sachets | Drug | Placebo sachets |
Primary outcome
Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.
Time frame: Within 19 weeks after starting Radiotherapy
1 secondary outcome
Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)
Time frame: Within 19 weeks after starting Radiotherapy
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 Sep 2018.
- Derived from this study: PubMed 36551677Fasanaro E, Del Bianco P, Groff E, Riva A, Petrangolini G, Busato F, Stritoni P, Scarzello G, Loreggian L, De Salvo GL. Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM). Cancers (Basel). 2022 Dec 15;14(24):6192. doi: 10.3390/cancers14246192.
- Individual participant dataSharing planned: No
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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.
Lucio Loreggian, MD principal investigator
Radiotherapy Department, Istituto Oncologico Veneto
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 SAMITAL® in people with Head-and-neck Squamous Cell Carcinoma and Oral Mucositis, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
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 12 inclusion and 4 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 13 Sep 2018. 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 Italy. 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 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?
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?
Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period. (time frame: Within 19 weeks after starting Radiotherapy). 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 NCT01941992, 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 13 Sep 2018.