NCT05126095

Brief Summary

Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss. Cone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 7, 2021

Last Update Submit

November 21, 2021

Conditions

Head and Neck CancerRadiotherapy; Adverse Effect

Keywords

Cone-beam Computerized tomographySkeletal Muscle MassBody weightMalnutrition

Outcome Measures

Primary Outcomes (1)

  • The treatment-related severe adverse events

    The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.

    7 weeks

Secondary Outcomes (5)

  • The weight loss percentage

    7 weeks

  • Scored Patient-Generated Subjective Global Assessment (PG-SGA)

    7 weeks

  • the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    7 weeks

  • the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)

    7 weeks

  • Duration ofParenteral nutrition

    7 weeks

Study Arms (1)

Trial cohort

CBCT: before radiotherapy and once a week during radiotherapy Body weight: before radiotherapy and once a week during radiotherapy The Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy.

Radiation: Radical radiotherapy

Interventions

Radical radiotherapyRADIATION

Intensity-modulated radiation therapy (IMRT)

Trial cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with locally advanced HNC scheduled to receive radical radiotherapy

You may qualify if:

  • Histologically confirmed HNC including Oral Cavity, Oropharyngeal, Nasopharynx, Hypopharyngeal, and Laryngeal Cancers
  • Clinical stage II-IVa according to the American Joint Committee of Cancer (the seventh edition)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

You may not qualify if:

  • Previous head and neck radiotherapy
  • Previous cervical lymph node dissection
  • Active infections
  • Palliative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YI PAN

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsRadiation InjuriesBody WeightMalnutrition

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • YI PAN, Prof.

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Pan, Prof.

CONTACT

+862083827812panyiff01@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 7, 2021

First Posted

November 18, 2021

Study Start

November 3, 2021

Primary Completion

June 14, 2022

Study Completion

March 30, 2023

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

CN(1)