Clinical trial · Interventional
Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa
An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy. Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Non-Myeloid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| darbepoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- darbepoetin alfa
- interventionNames
- Drug: darbepoetin alfa
Primary outcomes (2)
- measure
- Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score
- timeFrame
- baseline
- measure
- Relationship between hemoglobin (hgb) response and change in functional capacity
- timeFrame
- week 1, week 9, week 17
Secondary outcomes (12)
- measure
- Estimates of the sensitivity and specificity of the FCST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-myeloid malignancies * Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy * Plan to receive cyclic chemotherapy for an additional 8 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Adequate renal and liver function * Ability to participate in the MHST based on clinical judgement of investigator * At least 18 years of age Exclusion Criteria: * Iron deficiency * Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment * Unstable cardiac disease * Current active condition creating clinical danger for the subject to participate in the MHST * known positive test for HIV infection * Previous hematologic disorder associated with anemia * Currently receiving beta-blockers * Use of drugs or devices not approved by the FDA for any indication * Pregnant or breast feeding * Known hypersensitivity to any recombinant mammalian-derived product
References
Publications (3)
- RESULTVadhan-Raj S, Mirtsching B, Charu V, Terry D, Rossi G, Tomita D, McGuire WP. Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J Support Oncol. 2003 Jul-Aug;1(2):131-8. PMID 15352656
- RESULTKallich J, McDermott A, Xu X, Fayers P, Cella D. The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res. 2006 Feb;15(1):57-68. doi: 10.1007/s11136-005-8324-0. PMID 16411031
- RESULTCella D, Viswanathan HN, Hays RD, Mendoza TR, Stein KD, Pasta DJ, Foreman AJ, Vadhan-Raj S, Kallich JD. Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy. Cancer. 2008 Sep 15;113(6):1480-8. doi: 10.1002/cncr.23698. PMID 18642348