RadiodermatitisNCT02922244
Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
A study testing Cucumber cream, Centella cream and Thunbergia cream in people with Radiodermatitis and Breast Neoplasms, run by Chulabhorn Cancer Center at 1 site in Thailand.
Trial summary
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Radiodermatitis, Breast Neoplasms, Adverse Effect of Radiation Therapy
- What is being tested?
- Cucumber cream, Centella cream and Thunbergia cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- May 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years old or older,
- Diagnosed with Breast cancer
- On course of external Radiation therapy
Who cannot join
- Pregnant
- Previously underwent external Radiation therapy
- Illiterate
Trial locations and contacts
1 site in 1 country.
About this study
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer
Read the detailed description
To compare the effect of each herb extracts to protect the skin from the adverse effects of radiation therapy in patients with breast cancer with herbal extract products.
- Being tested
- Control, Cucumber cream, Centella cream, Thunbergia cream
- Keywords
- herbal products, reduction of radiation-induced dermatitis, breast cancer, radiotherapy
- Medical subject headings
- Radiodermatitis, Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Apply moisture cream to the treatment skin everyday after radiation therapy
Cucumber creamOther
Apply cucumber cream to the treatment skin everyday after radiation therapy
Centella creamOther
Also called Centella asiatica
Apply centella cream to the treatment skin everyday after radiation therapy
Thunbergia creamOther
Also called Thunbergia laurifolia Lindl
Apply thunbergia cream to the treatment skin everyday after radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard skin care | No intervention | standard skin care |
| Control | Placebo comparator | Moisture Cream Receives: Other: Control |
| Cucumber cream | Active comparator | Apply Cucumber cream everyday after radiation therapy on the treatment aria skin. Receives: Other: Cucumber cream |
| Centella cream | Active comparator | Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin. Receives: Other: Centella cream |
| Thunbergia cream | Active comparator | Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin. Receives: Other: Thunbergia cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of dermatitis grading
RTOG (Radiation Therapy Oncology Group) Cooperative Group Common Toxicity Criteria Skin Grade 0:None or no change Grade 1:Scattered macular or papular eruption or erythema that is asymptomatic Grade 2:Scattered macular or papular eruption or erythema with pruritis or other associated symptoms Grade 3:Generalized symptomatic macular, papular, or vesicular eruption Grade 4:Exfoliative dermatitis or ulcerating dermatitis Grade 5:If that toxicity caused the death of the patient.
Measured: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.
Secondary outcomes (1)
Patient satisfaction with the cream
Scoring 1-4
- not satisfied
- slightly satisfied
- moderately satisfied
- very satisfied
Measured: At 9 week from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saengrawee Thanthong, Chulabhorn Cancer Center
- Investigators
- Saengrawee Thanthong, M.N.S., Principal investigator, 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922244
- Sponsor's protocol ID
- 005/2559
- Status last verified
- Jun 2018
- First submitted
- 21 Sep 2016
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Chen YJ, Dai YS, Chen BF, Chang A, Chen HC, Lin YC, Chang KH, Lai YL, Chung CH, Lai YJ. The effect of tetrandrine and extracts of Centella asiatica on acute radiation dermatitis in rats. Biol Pharm Bull. 1999 Jul;22(7):703-6. doi: 10.1248/bpb.22.703.
PubMed 10443466Gohil KJ, Patel JA, Gajjar AK. Pharmacological Review on Centella asiatica: A Potential Herbal Cure-all. Indian J Pharm Sci. 2010 Sep;72(5):546-56. doi: 10.4103/0250-474X.78519.
PubMed 21694984Haleagrahara N, Ponnusamy K. Neuroprotective effect of Centella asiatica extract (CAE) on experimentally induced parkinsonism in aged Sprague-Dawley rats. J Toxicol Sci. 2010 Feb;35(1):41-7. doi: 10.2131/jts.35.41.
PubMed 20118623Johnke RM, Sattler JA, Allison RR. Radioprotective agents for radiation therapy: future trends. Future Oncol. 2014 Dec;10(15):2345-57. doi: 10.2217/fon.14.175.
PubMed 25525844McQuestion M. Evidence-based skin care management in radiation therapy. Semin Oncol Nurs. 2006 Aug;22(3):163-73. doi: 10.1016/j.soncn.2006.04.004.
PubMed 16893745Momm F, Weissenberger C, Bartelt S, Henke M. Moist skin care can diminish acute radiation-induced skin toxicity. Strahlenther Onkol. 2003 Oct;179(10):708-12. doi: 10.1007/s00066-003-1142-9.
PubMed 14566480Nema NK, Maity N, Sarkar B, Mukherjee PK. Cucumis sativus fruit-potential antioxidant, anti-hyaluronidase, and anti-elastase agent. Arch Dermatol Res. 2011 May;303(4):247-52. doi: 10.1007/s00403-010-1103-y. Epub 2010 Dec 14.
PubMed 21153830Wei LS, Wee W. Chemical composition and antimicrobial activity of Cymbopogon nardus citronella essential oil against systemic bacteria of aquatic animals. Iran J Microbiol. 2013 Jun;5(2):147-52.
PubMed 23825733
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02922244
- Acronym / sponsor ID
- 005/2559
- Keywords
- herbal products, reduction of radiation-induced dermatitis, breast cancer, radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chulabhorn Cancer CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer
Detailed description
To compare the effect of each herb extracts to protect the skin from the adverse effects of radiation therapy in patients with breast cancer with herbal extract products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard skin care | No intervention | –standard skin care |
| Control | Placebo comparator | Other: ControlMoisture Cream |
| Cucumber cream | Active comparator | Other: Cucumber creamApply Cucumber cream everyday after radiation therapy on the treatment aria skin. |
| Centella cream | Active comparator | Other: Centella creamApply Centella asiatica cream everyday after radiation therapy on the treatment aria skin. |
| Thunbergia cream | Active comparator | Other: Thunbergia creamApply Thunbergia cream everyday after radiation therapy on the treatment aria skin. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 20 years old or older,
- Diagnosed with Breast cancer
- On course of external Radiation therapy
Key exclusion criteria (3 listed)
- Pregnant
- Previously underwent external Radiation therapy
- Illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlApply moisture cream to the treatment skin everyday after radiation therapy | Other | Control |
| Cucumber creamApply cucumber cream to the treatment skin everyday after radiation therapy | Other | Cucumber cream |
| Centella creamAlso: Centella asiaticaApply centella cream to the treatment skin everyday after radiation therapy | Other | Centella cream |
| Thunbergia creamAlso: Thunbergia laurifolia LindlApply thunbergia cream to the treatment skin everyday after radiation therapy | Other | Thunbergia cream |
Primary outcome
Change of dermatitis grading
Time frame: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.
RTOG (Radiation Therapy Oncology Group) Cooperative Group Common Toxicity Criteria Skin Grade 0:None or no change Grade 1:Scattered macular or papular eruption or erythema that is asymptomatic Grade 2:Scattered macular or papular eruption or erythema with pruritis or other associated symptoms Grade 3:Generalized symptomatic macular, papular, or vesicular eruption Grade 4:Exfoliative dermatitis or ulcerating dermatitis Grade 5:If that toxicity caused the death of the patient.
1 secondary outcome
Patient satisfaction with the cream
Time frame: At 9 week from date of randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Results publication: PubMed 10443466Chen YJ, Dai YS, Chen BF, Chang A, Chen HC, Lin YC, Chang KH, Lai YL, Chung CH, Lai YJ. The effect of tetrandrine and extracts of Centella asiatica on acute radiation dermatitis in rats. Biol Pharm Bull. 1999 Jul;22(7):703-6. doi: 10.1248/bpb.22.703.
- Results publication: PubMed 21694984Gohil KJ, Patel JA, Gajjar AK. Pharmacological Review on Centella asiatica: A Potential Herbal Cure-all. Indian J Pharm Sci. 2010 Sep;72(5):546-56. doi: 10.4103/0250-474X.78519.
- Results publication: PubMed 20118623Haleagrahara N, Ponnusamy K. Neuroprotective effect of Centella asiatica extract (CAE) on experimentally induced parkinsonism in aged Sprague-Dawley rats. J Toxicol Sci. 2010 Feb;35(1):41-7. doi: 10.2131/jts.35.41.
- Results publication: PubMed 25525844Johnke RM, Sattler JA, Allison RR. Radioprotective agents for radiation therapy: future trends. Future Oncol. 2014 Dec;10(15):2345-57. doi: 10.2217/fon.14.175.
- Results publication: PubMed 16893745McQuestion M. Evidence-based skin care management in radiation therapy. Semin Oncol Nurs. 2006 Aug;22(3):163-73. doi: 10.1016/j.soncn.2006.04.004.
- Results publication: PubMed 14566480Momm F, Weissenberger C, Bartelt S, Henke M. Moist skin care can diminish acute radiation-induced skin toxicity. Strahlenther Onkol. 2003 Oct;179(10):708-12. doi: 10.1007/s00066-003-1142-9.
- Results publication: PubMed 21153830Nema NK, Maity N, Sarkar B, Mukherjee PK. Cucumis sativus fruit-potential antioxidant, anti-hyaluronidase, and anti-elastase agent. Arch Dermatol Res. 2011 May;303(4):247-52. doi: 10.1007/s00403-010-1103-y. Epub 2010 Dec 14.
- Results publication: PubMed 23825733Wei LS, Wee W. Chemical composition and antimicrobial activity of Cymbopogon nardus citronella essential oil against systemic bacteria of aquatic animals. Iran J Microbiol. 2013 Jun;5(2):147-52.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saengrawee Thanthong, M.N.S. principal investigator
54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cucumber cream, Centella cream and Thunbergia cream in people with Radiodermatitis and Breast Neoplasms, run by Chulabhorn Cancer Center at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of dermatitis grading (time frame: Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922244, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.