Ashwagandha for Cognitive Dysfunction

Summary

This is a 1:1 randomized double blinded placebo controlled trial. • To determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for cancer.

Timeline

Start

2023-01-01

Primary completion

2024-12-31

Completion

2025-07-01

Publications

• Background Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.
• Background Ahles TA, Saykin AJ, Furstenberg CT, Cole B, Mott LA, Skalla K, Whedon MB, Bivens S, Mitchell T, Greenberg ER, Silberfarb PM. Neuropsychologic impact of standard-dose systemic chemotherapy in long-term survivors of breast cancer and lymphoma. J Clin Oncol. 2002 Jan 15;20(2):485-93. doi: 10.1200/JCO.2002.20.2.485.
• Background Inagaki M, Yoshikawa E, Matsuoka Y, Sugawara Y, Nakano T, Akechi T, Wada N, Imoto S, Murakami K, Uchitomi Y. Smaller regional volumes of brain gray and white matter demonstrated in breast cancer survivors exposed to adjuvant chemotherapy. Cancer. 2007 Jan 1;109(1):146-56. doi: 10.1002/cncr.22368.
• Background Wefel JS, Saleeba AK, Buzdar AU, Meyers CA. Acute and late onset cognitive dysfunction associated with chemotherapy in women with breast cancer. Cancer. 2010 Jul 15;116(14):3348-56. doi: 10.1002/cncr.25098.
• Background Hardy SJ, Krull KR, Wefel JS, Janelsins M. Cognitive Changes in Cancer Survivors. Am Soc Clin Oncol Educ Book. 2018 May 23;38:795-806. doi: 10.1200/EDBK_201179.
• Background Lawrence JA, Griffin L, Balcueva EP, Groteluschen DL, Samuel TA, Lesser GJ, Naughton MJ, Case LD, Shaw EG, Rapp SR. A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy. J Cancer Surviv. 2016 Feb;10(1):176-84. doi: 10.1007/s11764-015-0463-x. Epub 2015 Jul 1.
• Background Tong T, Pei C, Chen J, Lv Q, Zhang F, Cheng Z. Efficacy of Acupuncture Therapy for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients. Med Sci Monit. 2018 May 8;24:2919-2927. doi: 10.12659/MSM.909712.
• Background Kaur T, Kaur G. Withania somnifera as a potential candidate to ameliorate high fat diet-induced anxiety and neuroinflammation. J Neuroinflammation. 2017 Oct 12;14(1):201. doi: 10.1186/s12974-017-0975-6.
• Background Kuboyama T, Tohda C, Komatsu K. Effects of Ashwagandha (roots of Withania somnifera) on neurodegenerative diseases. Biol Pharm Bull. 2014;37(6):892-7. doi: 10.1248/bpb.b14-00022.
• Background Gupta M, Kaur G. Aqueous extract from the Withania somnifera leaves as a potential anti-neuroinflammatory agent: a mechanistic study. J Neuroinflammation. 2016 Aug 22;13(1):193. doi: 10.1186/s12974-016-0650-3.
• Background Pingali U, Pilli R, Fatima N. Effect of standardized aqueous extract of Withania somnifera on tests of cognitive and psychomotor performance in healthy human participants. Pharmacognosy Res. 2014 Jan;6(1):12-8. doi: 10.4103/0974-8490.122912.
• Background Chengappa KN, Bowie CR, Schlicht PJ, Fleet D, Brar JS, Jindal R. Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. J Clin Psychiatry. 2013 Nov;74(11):1076-83. doi: 10.4088/JCP.13m08413.
• Background Choudhary D, Bhattacharyya S, Bose S. Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions. J Diet Suppl. 2017 Nov 2;14(6):599-612. doi: 10.1080/19390211.2017.1284970. Epub 2017 Feb 21.
• Background Biswal BM, Sulaiman SA, Ismail HC, Zakaria H, Musa KI. Effect of Withania somnifera (Ashwagandha) on the development of chemotherapy-induced fatigue and quality of life in breast cancer patients. Integr Cancer Ther. 2013 Jul;12(4):312-22. doi: 10.1177/1534735412464551. Epub 2012 Nov 9.
• Background Panda S, Kar A. Changes in thyroid hormone concentrations after administration of ashwagandha root extract to adult male mice. J Pharm Pharmacol. 1998 Sep;50(9):1065-8. doi: 10.1111/j.2042-7158.1998.tb06923.x.
• Background Panda S, Kar A. Withania somnifera and Bauhinia purpurea in the regulation of circulating thyroid hormone concentrations in female mice. J Ethnopharmacol. 1999 Nov 1;67(2):233-9. doi: 10.1016/s0378-8741(99)00018-5.
• Background Sharma AK, Basu I, Singh S. Efficacy and Safety of Ashwagandha Root Extract in Subclinical Hypothyroid Patients: A Double-Blind, Randomized Placebo-Controlled Trial. J Altern Complement Med. 2018 Mar;24(3):243-248. doi: 10.1089/acm.2017.0183. Epub 2017 Aug 22.
• Heo JU, Rao S, Newton HB, Dowlati A, Muzic RF Jr, Kardan A. Phase 1 Trial of Withania somnifera Leaf Extract (RH324) in Advanced Non-Small Cell Lung Cancer Including [18F]FDG PET/CT as a Short-Term Metabolic Biomarker to Assess Efficacy: A Novel Model for Assessment of Complimentary Therapies in Early Phase Human Clinical Trials. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251410182. doi: 10.1177/15347354251410182. Epub 2026 Feb 13.

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