Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT

NCT04996147 | Terminated

• 1 other identifier: 102/2019
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer. Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy. The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments. Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms; Acute adverse events; Long-term adverse events; Quality of life; Cognitive function; Physical function

Outcome Measures

Primary Outcomes (2)

• Quality of life (acute)

  Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)

  Change of global quality of life score from baseline to the end of treatment

• Quality of life (long-term)

  Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)

  Change of global quality of life score from baseline to 4 months after the treatment is completed

Secondary Outcomes (25)

• Fatigue (acute)

  Change of fatigue score from baseline to the end of treatment

• Fatigue (long-term)

  Change of fatigue score from baseline to 4 months after the treatment is completed

• Social functioning (acute)

  Change of body mass index from baseline to the end of treatment

• Social functioning (long-term)

  Change of body mass index from baseline to 4 months after the treatment is completed

• Body composition (acute)

  Change of body mass index from baseline to the end of treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients had to have more than 18 years, diagnosed with stage III to IVB HNSCC and proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone. Exclusion criteria was: 1) synchronous tumors or other comorbidities with associated uncontrolled symptoms; 2) inability to provide informed consent; 3) expected inability to fulfil the propose schedule and follow-up.

You may qualify if:

• Patients older than 18 years.
• Diagnosis of locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx), stage III-IVB.
• Proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.

You may not qualify if:

• Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
• Inability to provide informed consent.
• Expected inability to fulfil the propose schedule and follow-up.

Sponsors & Collaborators

• Associacao de Investigacao de Cuidados de Suporte em Oncologia: lead
• Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.: collaborator
• University Institute of Maia: collaborator

Study Sites (1)

Centro Hospitalar Vila Nova de Gaia / Espinho

Vila Nova de Gaia, Portugal

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Inês Leão, MD

  Centro Hospitalar Vila Nova de Gaia / Espinho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: August 9, 2021
• Study Start: June 1, 2019
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)