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Completed

NCT Number: NCT00768794

Acidophilus for the Treatment and Prevention of Oral Candidiasis in 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.

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Key information

Conditions

Oral Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Oral Infections Mouth Diseases Mycoses Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Summa Health System

Akron, Ohio, 44304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acidophilus

Dietary Supplement

Use of Acidophilus 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.

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.

Acidolphilus

Dietary Supplement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Summa Health System

Other

Registry information

Official study title

A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2008
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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