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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


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
See also
  Status Clinical Trial Phase
Completed NCT01714973 - Study of ST266 Versus Saline in Treating Skin Irritation From Radiation Phase 1
Completed NCT02556632 - Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer Phase 2
Completed NCT02369835 - Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy Phase 3
Recruiting NCT05284487 - Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel. N/A
Completed NCT03374995 - Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer N/A
Not yet recruiting NCT05114226 - A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury Phase 1
Withdrawn NCT05073172 - StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients N/A