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Couples-Based Yoga for Brain Cancer

N/A

Waitlist Available

Led By Kathrin Milbury

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status (KPS) of 80 or above

Diagnosed with a primary glioma and going to receive at least 4 weeks of radiotherapy with at least 20 fractions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a yoga program can improve quality of life for patients with brain cancer and their partners.

Who is the study for?

This trial is for English-speaking couples where one partner has a high-grade glioma brain tumor and will undergo radiation therapy. The patient must be fairly active (KPS of 80+) and have a caregiver willing to join the yoga program. Patients with short life expectancy, cognitive deficits, or recent regular yoga practice are excluded.

What is being tested?

The study tests if a Hatha yoga program can improve quality of life, reduce fatigue and distress, and enhance sleep for patients with high-grade glioma and their partners during radiation treatment.

What are the potential side effects?

Yoga is generally safe but may include mild discomfort or muscle strain. It's important to adjust poses to individual abilities to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can carry out normal activities with minimal symptoms.

Select...

I have a brain tumor and will undergo radiotherapy with 20 or more sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of a couple-based yoga program determined by adherence

Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36

Secondary study objectives

Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181

73%

Fatigue

71%

Palmar-plantar erythrodysesthesia syndrome

63%

Hypertension

61%

Papulopustular rash

55%

Diarrhea

51%

Nausea

39%

Myalgia

37%

Alopecia

35%

Arthralgia

33%

Abdominal pain

31%

Anorexia

27%

Vomiting

22%

Mucositis oral

22%

Constipation

18%

Anemia

18%

Alanine aminotransferase increased

16%

Platelet count decreased

14%

Pruritus

14%

Hyperglycemia

14%

Rash maculo-papular

14%

Skin and subcutaneous tissue disorders - Other, specify

12%

Aspartate aminotransferase increased

12%

Rash acneiform

12%

Peripheral sensory neuropathy

10%

Investigations - Other, specify

10%

Dry skin

10%

Neutrophil count decreased

10%

Blood bilirubin increased

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (couple-based Hatha yoga program)Experimental Treatment4 Interventions

Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a DVD and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor.

Group II: Arm II (waitlist control)Active Control3 Interventions

Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.

0 / 2Eligibility criteria met