Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy
NCT01674374 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2013-05-15
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
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
Interventions
- 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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Anurag Singh · Roswell Park Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2015-07-31
More Related Trials
-
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
NCT00004234 ·Status: COMPLETED ·Phase: PHASE3
-
Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy
NCT04843644 ·Status: UNKNOWN ·Phase: NA
-
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
NCT00790322 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
NCT03268993 ·Status: COMPLETED ·Phase: NA
-
Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid
NCT07311772 ·Status: RECRUITING ·Phase: PHASE3
-
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
NCT01400620 ·Status: COMPLETED ·Phase: PHASE2
-
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
NCT02123511 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
NCT01469429 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
NCT00615420 ·Status: COMPLETED ·Phase: PHASE3
-
Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
NCT00008398 ·Status: COMPLETED ·Phase: PHASE3
-
Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
NCT01941992 ·Status: COMPLETED ·Phase: PHASE2
-
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
NCT01155609 ·Status: COMPLETED ·Phase: NA
-
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
NCT05966194 ·Status: RECRUITING ·Phase: PHASE2
-
Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
NCT00022373 ·Status: UNKNOWN ·Phase: PHASE3
-
Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
NCT05176834 ·Status: UNKNOWN ·Phase: NA
-
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
NCT04671862 ·Status: RECRUITING ·Phase: NA
-
Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
NCT02075749 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
NCT00004256 ·Status: COMPLETED ·Phase: PHASE2
-
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
NCT01837446 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
NCT01403064 ·Status: TERMINATED ·Phase: PHASE2
-
Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
NCT05040425 ·Status: UNKNOWN ·Phase: PHASE2
-
Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.
NCT05635929 ·Status: RECRUITING ·Phase: NA
-
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
NCT06532279 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of RK0202 in Oral Mucositis
NCT00230191 ·Status: COMPLETED ·Phase: PHASE2
-
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
NCT00101582 ·Status: COMPLETED ·Phase: PHASE3