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Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy
This study is currently recruiting participants.
Study NCT00768794   Information provided by Summa Health System
First Received: October 7, 2008   Last Updated: September 17, 2009   History of Changes

October 7, 2008
September 17, 2009
July 2006
July 2010   (final data collection date for primary outcome measure)
To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis. [ Time Frame: during duration of treatment of 4 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768794 on ClinicalTrials.gov Archive Site
To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy. [ Time Frame: during duration of treatment of 4 weeks. ] [ Designated as safety issue: No ]
Same as current
 
Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy
A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy

The purpose of this study is to determine the effectiveness of using acidophilus to treat oral candidiasis (thrush) caused by radiation therapy to the head and neck region.

This study will conducted in two parts. In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of your mouth that are painful, you will begin taking acidophilus capsules twice each day until the last day of radiation therapy.

The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region. In the second part of the study three participants will take acidophilus capsules twice each day beginning on the first day of radiation therapy and continuing until the last day of radiation therapy.

To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis.

To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily beginning on the first day of radiation treatments to the head and neck region prevents the development of oral thrush.

To assess subjective and objective response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements.

To assess the efficacy of Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements in preventing oral candidiasis in patients receiving radiation therapy to the head and neck region.

 
Interventional
Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Oral Candidiasis
  • Dietary Supplement: Acidophilus
  • Dietary Supplement: Acidolphilus
Active Comparator: In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of their mouth that are painful, subjects will begin taking acidophilus capsules twice each day until the last day of radiation therapy.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
5
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck region receiving > 50 Gy to head and neck tumor with or without concomitant chemotherapy and/or cetuximab.
  • Age ≥ 18
  • Karnofsky Performance Score of > 70
  • History and physical examination within 8 weeks prior to registration
  • Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
  • Patients with carcinoma in-situ of the breast, oral cavity, or cervix are eligible.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Acute bacterial or fungal infection requiring intravenous or oral antibiotics at study entry
  • Sjoren's syndrome
  • Hypoadrenalism
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  • Prior allergic reaction to Lactobacillus acidophilus.
Both
18 Years to 80 Years
No
Contact: Heather Tharpe, RN, BSN, OCN 330-375-4578 tharpeh@summa-health.org
Contact: Joyce Neading, RHIT, CTR 330-375-4221 neadingja@summa-health.org
United States
 
NCT00768794
Heather Tharpe, RN, BSN, OCN, Summa Health System
Acidophilus
Summa Health System
 
Principal Investigator: Heather Tharpe, Rn, BSN, OCN Summa Health System
Principal Investigator: Heather Tharpe, RN, BSN, OCN Summa Health System
Summa Health System
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP