Acupuncture for the Improvement of Cognitive Difficulties in Breast, Colorectal, and Gynecological Cancer Survivors, the CLARITY Study

Status: Active

Description

This phase II trial studies how well acupuncture works in improving cognitive difficulties in breast, colorectal, and gynecological cancer survivors. Some treatments used for cancer can cause long-term side effects, such as cognitive difficulties. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. It has been widely used to treat pain, but researchers think acupuncture may help improve the cognitive difficulties and insomnia that many cancer survivors report following chemotherapy and other cancer treatments.

Eligibility Criteria

Inclusion Criteria

  • English-speaking
  • History of stage I, II, or III cancer (breast, colorectal, gynecological)
  • Free of oncologic disease by clinical examination and history
  • Must report moderate or greater perceived CD as indicated by a score of “quite a bit” or “very much” on at least one of the two items that specifically assess concentration (item #20) and memory (item #25) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) instrument (version 3.0)
  • Must indicate that their cognitive functions have worsened since their cancer diagnosis by replying “yes” to all of the following questions: * Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis? * Do you think your mind isn’t as sharp now as it was before your cancer diagnosis? * Do you feel like these problems have made it harder to function on your job or take care of things around the home?
  • Must be willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control

Exclusion Criteria

  • Metastatic cancer (stage IV)
  • Less than 3 months since completion of chemotherapy or radiation therapy
  • Greater than 5 years since cancer diagnosis (breast, colorectal, gynecological)
  • Use of acupuncture for symptom management within the past 3 months
  • Diagnosis of Alzheimer’s disease, vascular dementia, Parkinson disease, or other organic brain disorder
  • Score of >= 10 on the Blessed Orientation-Memory-Concentration (BOMC) screening instrument
  • Primary psychiatric disorder not in remission
  • Motor impairments that interfere with ability to write or use a keyboard
  • Visual impairments (not correctable by glasses, contact lens, etc.) that interfere with ability to view images on a page or computer screen
  • Auditory impairments (not correctable by hearing aids) that interfere with ability to comprehend verbal instructions
  • Initiation or change in hormonal adjuvant therapy within the past 4 weeks
  • Plans to initiate or change hormonal treatment in the coming 8 weeks
  • Altered dose of somnogenic medication (e.g. hypnotics, sedatives, and/or antidepressants) in the past 8 weeks

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To obtain preliminary data on the magnitude of effect of an acupuncture intervention to improve perceived cognitive difficulties (CD) among breast, colorectal, and gynecological cancer survivors.

SECONDARY OBJECTIVES:

I. To obtain preliminary data on the magnitude of effect of an acupuncture intervention to improve insomnia among cancer survivors.

II. To evaluate the association between sleep- and cognition-related outcomes.

III. To evaluate the safety of acupuncture for perceived CD and insomnia in cancer survivors.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo acupuncture over 30-45 minutes once weekly for up to 10 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16.

GROUP II: Patients undergo sham acupuncture over 30-45 minutes once weekly for up to 10 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16.

GROUP III: Patients are put on a wait-list and receive standard of care for 16 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16. After week 16, patients may optionally undergo acupuncture.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Jun J Mao

Trial IDs

Primary ID 19-179
Secondary IDs NCI-2019-05719
Clinicaltrials.gov ID NCT04007770