Prospective observational study of cancer-cachexia and its effect on chemotherapy in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)

Prospective observational study of cancer-cachexia and its effect on chemotherapy in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A) - Prospective observational study of cancer-cachexia in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041813

Enrollment

200

Registered

2020-09-16

Start date

2020-11-30

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

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Pathologically diagnosed NSCLC. (2) Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy (3) Patients who have cachexia (meet one of the following (i) or (ii); (i) weight loss > 5% within the last 6 months, (i) BMI < 20 and weight loss > 2% within the last 6 months). (4) No prior systemic treatment with systemic anti-cancer therapy for advanced NSCLC. Subjects who received prior adjuvant and/or neo-adjuvant therapies are eligible. (5) Subjects scheduled to receive chemotherapy. (6) ECOG PS of 0 to 2. (7) Aged 20 years or more. (8) Provided Informed Consent.

Exclusion criteria

Exclusion criteria: (1) Current use of corticosteroids. (2) Subjects scheduled to receive treatment, but don't fit into cohorts 1, 2, or 3. (3) Subjects who are unable to accurately complete the QOL questionnaire. (4) Subjects who are judged by the principal or sub-investigator to be unsuitable for inclusion in this study.

Design outcomes

Primary

Measure	Time frame
Transition of FAACT (A/CS) during chemotherapy	—

Secondary

Measure	Time frame
Questionnaire for eating-related distress among patients with advanced cancer (QERD), Care Notebook, FACT-G, anchor questionnaire, ECOG PS, KPS, body weight, objective response rate, disease control rate, progression-free survival, overall survival, adverse events, minimally important difference in QERD, validation of QERD, proportion of cachexia	—

Countries

Japan

Contacts

Public ContactKeita Miura

Juntendo University Graduate School of Medicine Department of Respiratory Medicine

k-miura@juntendo.ac.jp03-3813-3111

Outcome results