Ashwagandha for Cognitive Dysfunction

NCT04092647 | Unknown Phase 2 FDA Drug

• 1 other identifier: SIMR_onc19_IIS_Behl_Ashwaga
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemo Fog

Keywords

ashwagandha; cognitive dysfunction; cancer chemotherapy

Outcome Measures

Primary Outcomes (1)

• FACT-Cog PCI

  The Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) is a 37-item questionnaire designed to assess cognitive complaints in patients with cancer. The Perceived Cognitive Impairment (PCI) subscale consists of 20 items designed to measure perceived impairment in quality of life. Scores range from 0-72 where higher scores indicate less impairment and better quality of life.

  9 weeks

Study Arms (2)

ashwagandha

EXPERIMENTAL

Ashwagandha

Drug: Ashwagandha

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ashwagandha DRUG

Ashwagandha 350 mg po BID

ashwagandha

Placebo DRUG

Placebo 350 mg po BID

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• English speaking
• Currently undergoing chemotherapy or treatment with chemotherapy in the past year
• Self-reported memory loss, attention, visual-spatial functioning, reasoning, or information processing or cognitive changes in the first 2 cycles of chemotherapy and score \< 63 on the FACT-Cog PCI
• Able to follow instructions for testing and comply with testing
• Able to swallow pills

You may not qualify if:

• Undergoing treatment for any hormone dependent cancer
• Planned surgical treatment
• History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury
• History of hypotension
• Active autoimmune disease
• Brain metastasis
• Taking any drugs daily that would alter cognition
• Concurrent use of benzodiazepenes or other sedatives
• Concurrent use of supplements that can cause sedation such as 5-HTP, calamus, California poppy, hops, Jamaican dogwood, kava, St.John's Wort, skullcap, valerian, yerba mansa
• Currently taking hypoglycemic medications
• History of substance abuse
• Current or recent diagnosis of stomach ulcer or gastritis

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

Sutter Cancer Center

Sacramento, California, 95816, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 28029304 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.

  PMID: 11786578 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.

  PMID: 17131349 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.

  PMID: 20564075 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.

  PMID: 30231372 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.

  PMID: 26130292 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.

  PMID: 29735975 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.

  PMID: 29025435 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.

  PMID: 24882401 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.

  PMID: 27550017 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.

  PMID: 24497737 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.

  PMID: 24330893 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.

  PMID: 28471731 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.

  PMID: 23142798 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.

  PMID: 9811169 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.

  PMID: 10619390 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.

  PMID: 28829155 BACKGROUND

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Deepti Behl, MD

  Sutter Health

  PRINCIPAL INVESTIGATOR

• Carol Parise, PhD

  Sutter Health

  STUDY DIRECTOR

Central Study Contacts

Michele Guillen

CONTACT

9168874656; guillem1@sutterhealth.org

Carol Parise, PhD

CONTACT

9168874744; parisec@sutterhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a 1:1 randomized double blinded placebo controlled trial.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)