To study the effect of Deuterium depleted water in patients receiving neoadjuvant chemotherapy (NACT) for triple negative (TNBC) or HER2 positive breast cancer

A Phase II randomized controlled trial of Deuterium Depleted Water (DDW) administration or regular water in patients receiving neoadjuvant chemotherapy (NACT) for triple negative (TNBC) or HER2 positive breast cancer - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068676

Enrollment

228

Registered

2024-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Deuterium depleted water: Dose: Not applicable Deuterium level: 80+/-5 ppm Route of administration: Oral Frequency: Not applicable, The patients randomiized to eperimental arm will be d

Eligibility

Inclusion criteria

Inclusion criteria: 1. All individuals above 18 years of age having histopathologicaly proven, triple negative breast cancer (mTNBC) or Her-2 positive breast cancer who are going to receive neo-adjuvant chemotherapy. 2. Has a performance status of 0-3 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 3. Willing and able to provide written informed consent and able to comply with all trial procedures.

Exclusion criteria

Exclusion criteria: 1. Patients who do not have histopathologicaly proven triple negative breast cancer (mTNBC) or Her-2 positive breast cancer 2. Patients who are not eligible for neo-adjuvant chemotherapy.

Design outcomes

Primary

Measure	Time frame
The fraction of patients in both arms who achieve pathological complete response (pCR) defined as absence of invasive cancer from the primary breast surgical specimen and the axillary/ non-axillary lymph nodes.Timepoint: At 6 months from the surgical specimen post neo-adjuvant chemotherapy.	—

Secondary

Measure	Time frame
Disease-free survival (DFS) in both arms (event defined as any relapse of invasive breast cancer, any contralateral invasive breast cancer, any other invasive breast cancer, or death due to any cause, whichever occurs first).Timepoint: 2 year;The fractions of patients who achieve more than 80% Compliance to the DDW in the experimental arm.Timepoint: Post completion of NACT;To estimate the fraction of patients in both study arms who achieve other definition of pathological complete response, taken as the absence of residual invasive cancer or absence of residual invasive cancer plus in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neo adjuvant systemic therapy. Timepoint: Evaluated from surgical specimen post NACT.;To evaluate the fraction of patients in both study arms who experience any grade of hematological and non hematological toxicities. Timepoint: First cycle of NACT to last cycle of NACT	—

Measure

Time frame

Disease-free survival (DFS) in both arms (event defined as any relapse of invasive breast cancer, any contralateral invasive breast cancer, any other invasive breast cancer, or death due to any cause, whichever occurs first).Timepoint: 2 year;The fractions of patients who achieve more than 80% Compliance to the DDW in the experimental arm.Timepoint: Post completion of NACT;To estimate the fraction of patients in both study arms who achieve other definition of pathological complete response, taken as the absence of residual invasive cancer or absence of residual invasive cancer plus in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neo adjuvant systemic therapy. Timepoint: Evaluated from surgical specimen post NACT.;To evaluate the fraction of patients in both study arms who experience any grade of hematological and non hematological toxicities. Timepoint: First cycle of NACT to last cycle of NACT

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Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Centre

sudeepgupta04@yahoo.com02224177201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026