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Oral Curcumin for Radiation Dermatitis

Primary Purpose

Radiation-induced Dermatitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Curcumin

Placebo

About this trial

This is an interventional prevention trial for Radiation-induced Dermatitis focused on measuring Oral Curcumin, Radiation Dermatitis, Breast Cancer Patients

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

curcumin

Placebo

Arm Description

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

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01246973

First Posted

November 22, 2010

Last Updated

February 8, 2016

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01246973

Brief Title

Oral Curcumin for Radiation Dermatitis

Official Title

Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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..

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiation-induced Dermatitis

Keywords

Oral Curcumin, Radiation Dermatitis, Breast Cancer Patients

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

686 (Actual)

8. Arms, Groups, and Interventions

Arm Title

curcumin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Intervention Type

Drug

Intervention Name(s)

Curcumin

Other Intervention Name(s)

Curcumin C3 Complex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Primary Outcome Measure Information:

Title

Mean Radiation Dermatitis Severity Score

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Percentage of Subjects With Moist Desquamation

Description

Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Ryan, PhD, MPH

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Oral Curcumin for Radiation Dermatitis

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