Clinical trial NCT03292328: Yoga for Symptoms of Nerve Damage Caused by Chemotherapy
Official title: Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Peripheral Neuropathy
Gynecologic Cancer
Keywords: breast cancer
neuropathy
peripheral neuropathy
yoga
17-449
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Some types of chemotherapy used to treat breast cancer can cause damage to nerves with symptoms like tingling, numbness, muscle weakness, and pain in the hands and feet that can last and can affect functioning. The purpose of this study is to find out the effects of yoga on reducing symptoms caused by such nerve damage.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age \>/= 18 years old
* Survivors with a primary diagnosis of stage I-III breast, ovarian uterine, or endometrial cancer
* Moderate to severe chemotherapy induced peripheral neuropathy, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale
* Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
* If taking anti-neuropathy medications, they are on a stable regiment (no change in 3 months)
* ECOG performance status 0-2

Exclusion Criteria:

* Participants with metastatic disease
* Participants who are currently receiving physical therapy or practicing yoga for any reason

Control Group - Inclusion/Exclusion Criteria

Inclusion Criteria:

* English speaking
* Age \>/= 18 years old
* Survivors with a primary diagnosis of Stage I-III breast, ovarian, uterine, or endometrial cancer
* CIPN symptoms such as numbness, tingling, or pain ratings \< 2 on a 0-10 NRS scale
* Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
* ECOG performance status 0-2

Exclusion Criteria:

* Patients with metastatic disease
* Patients taking anti-neuropathy medication
* Patients who are currently receiving physical therapy or practicing yoga for any reason

Primary outcomes:
measure: Change in treatment related peripheral neuropathy symptoms
timeFrame: 8 weeks of the participants' most bothersome peripheral neuropathy symptom
Secondary outcomes:
Other outcomes:
Locations:
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ting Bao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhi WI, Baser RE, Zhi LM, Talukder D, Li QS, Paul T, Patterson C, Piulson L, Seluzicki C, Galantino ML, Bao T. Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes. Cancer Med. 2021 Aug;10(16):5456-5465. doi: 10.1002/cam4.4098. Epub 2021 Jul 2.
citation: Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.