Phase 3
N=176
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
Breast Cancer · Dermatologic Complications · Radiation Toxicity · Skin Reactions Secondary to Radiation Therapy
Bottom Line
View on ClinicalTrials.gov: NCT00438659 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. — 1.2; 1.3 Grade — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mometasone furoate (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- North Central Cancer Treatment Group
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. |
1.2; 1.3 | 0.18 |
| SECONDARY Incidence of Severe ( Grade >=3) Radiation Dermatitis |
80; 78; 4; 4 | — |
| SECONDARY Skin Toxicity as Measured by the Skin Toxicity Assessment Tool |
1.5; 2.1; 1.5; 2.2; 1.0; 1.4 | — |
| SECONDARY Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). |
1.4; 1.7 | — |
| SECONDARY Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis. |
— | — |
| SECONDARY Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) |
85; 82 | — |
| SECONDARY QOL Domains as Measured by LASA |
86; 84; 83; 79; 85; 80 | — |
| SECONDARY Adverse Events Assessed Clinically by NCI CTCAE v3.0 |
1; 0; 32; 32; 6; 5 | — |
| SECONDARY Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). |
5.1; 6.8; 2.7; 3.1; 1.3; 1.6 | — |
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.
Eligibility Criteria
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 contraception
- Able to complete questionnaires independently or with assistance
- No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the planned radiotherapy treatment area
- No concurrent or planned leukotriene inhibitors, including the following:
- Zafirleukast
- Monteleukast
- Zileuton
- No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:
- Cortaid®
- Cortizone 10®
- Tucks®
- Preparation H®
- No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment
Data sourced from ClinicalTrials.gov (NCT00438659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.