Oral Curcumin for Radiation Dermatitis

Radiation-induced Dermatitis Clinical Trial

Official title:

Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246973
• Other study ID #: URCC 10054
• Secondary ID: URCC 09005U10CA0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 22, 2010
• Last updated: February 8, 2016
• Start date: February 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether curcumin, an ingredient of some foods, can prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues..

Description:

Radiation is a toxic agent and a widely accepted form of treatment for various types of cancer. Approximately half of all women with breast cancer receive radiation therapy. Despite advances in medical technology, radiation therapy still causes severe skin effects. Radiation dermatitis occurs in approximately 90% of patients and ranges in severity from mild redness to more severe skin changes. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it; currently, there is no standard treatment for the prevention of radiation-induced dermatitis. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues.

Other known NCT identifiers

• NCT01238198

Recruitment information / eligibility

• Status: Completed
• Enrollment: 686
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 120 Years

Eligibility

Inclusion Criteria:

• a diagnosis of non-inflammatory breast adenocarcinoma (including in situ and bilateral)

• scheduled to begin radiotherapy without concurrent chemotherapy; concurrent hormone or Herceptin® (trastuzumab)treatment is okay

• can have been treated by lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment

• can have had breast reconstruction

• scheduled to receive 25-35 radiation treatment sessions (1 session per day) using standard irradiation fractionation (1.8-2.0 Gy per sessions) OR 16-20 radiation treatment sessions (1 session per day) using Canadian irradiation fractionation (2.2-3.0 Gy per session)(100, 101).

• able to swallow medication.

• three weeks must have elapsed after chemotherapy and surgery before the patient can begin the study

• able to understand English

Exclusion Criteria:

• inflammatory breast cancer

• previous radiation therapy to the breast or chest

• concurrent chemotherapy treatment

• concurrent treatment with anti-coagulants (e.g., coumadin®, warfarin®), or anti-EGFR (human epidermal growth factor receptor) drugs (e.g. Iressa® (gefitinib), Erbitux® (cetuximab, C225); aspirin is allowed

• known radiosensitivity syndromes (e.g., Ataxia-telangiectasia)

• collagen vascular disease, unhealed surgical sites, or breast infections

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Radiation-induced Dermatitis
• Radiodermatitis

Intervention

Drug:
• Curcumin
4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
• Placebo
4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Radiation Dermatitis Severity Score	The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.	6 weeks	No
Secondary	Percentage of Subjects With Moist Desquamation	Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.	6 weeks	No