NCT06661265

Predictors of Acute Toxicity and Flap Failure After Adjuvant Treatment for Locally Advanced Head and Neck Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Head and Neck cancer treatment may have significant functional consequences. Decisions about treatment are usually hard to make, as they must strike a balance between efficacy of the treatment and likelihood of survival. Reconstructive surgery with flaps plays a key role in the head and neck cancer resection in order to achieve local control, but often leaves a large, disfiguring composite defect that not only compromises the patient's functional and aesthetic outcome, but also significantly affects quality of life. Adjuvant treatment, including post operative Radiation Therapy (poRT) and chemotherapy, is crucial in improving locoregional control and survival in locally-advanced cases and the flaps are usually included in radiotherapy fields. Fourthysix patients undergoing to reconstructive surgery followed by radiation or chemioradiation between Decembre 2017 to December 2022 at San Raffaele Hospital will be enrolled in this study. The first aim of the study is to understand potential predictors of the occurrence of overall acute toxicity following adjuvant treatment in locally-advanced head and neck cancers submitted to upfront surgery with flap reconstruction. By analyzing patient data and treatment variables, the study aims at identifying factors that may influence the incidence and severity of acute treatment-related toxicities, such as mucositis, dysphagia, xerostomia and dermatitis. The second aim of the study is to evaluate whether the same variables may influence the viability and integrity of the flap at the end of the adjuvant treatment.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant tomotherapy +- chemotherapy after the reconstructive surgery with flaps	adjuvant treatment in locally-advanced head and neck cancers submitted to upfront surgery with flap reconstruction, evaluation of toxicity and flap status performed at San Raffaele Hospital between December 2017-December 2022.

Timeline

• Start date: 2024-11-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-10-28
• Last updated: 2024-11-01