A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer

A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer - A phase II study of collagen peptide-containing beverage during chemoradiotherapy for patients with head and neck cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045594

Enrollment

Registered

2021-09-29

Start date

2021-02-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

head and neck cancer

Interventions

Intake of collagen peptide (V CRESC)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) Age over 20 years (ii) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 (iii) Patients with head and neck cancer who will undergo definitive chemoradiotherapy or postoperative adjuvant chemoradiotherapy (iv) Be to receive over 50 Gy of irradiation for pharyngeal space or oral space (v) Be to receive cisplatin-based chemoradiotherapy (vi) Adequate hematological, liver and renal functions. (vii) Sufficient eating ability, normalcy of diet in performance status scale for head and neck cancer patients (PSSHN)>=50 (viii) Able to obtain more than 80% of required calorie calculated by Harris-Benedict Equation via oral intake at the initiation of chemoradiotherapy (ix) Absence of oral mucositis and dry mouth evaluated by CTCAE version 5.0 (x) Written informed consent was obtained from each patient

Exclusion criteria

Exclusion criteria: i. Patients who are taking supplement or drugs containing collagen peptide, and who will continue to take them throughout the chemotherapy ii. Patients who will receive palliative chemoradiotherapy iii. Women who are pregnant, contemplating pregnancy or amid breast-feeding iv. Mental disorders which is considered inappropriate for inclusion in the study v. Protein intake restriction vi. Hypersensitivity to the element of V CRESC vii. Unable to take V CRESC per oral viii. Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Proportion of patients able to obtain adequate nutrition via oral intake when the total radiation dose reached 42-50 Gy	—

Secondary

Measure	Time frame
Frequency of use of percutaneous endoscopic gastrostomy (PEG) for nutrition support Compliance with collagen peptide-containing beverage (V CRESC) use Serum albumin, total protein, and C-reactive protein at the initiation and the end of chemoradiotherapy Body weight loss from the initiation to the end of chemoradiotherapy Maximum dose of opioid used Adverse events associated with chemoradiotherapy, including oral mucositis, loss of appetite, nausea, vomiting, diarrhea, aspiration, and infection PRO-CTCAE Compliance with chemoradiotherapy Weekly total calories (kcal/day) and protein (kcal/day) during chemoradiotherapy surveyed by dieticians	—

Measure

Time frame

Frequency of use of percutaneous endoscopic gastrostomy (PEG) for nutrition support Compliance with collagen peptide-containing beverage (V CRESC) use Serum albumin, total protein, and C-reactive protein at the initiation and the end of chemoradiotherapy Body weight loss from the initiation to the end of chemoradiotherapy Maximum dose of opioid used Adverse events associated with chemoradiotherapy, including oral mucositis, loss of appetite, nausea, vomiting, diarrhea, aspiration, and infection PRO-CTCAE Compliance with chemoradiotherapy Weekly total calories (kcal/day) and protein (kcal/day) during chemoradiotherapy surveyed by dieticians

—

Countries

Japan

Contacts

Public ContactTomoya Yokota

Shizuoka Cancer Center Division of Gastrointestinal Oncology

t.yokota@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026