TRIAD Burden of Illness Mucositis Study

Status unconfirmed

Conditions studied: Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)

In brief

Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy treatment for various cancer types.

Key facts

Study ID

NCT00336609

Run by

TRIAD Burden of Illness

People needed

1600

Starts

2005-11-01

Expected to finish

2007-05-01

Last updated by the study team

2007-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Ability to understand the protocol and willing to provide written informed consent
• Membership in one of the following sub-cohorts:
• Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/- chemotherapy.
• Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/- chemotherapy.
• Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFOX +/- Avastin or Erbitux.1 cycle defined as 2 doses of FOLFOX.
• Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFIRI +/- Avastin or Erbitux. 1 cycle defined as 2 doses of FOLFIRI.
• Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC.
• Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine.
• Adenocarcinoma of the breast planned to receive standard or dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) (4 cycles AC followed by 2 cycles T).
• Stage 3A or 3B non-small cell lung cancers planned to receive daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- Carbo/Taxol.
• B-cell Non-Hodgkin's lymphoma (NHL) planned to receive at least 2 cycles of CHOP-14, CHOEP-14, CHOP-DI-14, EPOCH-14 or CHOP-21 +/- rituxan

Where it is running

• Univeristy Of Wisconsin — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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