Head and Neck TumorNCT06905561
Topical Diclofenac for Prevention of Radiation-induced Dermatitis
A study testing Diclofenac Sodium Gel in people with Head and Neck Tumor and Breast Cancer, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
Trial summary
Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Tumor, Breast Cancer
- What is being tested?
- Diclofenac Sodium Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female which are 18 years of age or older
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
- The RTOG radiation dermatitis rating should be equal to 0 and the skin nutrition should be good
- The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10^9/L c. ANC≥1.5×10^9/L, d. PLT ≥100×10^9/L; (2) Biochemical examination must meet the following standards: a. BIL<1.5 times the upper limit of normal value (ULN), b. ALT and AST<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range.
- Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.
Who cannot join
- Pregnant or lactating women
- A known history of intolerance or allergy to any component of the investigational product;
- severe cardiopulmonary disease (such as unstable angina attacks, grade II cardiac insufficiency, acute myocardial infarction, acute episodes of chronic obstructive pulmonary disease, pulmonary heart disease);
- The acute phase is accompanied by inflammatory skin diseases, such as atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.
- Systemic diseases known to delay the skin healing process, such as diabetes or severe kidney failure;
- Skin rupture caused by malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311
yuecan zeng, doctor, 19946610752, wellyy2005@hainmc.edu.cn
junnv xu, doctor, 18208946196, xujunnv@sina.com
About this study
Official title: Topical Diclofenac for Prevention of Radiation-induced Dermatitis: A Single-center, Randomized Controlled Trial
Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. The Diclofenac is a COX-2 inhibitor and Nonsteroidal anti-inflammatory drugs whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Diclofenac sodium gel as a prophylactic method against the development of RID.
Read the detailed description
Radiation induced dermatitis (RID) is one of the most commonly reported adverse events of Head and neck tumor, breast cancer radiation therapy (RT). Radiation therapy toxicity is exhibited within hours to weeks of exposure and persisting throughout the course of treatment. Radiation induced dermatitis is a result of generation of reactive oxygen species (ROSs), which in return induces epidermal and dermal inflammatory responses. Radiation causes structural tissue damage, which trigger production of pro-inflammatory mediators; as NF-κB, COX-2, and cytokines such as IL-6, TNF-a, and IFN- γ. Subsequently erythema, ulceration, and edema are developed，then followed by thinning of the epidermis, dry desquamation. If damage is more severe, moist desquamation occur. It can be deduced that inflammatory response plays a significant role in the radiotherapy induced dermatitis.
There are many agents that are used in the management of RID in the clinical settings, however, up till now there is none supported by the guidelines. Radiation induced dermatitis occurrence, not only could it impair the patient's quality of life but it could also affect the RT course of treatment, which could negatively influence the cancer treatment. Therefore more effort is needed to find a method of prevention of RID, resulting from Head and neck tumor,breast cancer RT.
Diclofenac sodium gel, a COX-2 inhibitor and nonsteroidal anti-inflammatory drug (non-NSAID), is widely used to treat inflammatory conditions, and studies show that topical diclofenac has no safety concerns. It has been used for more than 20 years in patients with osteoarthritis without any significant adverse effects. The combination of diclofenac sodium as a COX-2 inhibitor and ionising radiation not only enhances the effect of radiation on tumour cells, but also improves radiation therapy for patients. Studies have shown that diclofenac sodium gel, through COX-2, can be used to prevent the development of capecitabine-induced hand-foot syndrome (HFS). RID upregulates COX-2 due to inflammatory stimulation, and COX-2 indirectly produces reactive oxygen species (ROS). The investigators conclude that diclofenac gel can reduce ROS by locally inhibiting COX-2 enzyme, thus preventing radiation dermatitis and reducing skin damage. Therefore, the investigators plan to conduct a study on the use of diclofenac sodium gel in radiation dermatitis to investigate the incidence of RID grade 2 and above at different time points after radiotherapy in patients with head and neck tumours, and whether it can reduce the incidence and severity of RID-related symptoms.
- Conditions
- Head and Neck Tumor, Breast Cancer
- Being tested
- Diclofenac Sodium Gel, Placebo gel
- Keywords
- Topical Diclofenac, Radiation-induced dermatitis, Prevention, Head and Neck tumor, Brest Cancer
- Medical subject headings
- Head and Neck Neoplasms, Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Sodium GelDrug
Diclofenac Sodium Gel were applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.
Placebo gelOther
The placebo does not contain the active ingredients of Jalosome, only the co-formulants.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group（diclofenac sodium gel ） | Experimental | In addition to routine skin care, diclofenac sodium gel was applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.Conventional health care:Minimize skin irritation, friction and excessive sun exposure in the irradiated area (level III to IV evidence), avoid wearing high-neck and tight clothing, and recommend low-neck tops. Subjects wash irradiated skin with water or wet towel, and wipe skin with dry towel to keep irradiated skin clean and dry. Receives: Drug: Diclofenac Sodium Gel |
| control group（Placebo Comparator） | Placebo comparator | In addition to routine skin care, Placebo gel was applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.Conventional health care:Minimize skin irritation, friction and excessive sun exposure in the irradiated area (level III to IV evidence), avoid wearing high-neck and tight clothing, and recommend low-neck tops. Subjects wash irradiated skin with water or wet towel, and wipe skin with dry towel to keep irradiated skin clean and dry. Receives: Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of development of grade ≥ 2 RID
If the patient developed grade ≥ 2 RID or not, RTOG standards were used for evaluation
Measured: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Secondary outcomes (8)
Evaluation of Time to develop grade ≥2 RID
EvaluationTime to develop grade ≥ 2 RID incidence, will be assessed by RTOG criteria based on the clinical presentation of Time to develop grade ≥2 RID
Measured: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Evaluation of Pain Intensity
Pain related assessment will be done through a Visual Analog Scale, with 0 being No pain and 10 being unbearable pain
Measured: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Evaluation of Incidence of Treatment-Emergent Adverse Events
Patients will be educated and instructed to report any adverse events
Measured: From the first day of radiotherapy through treatment completion(up to 7 weeks or 5 weeks)
Evaluation of Quality of life
Skin-related quality of life assessed through the Dermatology Life Quality Index (DLQI)
Measured: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Incidence of radiotherapy interruption
If the patient has been interrupted by RID or not
Measured: From the first day of radiotherapy through treatment completion (up to 7 weeks or 5 weeks)
The Concentration of inflammatory factors (IL-2、IL-4 、IL-6、IL-10、interferon-γ、TNF-α)
The differences in expression of inflammatory factors, such as IL-2 (pg/ml）,IL-4 (pg/ml）,IL-6 (pg/ml）,IL-10 (pg/ml）,interferon-γ（pg/ml） and TNF-α（pg/ml）.
Measured: Baseline（Day 0） and through study completion（Day 36 or Day 46）
The Concentration of inflammatory factors (WBC)
The differences in expression of inflammatory factors, such as WBC(10^9/L).
Measured: Baseline（Day 0） and through study completion（Day 36 or Day 46）
The Concentration of inflammatory factors (CRP)
The differences in expression of inflammatory factors, such as CRP（mg/L）.
Measured: Baseline（Day 0） and through study completion（Day 36 or Day 46）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumorStudies 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905561
- Sponsor's protocol ID
- 2025-K01-01
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Diclofenac for Prevention of Radiation-induced Dermatitis: A Single-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06905561
- Acronym / sponsor ID
- 2025-K01-01
- Conditions
- Head and Neck Tumor, Breast Cancer
- Keywords
- Topical Diclofenac, Radiation-induced dermatitis, Prevention, Head and Neck tumor, Brest Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- 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.
Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. The Diclofenac is a COX-2 inhibitor and Nonsteroidal anti-inflammatory drugs whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Diclofenac sodium gel as a prophylactic method against the development of RID.
Detailed description
Radiation induced dermatitis (RID) is one of the most commonly reported adverse events of Head and neck tumor, breast cancer radiation therapy (RT). Radiation therapy toxicity is exhibited within hours to weeks of exposure and persisting throughout the course of treatment. Radiation induced dermatitis is a result of generation of reactive oxygen species (ROSs), which in return induces epidermal and dermal inflammatory responses. Radiation causes structural tissue damage, which trigger production of pro-inflammatory mediators; as NF-κB, COX-2, and cytokines such as IL-6, TNF-a, and IFN- γ. Subsequently erythema, ulceration, and edema are developed，then followed by thinning of the epidermis, dry desquamation. If damage is more severe, moist desquamation occur. It can be deduced that inflammatory response plays a significant role in the radiotherapy induced dermatitis.
There are many agents that are used in the management of RID in the clinical settings, however, up till now there is none supported by the guidelines. Radiation induced dermatitis occurrence, not only could it impair the patient's quality of life but it could also affect the RT course of treatment, which could negatively influence the cancer treatment. Therefore more effort is needed to find a method of prevention of RID, resulting from Head and neck tumor,breast cancer RT.
Diclofenac sodium gel, a COX-2 inhibitor and nonsteroidal anti-inflammatory drug (non-NSAID), is widely used to treat inflammatory conditions, and studies show that topical diclofenac has no safety concerns. It has been used for more than 20 years in patients with osteoarthritis without any significant adverse effects. The combination of diclofenac sodium as a COX-2 inhibitor and ionising radiation not only enhances the effect of radiation on tumour cells, but also improves radiation therapy for patients. Studies have shown that diclofenac sodium gel, through COX-2, can be used to prevent the development of capecitabine-induced hand-foot syndrome (HFS). RID upregulates COX-2 due to inflammatory stimulation, and COX-2 indirectly produces reactive oxygen species (ROS). The investigators conclude that diclofenac gel can reduce ROS by locally inhibiting COX-2 enzyme, thus preventing radiation dermatitis and reducing skin damage. Therefore, the investigators plan to conduct a study on the use of diclofenac sodium gel in radiation dermatitis to investigate the incidence of RID grade 2 and above at different time points after radiotherapy in patients with head and neck tumours, and whether it can reduce the incidence and severity of RID-related symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group（diclofenac sodium gel ） | Experimental | Drug: Diclofenac Sodium GelIn addition to routine skin care, diclofenac sodium gel was applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.Conventional health care:Minimize skin irritation, friction and excessive sun exposure in the irradiated area (level III to IV evidence), avoid wearing high-neck and tight clothing, and recommend low-neck tops. Subjects wash irradiated skin with water or wet towel, and wipe skin with dry towel to keep irradiated skin clean and dry. |
| control group（Placebo Comparator） | Placebo comparator | Other: Placebo gelIn addition to routine skin care, Placebo gel was applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.Conventional health care:Minimize skin irritation, friction and excessive sun exposure in the irradiated area (level III to IV evidence), avoid wearing high-neck and tight clothing, and recommend low-neck tops. Subjects wash irradiated skin with water or wet towel, and wipe skin with dry towel to keep irradiated skin clean and dry. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female which are 18 years of age or older
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
- The RTOG radiation dermatitis rating should be equal to 0 and the skin nutrition should be good
- The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10^9/L c. ANC≥1.5×10^9/L, d. PLT ≥100×10^9/L; (2) Biochemical examination must meet the following standards: a. BIL<1.5 times the upper limit of normal value (ULN), b. ALT and AST<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range.
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- A known history of intolerance or allergy to any component of the investigational product;
- severe cardiopulmonary disease (such as unstable angina attacks, grade II cardiac insufficiency, acute myocardial infarction, acute episodes of chronic obstructive pulmonary disease, pulmonary heart disease);
- The acute phase is accompanied by inflammatory skin diseases, such as atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.
- Systemic diseases known to delay the skin healing process, such as diabetes or severe kidney failure;
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 |
|---|---|---|
| Diclofenac Sodium GelDiclofenac Sodium Gel were applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID. | Drug | Treatment group（diclofenac sodium gel ） |
| Placebo gelThe placebo does not contain the active ingredients of Jalosome, only the co-formulants. | Other | control group（Placebo Comparator） |
Primary outcome
Incidence of development of grade ≥ 2 RID
Time frame: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
If the patient developed grade ≥ 2 RID or not, RTOG standards were used for evaluation
8 secondary outcomes
Evaluation of Time to develop grade ≥2 RID
Time frame: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Evaluation of Pain Intensity
Time frame: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Evaluation of Incidence of Treatment-Emergent Adverse Events
Time frame: From the first day of radiotherapy through treatment completion(up to 7 weeks or 5 weeks)
Evaluation of Quality of life
Time frame: From the first day of radiotherapy until 2 weeks after the end of radiotherapy
Incidence of radiotherapy interruption
Time frame: From the first day of radiotherapy through treatment completion (up to 7 weeks or 5 weeks)
The Concentration of inflammatory factors (IL-2、IL-4 、IL-6、IL-10、interferon-γ、TNF-α)
Time frame: Baseline（Day 0） and through study completion（Day 36 or Day 46）
The Concentration of inflammatory factors (WBC)
Time frame: Baseline（Day 0） and through study completion（Day 36 or Day 46）
The Concentration of inflammatory factors (CRP)
Time frame: Baseline（Day 0） and through study completion（Day 36 or Day 46）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac Sodium Gel in people with Head and Neck Tumor and Breast Cancer, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuecan zeng (19946610752, wellyy2005@hainmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of development of grade ≥ 2 RID (time frame: From the first day of radiotherapy until 2 weeks after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.