Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
الكلمات الدالة
نبذة مختصرة
وصف
Specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and psychophysiological factors, can predict the severity of radiation-induced dermatitis. Potential future research studies may be conducted to identify the biological mechanisms involved in radiation-induced dermatitis and the radioprotective function of curcumin.
تواريخ
آخر التحقق: | 05/31/2012 |
تم الإرسال لأول مرة: | 01/03/2010 |
تم إرسال التسجيل المقدر: | 01/04/2010 |
أول نشر: | 01/05/2010 |
تم إرسال آخر تحديث: | 06/18/2012 |
آخر تحديث تم نشره: | 06/24/2012 |
تاريخ أول النتائج المقدمة: | 01/25/2012 |
تاريخ أول نتائج مراقبة الجودة المقدمة: | 05/16/2012 |
تاريخ أول النتائج المنشورة: | 06/19/2012 |
تاريخ بدء الدراسة الفعلي: | 12/31/2007 |
تاريخ الإنجاز الأساسي المقدر: | 08/31/2010 |
التاريخ المتوقع لانتهاء الدراسة: | 03/31/2011 |
حالة أو مرض
التدخل / العلاج
Drug: Curcumin C3 Complex
Drug: Placebo
مرحلة
مجموعات الذراع
ذراع | التدخل / العلاج |
---|---|
Active Comparator: Curcumin C3 Complex Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks). | Drug: Curcumin C3 Complex Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks) |
Placebo Comparator: Placebo Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks). | Drug: Placebo Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks) |
معايير الأهلية
الأعمار المؤهلة للدراسة | 21 Years إلى 21 Years |
الأجناس المؤهلة للدراسة | Female |
يقبل المتطوعين الأصحاء | نعم |
المعايير | Inclusion Criteria: - Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy. - Participants must be at least 21 years of age. - Participants must not be pregnant. - Participants can be from any racial or ethnic origin. - Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment. - Participants with in situ breast cancer are eligible. - Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible. - Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation. - A time period of three weeks must elapse after chemotherapy and surgery before beginning the study. - The total dose prescribed to the whole breast should be 50 Gy or greater. - Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English). - Participants must be able to swallow medication. - Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically. - Participant must give informed consent. Exclusion Criteria: - Patients with bilateral breast cancer are not eligible. - Patients who have had previous radiation therapy to the breast or chest are not eligible. - Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible. - Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible. - Patients cannot have had breast reconstructions, implants, and/or expanders. - Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible. - Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible. - Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN). |
النتيجة
مقاييس النتائج الأولية
1. Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients [4-7 weeks (prescribed course of radiation)]
مقاييس النتائج الثانوية
1. Moist Desquamation at Radiation Treatment Site [4-7 weeks (prescribed course of radiation)]
2. Redness at Radiation Treatment Site [4-7 weeks (prescribed course of radiation)]
3. Pain at Radiation Treatment Site [4-7 weeks (prescribed course of radiation)]