Phase II study of Ginkgo biloba in irradiated brain tumor patients: Effect on cognitive function, quality of life, and mood

Albert Attia, Stephen R. Rapp, L. Doug Case, Ralph D'Agostino, Glenn Lesser, Michelle Naughton, Kevin McMullen, Robin Rosdhal, Edward G. Shaw

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Ginkgo biloba has been reported to improve cognitive function in older adults and patients with Alzheimer's disease and multi-infarct dementia. We conducted an open-label phase II study of this botanical product in symptomatic irradiated brain tumor survivors. Eligibility criteria included: life expectancy C30 weeks, partial or whole brain radiation C6 months before enrollment, no imaging evidence of tumor progression in previous 3 months, or stable or decreasing steroid dose, and no brain tumor treatment planned while on study. The Ginkgo biloba dose was 120 mg/day (40 mg t.i.d.) for 24 weeks followed by a 6-week washout period. Assessments performed at baseline, 12, 24 (end of treatment), and 30 weeks (end of washout) included KPS, Functional Assessment of Cancer Therapy-Brain (FACT-Br), Profile of Mood States, Mini-Mental Status Exam, Trail Making Test Parts A (TMT-A) and B (TMT-B), Digit Span Test, Modified Rey Osterrieth Complex Figure (ROCF), California Verbal Learning Test Part II, and the F-A-S Test. Results: Of the 34 patients enrolled on study, 23 (68 %) completed 12 weeks of treatment and 19 (56 %) completed 24 weeks of treatment. There were significant improvements at 24 weeks in: executive function (TMT-B) (p = 0.007), attention/concentration (TMT-A) (p = 0.002), and nonverbal memory (ROCF-immediate/delayed recall) (p = 0.001/0.002), mood (p = 0.002), FACT-Br subscale (p = 0.001), and the FACT physical subscale (p = 0.003). Conclusions: Some improvement in quality of life and cognitive function were noted with Ginkgo biloba. However, treatment with Ginkgo biloba was associated with a high dropout rate.

Original languageEnglish
Pages (from-to)357-363
Number of pages7
JournalJournal of Neuro-Oncology
Volume109
Issue number2
DOIs
StatePublished - Sep 2012

Fingerprint

Ginkgo biloba
Brain Neoplasms
Cognition
Quality of Life
Trail Making Test
Therapeutics
Multi-Infarct Dementia
Verbal Learning
Executive Function
Life Expectancy
Short-Term Memory
Survivors
Alzheimer Disease
Steroids
Radiation
Brain

Keywords

  • Brain tumors
  • Cognitive function
  • Ginkgo biloba
  • Quality of life
  • Radiation

ASJC Scopus subject areas

  • Clinical Neurology
  • Cancer Research
  • Oncology
  • Neurology

Cite this

Phase II study of Ginkgo biloba in irradiated brain tumor patients : Effect on cognitive function, quality of life, and mood. / Attia, Albert; Rapp, Stephen R.; Case, L. Doug; D'Agostino, Ralph; Lesser, Glenn; Naughton, Michelle; McMullen, Kevin; Rosdhal, Robin; Shaw, Edward G.

In: Journal of Neuro-Oncology, Vol. 109, No. 2, 09.2012, p. 357-363.

Research output: Contribution to journalArticle

Attia, A, Rapp, SR, Case, LD, D'Agostino, R, Lesser, G, Naughton, M, McMullen, K, Rosdhal, R & Shaw, EG 2012, 'Phase II study of Ginkgo biloba in irradiated brain tumor patients: Effect on cognitive function, quality of life, and mood', Journal of Neuro-Oncology, vol. 109, no. 2, pp. 357-363. https://doi.org/10.1007/s11060-012-0901-9
Attia, Albert ; Rapp, Stephen R. ; Case, L. Doug ; D'Agostino, Ralph ; Lesser, Glenn ; Naughton, Michelle ; McMullen, Kevin ; Rosdhal, Robin ; Shaw, Edward G. / Phase II study of Ginkgo biloba in irradiated brain tumor patients : Effect on cognitive function, quality of life, and mood. In: Journal of Neuro-Oncology. 2012 ; Vol. 109, No. 2. pp. 357-363.
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abstract = "Ginkgo biloba has been reported to improve cognitive function in older adults and patients with Alzheimer's disease and multi-infarct dementia. We conducted an open-label phase II study of this botanical product in symptomatic irradiated brain tumor survivors. Eligibility criteria included: life expectancy C30 weeks, partial or whole brain radiation C6 months before enrollment, no imaging evidence of tumor progression in previous 3 months, or stable or decreasing steroid dose, and no brain tumor treatment planned while on study. The Ginkgo biloba dose was 120 mg/day (40 mg t.i.d.) for 24 weeks followed by a 6-week washout period. Assessments performed at baseline, 12, 24 (end of treatment), and 30 weeks (end of washout) included KPS, Functional Assessment of Cancer Therapy-Brain (FACT-Br), Profile of Mood States, Mini-Mental Status Exam, Trail Making Test Parts A (TMT-A) and B (TMT-B), Digit Span Test, Modified Rey Osterrieth Complex Figure (ROCF), California Verbal Learning Test Part II, and the F-A-S Test. Results: Of the 34 patients enrolled on study, 23 (68 {\%}) completed 12 weeks of treatment and 19 (56 {\%}) completed 24 weeks of treatment. There were significant improvements at 24 weeks in: executive function (TMT-B) (p = 0.007), attention/concentration (TMT-A) (p = 0.002), and nonverbal memory (ROCF-immediate/delayed recall) (p = 0.001/0.002), mood (p = 0.002), FACT-Br subscale (p = 0.001), and the FACT physical subscale (p = 0.003). Conclusions: Some improvement in quality of life and cognitive function were noted with Ginkgo biloba. However, treatment with Ginkgo biloba was associated with a high dropout rate.",
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AU - D'Agostino, Ralph

AU - Lesser, Glenn

AU - Naughton, Michelle

AU - McMullen, Kevin

AU - Rosdhal, Robin

AU - Shaw, Edward G.

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N2 - Ginkgo biloba has been reported to improve cognitive function in older adults and patients with Alzheimer's disease and multi-infarct dementia. We conducted an open-label phase II study of this botanical product in symptomatic irradiated brain tumor survivors. Eligibility criteria included: life expectancy C30 weeks, partial or whole brain radiation C6 months before enrollment, no imaging evidence of tumor progression in previous 3 months, or stable or decreasing steroid dose, and no brain tumor treatment planned while on study. The Ginkgo biloba dose was 120 mg/day (40 mg t.i.d.) for 24 weeks followed by a 6-week washout period. Assessments performed at baseline, 12, 24 (end of treatment), and 30 weeks (end of washout) included KPS, Functional Assessment of Cancer Therapy-Brain (FACT-Br), Profile of Mood States, Mini-Mental Status Exam, Trail Making Test Parts A (TMT-A) and B (TMT-B), Digit Span Test, Modified Rey Osterrieth Complex Figure (ROCF), California Verbal Learning Test Part II, and the F-A-S Test. Results: Of the 34 patients enrolled on study, 23 (68 %) completed 12 weeks of treatment and 19 (56 %) completed 24 weeks of treatment. There were significant improvements at 24 weeks in: executive function (TMT-B) (p = 0.007), attention/concentration (TMT-A) (p = 0.002), and nonverbal memory (ROCF-immediate/delayed recall) (p = 0.001/0.002), mood (p = 0.002), FACT-Br subscale (p = 0.001), and the FACT physical subscale (p = 0.003). Conclusions: Some improvement in quality of life and cognitive function were noted with Ginkgo biloba. However, treatment with Ginkgo biloba was associated with a high dropout rate.

AB - Ginkgo biloba has been reported to improve cognitive function in older adults and patients with Alzheimer's disease and multi-infarct dementia. We conducted an open-label phase II study of this botanical product in symptomatic irradiated brain tumor survivors. Eligibility criteria included: life expectancy C30 weeks, partial or whole brain radiation C6 months before enrollment, no imaging evidence of tumor progression in previous 3 months, or stable or decreasing steroid dose, and no brain tumor treatment planned while on study. The Ginkgo biloba dose was 120 mg/day (40 mg t.i.d.) for 24 weeks followed by a 6-week washout period. Assessments performed at baseline, 12, 24 (end of treatment), and 30 weeks (end of washout) included KPS, Functional Assessment of Cancer Therapy-Brain (FACT-Br), Profile of Mood States, Mini-Mental Status Exam, Trail Making Test Parts A (TMT-A) and B (TMT-B), Digit Span Test, Modified Rey Osterrieth Complex Figure (ROCF), California Verbal Learning Test Part II, and the F-A-S Test. Results: Of the 34 patients enrolled on study, 23 (68 %) completed 12 weeks of treatment and 19 (56 %) completed 24 weeks of treatment. There were significant improvements at 24 weeks in: executive function (TMT-B) (p = 0.007), attention/concentration (TMT-A) (p = 0.002), and nonverbal memory (ROCF-immediate/delayed recall) (p = 0.001/0.002), mood (p = 0.002), FACT-Br subscale (p = 0.001), and the FACT physical subscale (p = 0.003). Conclusions: Some improvement in quality of life and cognitive function were noted with Ginkgo biloba. However, treatment with Ginkgo biloba was associated with a high dropout rate.

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