NCT04621721: B-HAPI

Home-Based Physical Activity Intervention for Taxane-Induced CIPN

Status unknown NA Last updated 9 November 2020

What this trial tests

NA trial testing Gait/balance & resistive exercise in Breast Cancer Female in 312 participants. Status unknown.

Timeline

14 August 2020

Primary endpoint
30 July 2024

30 September 2024

Quick facts

Lead sponsor	University of South Florida
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	312
Start date	14 August 2020
Primary completion	30 July 2024
Estimated completion	30 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Gait/balance & resistive exercise

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →
• Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →
• Balance; Distorted — all drugs for Balance; Distorted →

Sponsor

University of South Florida

Who can join

21 and older, female only, with Breast Cancer Female or Chemotherapy-induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This two-group, randomized control trial (RCT) will test the effects of a home-based, 16 week gait/balance training plus resistance (exercise bands) exercise program as compared to an educational cancer survivorship attention control condition to address persistent taxane-induced peripheral neuropathy in 312 patients treated for invasive breast cancer with taxanes at 1 year or more after completion of therapy. Assessments of lower extremity muscle strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will be performed.

The proposed exercise intervention addresses gait/balance impairments and motor (resistance) components of taxane-induced peripheral neuropathy. The mechanism by which the intervention achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and clinical manifestations of peripheral neuropathy, while improving gait/balance in those with persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria to function more efficiently, and may alleviate the neuropathic manifestations of taxane-induced peripheral neuropathy. 15

This is the first study proposing to test the home-delivery of an exercise intervention specifically aimed at persistent (long-term) taxane-induced neuropathy. If successful, this study will provide the only evidence-based intervention for patients suffering from persistent neuropathy from neurotoxic chemotherapy. Additionally, the home-delivery format makes this intervention easily translated into clinical practice.

Specific Aims:

In a sample of patients who completed a taxane-containing chemotherapy regimen (\> 1 year) for breast cancer and who have a persistent neuropathy (VAS score of \> 3) the specific aims of this RCT are:

1. To test the efficacy of a 16-week -delivered program of gait/balance training plus resistance exercise, compared to an educational attention control condition in increasing muscle strength, improving gait/balance and nerve conduction parameters, decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing quality of life.
2. To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor (peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL) between patients who receive the exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles and intervals, neuropathic pain, neuropathy/pain medications, current resistance exercise participation and falls/near falls experienced.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Approaches for the Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Therapeutic Potential of the C5a/C5aR Axis.
   Spera MC, Cesta MC, Zippoli M, Varrassi G, et al · · 2022 · cited 10× · PMID 36098939 · DOI 10.1007/s40122-022-00431-8
2. Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial.
   Teran-Wodzinski P, Haladay D, Vu T, Ji M, et al · · 2022 · cited 8× · PMID 35477489 · DOI 10.1186/s13063-022-06294-w
3. Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial.
   Ozorio Dutra SV, Schwab L, Coury J, Ji M, et al · · 2024 · cited 1× · PMID 38937667 · DOI 10.1186/s12885-024-12444-x