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MucositisPhase 2NCT01674374

Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy

A Phase 2 study testing quality-of-life assessment, questionnaire administration and Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules in people with Mucositis and Recurrent Squamous Cell Carcinoma of the Hypopharynx, run by Roswell Park Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on by chemotherapy and radiation therapy for… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
quality-of-life assessment, questionnaire administration and Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
May 2013to Jul 2015
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

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Patients with no distant metastatic disease
  • Have histologically proven diagnosis of squamous cell carcinoma (stage III - IV) of the paranasal sinuses, nasopharynx, larynx, hypopharynx, oral cavity and/or oropharynx; treated with definitive concurrent chemoradiotherapy; OR histologically proven diagnosis of squamous cell carcinoma of the paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx with finding of need for concurrent chemoradiotherapy (extracapsular extension, positive surgical margin, more than one lymph node positive, stage III - IV disease, perineural invasion, vascular tumor embolus); other rare histologies which are treated as per the guidelines of this protocol may be allowed with approval of the medical monitor
  • Concurrent monochemotherapy with cisplatin
  • Radiation therapy to 70 Gray (Gy) to gross tumor in 2 Gy per fraction over 7 weeks using intensity modulated radiation therapy (IMRT) techniques for patients with intact tumors, and 60 Gy - 66 Gy in 2 Gy per fraction using IMRT for post-operative patients
  • Induction chemotherapy (with up to 3 cycles of docetaxel and cisplatin based regimens) is allowed
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  • Ability to swallow and retain oral medication
  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit normal (ULN)
  • Calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault equation)
  • Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • Contraindication to full course chemoradiotherapy
  • ECOG performance status >= 3
  • Presence of distant metastatic disease
  • Surgery with significant defect or flap in the oral cavity
  • Poor dentition, ill-fitting dental appliances, obturators or any kind of resection prosthesis (can be enrolled if this can be corrected by a dentist prior to start of radiation therapy)
  • Presence of other medical conditions causing mucositis (e.g., rheumatologic, severe gastroesophageal reflux, etc. at the discretion of the physician)
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  • Previous radiotherapy on head and neck district involving mucosa of oral cavity and/or oropharynx
  • Use of chronic immunosuppressive drugs
  • Brachytherapy or interstitial implantation treatment
  • Other medical conditions that could make the patient not able to comply with the treatment
  • Requirement of chronic steroid therapy (except when given for laryngeal edema)
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment

About this study

Official title: A Phase 2 Placebo Controlled Randomized Study of the Effect of SAMITAL on Severity and Duration of Mucositis Induced by Chemoradiation for Head and Neck Cancer (HNC)

The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the tolerability of SAMITAL granules for suspension. II. To assess the efficacy of SAMITAL granules for suspension in reducing the incidence of severe mucositis (World Health Organization [WHO] mucositis scale score of 3 or 4) induced by concurrent chemoradiation for head and neck cancer (HNC).

SECONDARY OBJECTIVES:

  1. To assess the effect of SAMITAL granules for suspension on the severity and duration of mucositis (WHO mucositis scale and patient self-assessment with the Oral Mucositis Daily Questionnaire [OMDQ]).

II. To assess the effect of SAMITAL granules for suspension on validated patient reported quality of life measures (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30 and EORTC QLQ Head and Neck Cancer Specific Module).

III. To assess the rate of any grade 3 - grade 4 infections. IV. To assess the cumulative dose of opioids needed. V. To assess weight loss and need for tube feeding. VI. To assess treatment breaks and/or chemotherapy dose reduction.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Beginning as soon as symptoms arise during chemoradiotherapy, patients receive Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules orally (PO) four times daily (QID). Patients may continue to receive Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.

ARM II: Beginning as soon as symptoms arise during chemoradiotherapy, patients receive placebo PO QID. Patients may continue to receive placebo for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.

After completion of study treatment, patients are followed up for 3 months.

Being tested
placebo, quality-of-life assessment, questionnaire administration, Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules
Medical subject headings
Mucositis, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms

What participants receive

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

  • placeboOther

    Also called PLCB

    Given PO

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

  • questionnaire administrationOther

    Ancillary studies

  • Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granulesDrug

    Also called Samital granules, V. myrtillus/M. cordata/E. angustfolia granules

    Given PO

Study groups in NCT01674374
Study groupRoleWhat they receive
Arm I (SAMITAL)ExperimentalBeginning as soon as symptoms arise during chemoradiotherapy, patients receive Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules PO QID. Patients may continue to receive Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.
Receives: Procedure: quality-of-life assessment; Other: questionnaire administration; Drug: Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules
Arm II (placebo)Placebo comparatorBeginning as soon as symptoms arise during chemoradiotherapy, patients receive placebo PO QID. Patients may continue to receive placebo for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.
Receives: Other: placebo; Procedure: quality-of-life assessment; Other: questionnaire administration

What is being measured

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

  1. Proportion of patients with severe mucositis (WHO score 3 or 4)

    The 2 treatment groups will be compared using the Mantel-Haenszel test, stratified by disease site and type of therapy, using a two-sided test at the alpha= 0.10 level of significance. Since emphasis is placed on the accurate estimation of treatment effect for use in the planning of a future confirmatory trial, corresponding estimates of effect size will also be computed along with 90% confidence intervals.

    Measured: Up to 3 months after completion of study treatment

Secondary outcomes (3)

  1. Severity and duration of mucositis as assessed by dichotomized WHO Mucositis Global Severity Score (0-2 vs 3-4) and/or OMDQ scores

    The 2 treatment groups will be compared. The Mantel-Haenszel test, stratified by disease site and type of therapy, will be used for these comparisons.

    Measured: Up to 3 months after completion of study treatment

  2. Quality of life as assessed by EORTC QLQ-C30 questionnaire (with 1 being not at all and 4 being very much)

    The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.

    Measured: Up to 3 months after completion of study treatment

  3. Quality of Life as assessed by EORTC QLQ Head and Neck Cancer-Specific Module function and symptom sub-scores between groups (with 1 being not at all and 4 being very much)

    The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.

    Measured: Up to 3 months after completion of study treatment

Timeline

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

  1. First posted28 Aug 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionJul 2015 (estimated)

Resources

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
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674374
Sponsor's protocol ID
I 184910
Other IDs
NCI-2012-01030
Status last verified
May 2013
First submitted
2 Aug 2012
Last updated
15 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing quality-of-life assessment, questionnaire administration and Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules in people with Mucositis and Recurrent Squamous Cell Carcinoma of the Hypopharynx, run by Roswell Park Cancer Institute.

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 15 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 May 2013. 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 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 was withdrawn before enrolling participants, so there are no results.

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 patients with severe mucositis (WHO score 3 or 4) (time frame: Up to 3 months after completion of study treatment). 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 NCT01674374.

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 15 May 2013.

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