Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .

NCT06484166 | Completed

• 1 other identifier: HX2024-134
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Radiotherapy always results in many complications such as radiation dermatitis, dry mouth, cranial nerve damage, and swallowing function. Among them, radiation dermatitis is confirmed to occur in the majority of tumor patients receiving radiotherapy, which not only affects the appearance but also causes the interruption of radiotherapy in severe cases. At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards. This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• The incidence of grade 2 or higher radiation dermatitis.

  Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

Secondary Outcomes (7)

• The time to onset of grade 2 or higher radiation dermatitis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• The duration of grade 2 or higher radiation dermatitis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• The maximum skin toxicity.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• The Skindex-16 instrument.

  From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

• EORTC QLQ-C30.

  From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

Study Arms (2)

Trolamine (Biafine)

ACTIVE COMPARATOR

Trolamine (Biafine; Genmedix Ltd, France) is cream packed in an opaque white bottle of 50g each, which is the same as the experimental group in appearance.

Drug: Trolamine (Biafine)

Fullerene cream

EXPERIMENTAL

Fullerene cream is cream packed in an opaque white bottle of 50g each, which is the same as the control group in appearance.

Other: Fullerene cream

Interventions

Fullerene cream OTHER

Patients are instructed to apply a thin layer of the Fullerene cream third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area.

Fullerene cream

Trolamine (Biafine) DRUG

Patients are instructed to apply a thin layer of the Trolamine (Biafine) third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area.

Trolamine (Biafine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• Patients considered candidates for high-dose RT either as primary treatment or as postoperative treatment after surgical resection and patients planned to receive concomitant boost fractionation or concurrent systemic chemotherapy.

You may not qualify if:

• Eastern Cooperative Oncology Group performance status of \>2;
• Pre-existing skin rash, ulceration or open wound in the treatment area;
• Known allergy to trolamine or fullerene;
• Inflammatory or connective tissue disorder of the skin;
• History of head and neck radiotherapy.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 646000, China

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

triethanolamine; Biafine

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)