Trials / Withdrawn

WithdrawnNCT01674374

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

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)

Status: Withdrawn
Phase: Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Roswell Park Cancer Institute · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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 squamous cell carcinoma of the head and neck

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.

Conditions

Interventions

Type	Name	Description
OTHER	placebo	Given PO
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies
DRUG	Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules	Given PO

Timeline

Start date: 2013-05-01
Primary completion: 2015-07-01
First posted: 2012-08-28
Last updated: 2013-05-15

Source: ClinicalTrials.gov record NCT01674374. Inclusion in this directory is not an endorsement.