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Spots Global Cancer Trial Database for Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy

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Trial Identification

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

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)

Study ID: NCT01674374

Conditions

Mucositis
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Oropharynx
Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Tongue Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Anurag Singh

Affiliation: Roswell Park Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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