A clinical trial to study the effects of the combination of modified Buerger-Allen exercise with Epsom-salt foot bath for the management of Chemotherapy-Induced peripheral neuropathy among breast cancer patients
- Conditions
- Malignant neoplasm of breast,
- Registration Number
- CTRI/2023/07/055716
- Lead Sponsor
- Rahul shil
- Brief Summary
**BRIEF SUMMARY OF THE PROPOSAL**
**Title of the proposed research project:** Evaluation of comparative efficacy of the combination of modified Buerger-Allen exercise and Epsom-salt foot bath as against modified Buerger-Allen exercise and Epsom-salt foot bath alone for the management of chemotherapy-induced peripheral neuropathy in breast cancer patients – A randomized controlled trial.
**Summary:**
**Study objectives:**
**Primary Objectives:**
**Symptomatic group:**
1. To assess the baseline data of chemotherapy-induced peripheral neuropathy among breast cancer cases.
2. To evaluate and compare the variation in the symptoms of CIPN after the intervention of combination therapy of Modified Buerger-Allen exercise with Epsom salt foot bath.
3. To evaluate and compare the variation in the symptoms of CIPN after intervention with Epsom salt foot bath individually.
4. To evaluate and compare the variation in the symptoms of CIPN after the intervention of Modified Buerger-Allen exercise alone.
5. To compare the outcome of alleviating the CIPN symptoms in all 3 symptomatic groups.
**Asymptomatic group:**
1. To assess the baseline data of chemotherapy-induced peripheral neuropathy among breast cancer cases.
2. To evaluate and compare the variation in the onset of the development of symptoms of peripheral neuropathy after the intervention in all three groups.
3. To evaluate and compare whether the combination therapy can prevent the development of CIPN after the end of the chemotherapy cycle in all three groups
**Secondary Objectives:**
1. To assess and compare the quality of life (QOL) for breast cancer patients and baseline and at the end line (during the interval of 1st to final cycle).
**Expected outcome:**
1. Modified Buergers-Allen exercise with Epsom salt foot bath may be used as an effective non-pharmacological measure to treat chemotherapy-induced peripheral neuropathy for breast cancer patients compared to modified BAE and Epsom salt foot bath alone.
2. By generating new knowledge from this research, we can able to have a better understanding of the modified Buergers-Allen exercise with Epsom salt foot bath compared to conventional treatment for CIPN among breast cancer patients.
3. The exercise may also improve the overall QOL of breast cancer patients during chemotherapy.
**Keywords:** comparative efficacy, modified Buerger-Allen exercise, Epsom-salt foot bath, chemotherapy-induced peripheral neuropathy, breast cancer, Randomized controlled trial.
**Abbreviations:**BAE, CIPN, RCT
**Project Description:**
**Study setting:**The study will be conducted in Acharya Vinoba Bhave Rural Hospital (AVBRH) in Wardha, Maharashtra.
**Study Design:**Three-arm single blinded triple parallel randomized clinical study.
**Sampling strategy:** non-probability purposive sampling technique will be used in the study.
**Sample size:** 180 patients will be selected which will be divided into six equal groups, first-time receiving chemotherapy yet to develop the symptoms of CIPN (asymptomatic) and multiple-time received chemotherapy with mild to moderate CIPN symptoms in experimental and control groups each.
**Ethical issue:** Ethical clearance is obtained from the institutional ethical committee of DMIMS University.
**Hypotheses:**
**H01: (Null Hypothesis):**There is no significant improvement in the symptoms of peripheral neuropathy in the combination of modified BAE and Epsom-salt foot bath as compared to Epsom salt and modified BAE alone indelaying or preventing symptoms of CIPN between control & experimental asymptomatic group
**H1 (Alternative Hypothesis):**There is a significant improvement in the symptoms of peripheral neuropathy in the combination of modified BAE and Epsom-salt foot bath as compared to Epsom salt and modified BAE alone indelaying or preventing symptoms of CIPN between control & experimental asymptomatic group
**H02 (Null Hypotheses):**There is no significant relief in the symptoms of peripheral neuropathy in the combination of modified BAE and Epsom salt foot bath as compared to Epsom salt and modified BAE alone indelaying or preventing symptoms of CIPN between control & experimental symptomatic group
**H2 (Alternative Hypothesis):** There is a relief in the symptoms of peripheral neuropathy in the combination of modified BAE and Epsom salt foot bath as compared to Epsom salt and modified BAE alone in delaying or preventing symptoms of CIPN between control & experimental symptomatic group
**Future plan based on expected outcomes:**The investigator will present the study outcome at an international conference and also he will publish papers related to a systematic review, protocol publication, and a review article. Furthermore, after the Ph.D. the investigator will try to find out more in-depth refine ways to practice the proposed intervention in international universities for his Post-doctoral study.
**Timelines:** The timeline of this proposed study will be till May 2024.
**Skill and experience of the research team**: The primary investigator is currently working as an Associate professor in the Department of MSN (Neuroscience) and pursuing this research as his Ph.D. study. He is currently working on multiple projects and published 10 research papers to date, and 3 papers are under review in Scopus and Web of Science-indexed journals. He is also working as a Co-researcher in Malaysia. Recently he is awarded a research grant from Malaysia for a collaborative research project.
Rahul shil
**Signature of the Principal Investigator**
Date: 11/06/2023
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 180
Symptomatic CIPN Breast cancer patients and asymptomatic CIPN breast cancer patients.
- 1.Patients who are terminally ill and having psychiatric conditions.
- 2.Patients who are suffering from diabetes, Diabetic neuropathy and other neurological symptoms.
- 3.Patients suffering from any other musculoskeletal disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Buergers Allen exercise with Epsom salt foot bath may be used as an effective non pharmacological measures to treat chemotherapy induced peripheral neuropathy for breast cancer patients compared to BAE & Epsom salt foot bath alone 2nd / 3rd cycle chemotherapy for the baseline assessment and following assessment on 4th, 5th, and 6th cycle for symptomatic cases and 1st cycle chemotherapy for the baseline assessment and following assessment on 2nd, 3rd, 4th, 5th, and 6th assessment for asymptomatic cases
- Secondary Outcome Measures
Name Time Method The combination of modified Buerger-Allen exercise & Epsom-salt foot bath may also improve the overall quality of life of breast cancer patients during chemotherapy The quality of life will be checked in both symptomatic & asymptomatic breast cancer patients after each cycle of chemotherapy. 2nd / 3rd cycle chemotherapy for the baseline assessment & following assessment on 4th, 5th, & 6th cycle for symptomatic cases & 1st cycle chemotherapy for the baseline assessment & following assessment on 2nd, 3rd, 4th, 5th, & 6th assessment for asymptomatic cases.
Trial Locations
- Locations (1)
Datta Meghe Institute of Higher Educationand Research Wardha Maharashtra 442001.
🇮🇳Wardha, MAHARASHTRA, India
Datta Meghe Institute of Higher Educationand Research Wardha Maharashtra 442001.🇮🇳Wardha, MAHARASHTRA, IndiaDr Ruchira AnkarPrincipal investigator7620978673ruchira.shende@rediffmail.com