Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to… (NCT00438659) | Clinical Trial Compass
CompletedPhase 3
Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ
United States176 participantsStarted 2007-08
Plain-language summary
RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.
PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ
* Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:
* Whole breast (as part of breast-conservation therapy)
* Chest wall (as part of post-mastectomy irradiation)
* Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed
* Must meet the following criteria for planned radiotherapy:
* Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
* No planned split-course radiotherapy
* No partial breast treatment, defined as treatment of \< 75% of the breast parenchyma
* Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed
* Must be entered on study within 7 days prior to beginning radiotherapy
* Must start study drug prior to receiving the third radiotherapy fraction
* No preexisting skin breakdown within the planned radiotherapy field at the time of study entry
* No bilateral breast cancer treatment
* No inflammatory carcinoma of the breast
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contr…
What they're measuring
1
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.