Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
ConditionRadiation-Induced Skin Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy
Age ≥18 years and ≤75 years, any sex
Signed written informed consent
Radiation field skin area can be localized and skin inflammation can be assessed
Disqualifiers
Cognitive impairment preventing understanding of the study
Use of antibiotics or antifungals within 1 month
Previous treatment with other bacterial preparations
Participation in other bacterial therapy trials
Trial design
Design model
Single group
Treatments tested in this trial
AKK Topical Preparation
Biological/VaccineInactivated whole-cell Akkermansia muciniphila topical preparation. Dose: 140 µL per 25 cm² of radiation field (7 × 10⁷ CFU). Applied three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first radiotherapy fraction (after baseline skin sampling) and continues until 14 days after the last radiotherapy fraction.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experimental: AKK Topical PreparationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Grade ≥2 Acute Radiation Dermatitis
Proportion of participants developing grade 2 or higher acute radiation dermatitis (ARD) as assessed by RTOG and CTCAE v6.0 criteria during radiotherapy and follow-up.
Time frame
From first radiotherapy fraction up to 90 days after the last fractionSecondary outcomes
1
Changes in Skin Micro-Features on Digital Dermoscopy
Evolution of skin micro-features (e.g., erythema, scaling, vascular changes) observed by digital dermoscopy during treatment and follow-up.
Time frame
Baseline, weekly during radiotherapy, and at days 14, 30, 60, 90 after last radiotherapy fraction.2
Skin Microbiota Composition
Changes in the relative abundance of skin bacterial species measured from desquamated scale samples.
Time frame
Same as above.3
Frequency of Grade ≥3 Acute Radiation Dermatitis
Proportion of participants developing grade 3 or higher ARD assessed by RTOG/CTCAE v6.0.
Time frame
From first radiotherapy fraction to 90 days after last fraction.4
Duration of Grade 2/3/4 Acute Radiation Dermatitis
Number of days from first onset to resolution of grade 2, 3, or 4 ARD.
Time frame
During radiotherapy and up to 90 days after last fraction.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Hospital
Lead sponsor
West China-Jintang Hospital, Sichuan University
Collaborator
Source ClinicalTrials.gov