Effect of a Protein-rich Supplement and its natural components on the health and nutritional status of people with Head and Neck Cancer

Effect of High-protein Supplementation with Bioactive Peptides on nutritional and clinical outcomes in patients with Head and Neck Cancer: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-6vnxjrr

Enrollment

120

Registered

2026-07-20

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms Malignant Neoplasm of the Head, Face, and Neck

Interventions

This randomized controlled clinical trial aims to evaluate the effect of oral high-protein supplementation with bioactive peptides (Body Strong Protein) on the maintenance or attenuation of lean body

s standard normoproteic supplementation, both combined with individualized nutritional counseling. Participants will be randomly assigned using an electronic randomization system implemented in the RE

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults aged over 18 years; histopathologically confirmed diagnosis of Head and Neck Cancer (oral cavity, nasal cavity, nasopharynx, oropharynx, hypopharynx, or larynx); indication for concurrent chemoradiotherapy as the primary treatment modality, regardless of disease stage; initiation of treatment (first cycle of chemotherapy concurrent with radiotherapy); no prior oncologic treatment (chemotherapy, immunotherapy, or radiotherapy); Karnofsky Performance Status (KPS) = 50

Exclusion criteria

Exclusion criteria: Severe uncontrolled comorbidities (HIV infection, active tuberculosis, or severe non-oncologic liver disease); impaired oral intake (moderate to severe dysphagia); specialized nutritional follow-up outside the study

Design outcomes

Primary

Measure	Time frame
The primary outcome is expected to be the proportion of participants with a =5% loss of lean body mass compared with baseline at the end of oncologic treatment, as assessed by bioelectrical impedance analysis	—

Secondary

Measure	Time frame
The secondary outcomes are expected to include changes in phase angle, displacement of the confidence ellipse determined by Bioelectrical Impedance Vector Analysis (BIVA), nutritional status according to the Global Leadership Initiative on Malnutrition (GLIM) criteria, handgrip strength, functional performance, protein intake, adherence to supplementation, treatment-related toxicities, quality of life, and treatment interruption due to nutritional causes	—

Measure

Time frame

The secondary outcomes are expected to include changes in phase angle, displacement of the confidence ellipse determined by Bioelectrical Impedance Vector Analysis (BIVA), nutritional status according to the Global Leadership Initiative on Malnutrition (GLIM) criteria, handgrip strength, functional performance, protein intake, adherence to supplementation, treatment-related toxicities, quality of life, and treatment interruption due to nutritional causes

—

Countries

Contacts

Public ContactAline Alves Soares

Liga Norte Riograndense Contra o Câncer

aline.alves@liga.org.br+55 (84) 99993-3569

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026