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

May 14, 2013 updated by: Roswell Park Cancer Institute

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I (SAMITAL)
Beginning 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.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Drug: Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules
Given PO
Other Names:
  • Samital granules
  • V. myrtillus/M. cordata/E. angustfolia granules
PLACEBO_COMPARATOR: Arm II (placebo)
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.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Other: placebo
Given PO
Other Names:
  • PLCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with severe mucositis (WHO score 3 or 4)
Time Frame: Up to 3 months after completion of study treatment
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.
Up to 3 months after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity and duration of mucositis as assessed by dichotomized WHO Mucositis Global Severity Score (0-2 vs 3-4) and/or OMDQ scores
Time Frame: Up to 3 months after completion of study treatment
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.
Up to 3 months after completion of study treatment
Quality of life as assessed by EORTC QLQ-C30 questionnaire (with 1 being not at all and 4 being very much)
Time Frame: Up to 3 months after completion of study treatment
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.
Up to 3 months after completion of study treatment
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)
Time Frame: Up to 3 months after completion of study treatment
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.
Up to 3 months after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2015

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 24, 2012

First Posted (ESTIMATE)

August 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 184910
  • NCI-2012-01030 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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